These Regulations are adopted pursuant to Article 144, paragraph 1 of the Insurance Act.

Before selling any type of insurance product, an insurance enterprise shall comply with all of the procedures set out in these Regulations, except where otherwise provided by applicable acts or where the competent authority has given approval for a product of a special nature.
The term "insurance product" in the preceding paragraph means the types of non-life insurance and life insurance specified in Article 13 of the Insurance Act, and its content includes insurance policy provisions, a proposal, premiums, and other related materials as designated by the competent authority.

The "pre-sale procedures for insurance products" in these Regulations include the following three procedures:
1. "Procedures for design of insurance products", which means the procedures involved from the time of research and development until (but not including) submission of the product for review.
2. "Procedures for review of insurance products", which means the procedures for submission of the product for review by the competent authority following completion of the design procedures.
3. "Procedures for preparation for sale of insurance products", which means the procedures involved from the time review is completed until (but not including) commencement of product sales.

Procedures for design of insurance products shall include the following steps:
1. Product research and development.
2. Formal product development: including formulation of policy provisions, risk management manual and the pricing actuarial memorandum.
3. Preparation for submission for review.
The procedures for design of insurance products under the preceding paragraph, and any amendments thereto, shall be reported to the competent authority for recordation.

Before an insurance enterprise submits an insurance product to the competent authority for review, the product shall be evaluated by [the enterprise's] insurance product evaluation team. Minutes of each team meeting shall be maintained on file, submitted to the general manager for review, and kept available for inspection by the competent authority.
The vice general manager (or someone of equivalent rank) shall serve as the chairperson of the insurance product evaluation team referred to in the preceding paragraph. Relevant signatories or their deputies shall attend team meetings and participate in the adoption of resolutions.

An insurance enterprise shall rigorously execute the following matters when undertaking research and development of insurance products:
1.Assessing the appropriateness and legality of the insurance product.
2.Assessing premium levels and market competitiveness.
3.Assessing the feasibility of system administration.
4.Assessing policy objectives and establishing feasible courses of action. Such assessment shall focus on insurance product design, devoting concrete attention to such matters as due professional care, due care of a good administrator, target market, and safeguarding of consumer interests.
5.When designing an insurance product, there may not be any false, fraudulent, or exaggerated claims about the insurance enterprise's performance, or any other act sufficient to mislead other persons.
6. Evaluating the effectiveness of the risk management system.
7. Evaluating the potential effects and disadvantages associated with the characteristics of insurance products on customers over 65 years of age, including evaluating whether the product is suitable for selling to customers over 65 years of age.

An insurance enterprise shall rigorously execute the following matters when formulating policy provisions during formal insurance products development:
1. Drafting policy provisions on the basis of the content of the product's design.
2. Inspecting the text of policy provisions for clarity and definitiveness of wording and meaning.
3. Ascertaining compliance with insurance-related acts and regulations.
4. Reviewing past experience with complaints, arbitration, and litigation connected with insurance products that are similar in nature, and clearly setting forth the rights and obligations of proposers, insureds, and beneficiaries.
5. Making adjustments to ensure legal compliance when introducing an insurance product based on a foreign product.

An insurance enterprise shall rigorously execute the following matters when formulating the pricing actuarial memorandum during formal development of non-life insurance products:
1. Determining benefit items and collecting reference information for premium rate-setting, confirming the correlation between the experience data used and the rate-setting, and that the experience data meet the following criteria, and that premium rates are adequate, reasonable and fair, and reflect costs and reasonable profits, and the enterprise shall not solicit or conduct insurance business by offering unreasonable prices:
(1) The experience data should use statistical data in the past 3 – 5 years and should be principally domestic data, and may include the enterprise’s own experience data. However if no statistical data in the past 3-5 years are available, comparable foreign data may be used.
(2) The setting of expected incidence rate in reference to domestic and foreign data should be commensurate with payment terms and conditions and exclusions stated in the insurance policy.
(3) The enterprise should understand clearly the domestic and foreign data used and obtain the source data, and should not just use the incidence rate provided by reinsurance companies. The data used should be completely consistent with the payment terms and conditions in the insurance policy. If it is not entirely consistent, the enterprise should describe the difference and analyze whether the difference affects the premium rate setting.
2.Determining the basis for pricing of the risk.
3.Determining the method for calculation of premium rates.
4.Evaluating reinsurance arrangements.
5.Risk management mechanisms.
Premium rate - making mentioned in the preceding paragraph shall be carried out in accordance with the rates checking mechanism approved by the competent authority based on the characteristics of insurance product or the reference rate range set by an institution designated by the competent authority.
When an insurance enterprise formulates a risk management manual in the formal development of non-life insurance products, the manual shall include at least reinsurance arrangement, early warning and control mechanisms for evaluating sales limits, and shall state that the sales limits are commensurate with the risk appetite set by the company.

An insurance enterprise shall rigorously execute the following matters when formulating the pricing actuarial memorandum during formal development of life insurance products:
1. Determining benefit items and collecting reference information for premium rate-setting, confirming the correlation between the experience data used and the rate-setting, and that the experience data meet the following criteria, and that premium rates are adequate, reasonable and fair, and reflect costs and reasonable profits, and the enterprise shall not solicit or conduct insurance business by offering unreasonable prices:
(1) The experience data should use statistical data in the past 3 – 5 years and should be principally domestic data, and may include the enterprise’s own experience data. However if no statistical data in the past 3-5 years are available, comparable foreign data may be used.
(2) The setting of expected incidence rate in reference to domestic and foreign data should be commensurate with payment terms and conditions and exclusions stated in the insurance policy.
(3) The enterprise should understand clearly the domestic and foreign data used and obtain the source data, and should not just use the incidence rate provided by reinsurance companies. The data used should be completely consistent with the payment terms and conditions in the insurance policy.
2.Setting limits on the insuring age and insuring amounts, and determining the method of premium payment.
3.Undertaking trial calculation of premiums.
4.Calculating reserves and contract amendments.
5.Carrying out pricing analysis and risk assessment.
6. Evaluating reinsurance arrangements.
7. Risk management mechanisms.
A life insurance enterprise shall rigorously execute the following matters when carrying out pricing analysis and risk assessment under subparagraph 5 of the preceding paragraph:
1.Analyzing the reasonableness of assumptions used.
2.Analyzing various profit benchmarks (including analysis of product profits, plus analysis of either asset share or the break-even point).
3.Reviewing the appropriateness of risk assessment results (including testing of actuarial data and sensitivity analysis).
4.Inspecting the text of policy provisions and the pricing actuarial memorandum for consistency.
When an insurance enterprise formulates a risk management manual in the formal development of life insurance products, the manual shall include at least reinsurance arrangement, early warning and control mechanisms for evaluating sales limits, and state that the sales limits are commensurate with the risk appetite set by the company.

Before an insurance enterprise submits an insurance product for review, the general manager (or a department head authorized thereby) and qualified signatories shall sign off on the product.
The general manager shall bear joint liability for the actions of any department head that he/she authorizes, and is also responsible for supervising signatories.
One person may not serve concurrently as two or more of the signatories referred to in paragraph 1.

When a non-life insurance product is submitted for review, the term "qualified signatories" in paragraph 1 of the preceding article means personnel with the following qualifications who are designated by the insurance enterprise to bear responsibility and sign for the insurance product, unless it is otherwise provided by the competent authority:
1. Underwriters: Those qualified as underwriters under Article 12 of the Regulations Governing Business Solicitation, Policy Underwriting, and Claim Adjusting of Insurance Enterprises, and possessing three years or more of actual experience handling relevant insurance underwriting either at home or abroad.
2. Claims adjusters: Those qualified as claims adjusters under Article 13 of the Regulations Governing Business Solicitation, Policy Underwriting, and Claim Adjusting of Insurance Enterprises, and possessing three years or more of actual experience handling relevant insurance claims adjustment either at home or abroad.
3. Actuaries: Those who have three years or more of actual experience handling relevant insurance actuarial work and possess any one of the following qualifications:
(1) Qualified as actuaries under Article 2, paragraph 2 of the Regulations Governing Appointed Actuaries and External Reviewing Actuaries of Insurance Enterprises whose qualification as an appointed actuary has not been revoked by the competent authority or whose period of suspension from working as an appointed actuary as imposed by the competent authority has expired, and possessing three years or more of actual experience handling relevant insurance actuarial work either at home or abroad.
(2) Having passed the examination conducted by a domestic academic insurance institution recognized by the competent authority and obtained the certificate of signatory actuary for non-life insurance products therefrom.
4. Legal affairs personnel: Those possessing any one of the following qualifications:
(1) Attorneys qualified to practice under the Attorney Regulation Act.
(2) Graduates of an insurance or law department at a domestic educational institution at the level of junior college or higher who have five or more years of actual work experience supervising insurance-related legal affairs.
(3) Having been in charge of the legal affairs department at an insurance enterprise and has actually served in that capacity for five years or more.
(4) Having worked for eight years or more in the legal affairs department of an insurance enterprise.
(5) Educators who have taught insurance law in an insurance or law department of a domestic educational institution at the level of junior college or higher.
5. Investment personnel: Supervisors of investment-related departments who have three years or more of actual experience at home or abroad handling financial, securities, or other investment affairs.
6. Risk management personnel: Supervisors of risk management related departments who have three years or more of actual experience at home or abroad handling financial, investment, actuarial, underwriting or risk management affairs of an insurance enterprise.
Article 12, paragraph 1, subparagraphs 5 and 6, and paragraph 2 herein apply mutatis mutandis to non-life insurance products mentioned in Article 16, paragraph 1, subparagraph 1 submitted by an insurance enterprise for review.

When a life insurance product is submitted for review, the term "qualified signatories" in Article 10, paragraph 1 means personnel with the following qualifications who are designated by the insurance enterprise to bear responsibility and sign for the insurance product, unless it is otherwise provided by the competent authority:
1. Underwriters: Those qualified as underwriters under Article 12 of the Regulations Governing Business Solicitation, Policy Underwriting, and Claim Adjusting of Insurance Enterprises, and possessing three years or more of actual experience handling relevant insurance underwriting either at home or abroad.
2. Claims adjusters: Those qualified as claims adjusters under Article 13 of the Regulations Governing Business Solicitation, Policy Underwriting, and Claim Adjusting of Insurance Enterprises, and possessing three years or more of actual experience handling relevant insurance claims adjustment either at home or abroad.
3. Actuaries: Those who possess any one of the following qualifications:
(1) Qualified as actuaries under Article 2, paragraph 2 of the Regulations Governing Appointed Actuaries and External Reviewing Actuaries of Insurance Enterprises whose qualification as an appointed actuary has not been revoked by the competent authority or whose period of suspension from working as an appointed actuary as imposed by the competent authority has expired, and possessing three years or more of actual experience handling relevant insurance actuarial work either at home or abroad.
(2) Having passed the examination conducted by a domestic academic insurance institution recognized by the competent authority and obtained the certificate of signatory actuary for non-life insurance products therefrom, and having three years or more of actual experience handling actuarial work related to health and injury insurance, where such actuarial work must include being a signatory for health and injury insurance products submitted (to the competent authority) by a non-life insurance enterprise for review.
4. Legal affairs personnel: Those possessing any one of the following qualifications:
(1) Attorneys qualified to practice under the Attorney Regulation Act.
(2) Graduates of an insurance or law department at a domestic educational institution at the level of junior college or higher who have five or more years of actual work experience supervising insurance-related legal affairs.
(3) Having been in charge of the legal affairs department at an insurance enterprise and has actually served in that capacity for five years or more.
(4) Having worked for eight years or more in the legal affairs department of an insurance enterprise.
(5) Educators who have taught insurance law in an insurance or law department of a domestic educational institution at the level of junior college or higher.
5. Investment personnel: Supervisors of investment-related departments who have three years or more of actual experience at home or abroad handling financial, securities, or other investment affairs.
6. Insurance conservation personnel: Those who have been the supervisor of a department handling amendments to insurance contracts or related conservation matters, and who have three or more years of actual experience handling amendments to insurance contracts and other insurance conservation-related matters at home or abroad.
7. Risk management personnel: Supervisors of risk management related departments who have three years or more of actual experience at home or abroad handling financial, investment, actuarial, underwriting or risk management affairs of an insurance enterprise.
A department head authorized by the general manager as set out in Article 10, paragraph 1 must have previously been responsible for insurance actuarial work and have one year or more of actual experience at home or abroad handling financial, securities, risk management, or other investment affairs.

When signing an insurance product, the general manager (or a department head authorized thereby) and qualified signatories shall carefully check the factual accuracy, reasonableness, and legality of those for which they are responsible. They shall be responsible for at least the following:
1. General manager or a department head authorized thereby:
(1) The "Description of Insurance Product and Declaration Thereupon".
(2) The "Declaration Form for Submission to the Competent Authority of Insurance Product".
(3) The "Declaration of Partial Insurance Product Modification".
(4) Check the Insurance Product’s “Self-Review Form” to see whether the boxes have been correctly checkmarked.
(5) The proposal.
(6) Completeness of documents submitted for review.
(7) Check whether the insurance product violates the relevant acts or regulations.
(8) Check whether the insurance product is prejudicial to the safeguarding of consumer interests.
(9) Check whether the insurance product violates the insurance enterprise's business strategy, and whether it poses a potential threat to current or future solvency.
(10) Check the appropriateness of asset-liability allocation.
2. Underwriters:
(1) Provisions and declarations pertaining to underwriting in the "Declaration Form for Submission to the Competent Authority of Insurance Product".
(2) Provisions pertaining to underwriting in the "Policy Provision Comparison Table".
(3) The proposal.
(4) The "Declaration of Partial Insurance Product Modification".
(5) Risk management manual.
3. Claims adjusters:
(1) Provisions and declarations pertaining to claims adjustment in the "Declaration Form for Submission to the Competent Authority of Insurance Product".
(2) Provisions pertaining to claims adjustment in the "Policy Provision Comparison Table".
(3) The proposal.
(4) The "Declaration of Partial Insurance Product Modification".
4. Actuaries:
(1) Provisions and declarations pertaining to actuarial work in the "Declaration Form for Submission to the Competent Authority of Insurance Product".
(2) Provisions pertaining to actuarial work in the "Policy Provision Comparison Table".
(3) The proposal.
(4) The "Declaration of Partial Insurance Product Modification".
(5) A pricing actuarial memorandum and other related statements.
(6) The content of the asset-liability allocation plan.
(7) The "Signing Actuary's Assessment Opinion and Declarations Thereupon".
(8) The "Rule Governing Management of the Financial and Operational Aspects of a Participating Life Insurance Policy," "Rule Governing Expense Apportionment and Income Distribution by Participating and Nonparticipating Life Insurance Policies," and "Rule Governing Dividend Participation."
(9) A statement of how the enterprise will respond if the return on investment fails to reach the assumed interest rate (applicable to insurance products with insurance period over one year).
(10) A statement explaining the reasonableness of product pricing.
(11) An assessment of operational risks and risk tolerance.
(12) Risk management manual.
5. Insurance conservation personnel:
(1) Provisions and declarations pertaining to insurance conservation in the "Declaration Form for Submission to the Competent Authority of Insurance Product".
(2) Provisions pertaining to insurance conservation in the "Policy Provision Comparison Table".
(3) The proposal.
(4) The "Declaration of Partial Insurance Product Modification".
6. Legal affairs personnel:
(1) Provisions and declarations pertaining to legal affairs in the "Declaration Form for Submission to the Competent Authority of Insurance Product".
(2) Provisions pertaining to legal affairs in the "Policy Provision Comparison Table".
(3) The proposal.
(4) The "Declaration of Partial Insurance Product Modification".
7. Investment personnel:
(1) Provisions and declarations pertaining to investment in the "Declaration Form for Submission to the Competent Authority of Insurance Product".
(2) Provisions pertaining to investment in the "Policy Provision Comparison Table".
(3) The proposal.
(4) The "Declaration of Partial Insurance Product Modification".
(5) The content of the asset-liability allocation plan.
(6) Investment instrument prospectus.
(7) A statement of how the enterprise will respond if the return on investment fails to reach the assumed interest rate (applicable to insurance products with insurance period over one year).
(8) A check of the inter-relatedness of the product's asset allocation plan and the product's assumed interest rate.
(9) An assessment of investment risks and risk tolerance.
(10) Risk management manual.
8. Risk management personnel
(1) Declaration Form for Submission to the Competent Authority of Insurance Product.
(2) Declaration of Partial Insurance Product Modification.
(3) Check the appropriateness of asset-liability allocation.
(4) Check the impact of the insurance risks and sales of insurance products on risk appetite, and evaluate whether the risk management plan falls within the extent of the company’s acceptable risk appetite.
(5) A statement of how the enterprise will respond if the return on investment fails to reach the assumed interest rate (applicable to insurance products with insurance period over one year).
(6) A check of the inter-relatedness of the product's asset allocation plan and the product's assumed interest rate.
(7) Risk management manual.

An insurance product signatory shall attend at least 15 hours per year of insurance-related professional training held by a training institution designated or recognized by the competent authority.
An insurance product signatory who fails to complete the professional training referred to in the preceding paragraph by the end of a given year may not sign off on insurance products for the insurance enterprise during the following year.
A training institution designated by the competent authority, as referred to in paragraph 1, shall report the content of its training as well as its evaluation standards each year to the competent authority under "file and use" rules.

Any given insurance product shall complete its review procedure in one of the following manners, unless it is otherwise provided by the competent authority:
1. Prior-approval procedure: The insurance enterprise shall apply for approval of the insurance product from the competent authority prior to its sale.
2. Use-and-file procedure: The insurance enterprise may sell the insurance product without prior approval by the competent authority, provided that within 15 working days after product sales begin, the enterprise shall submit materials to the competent authority, or to any institution designated thereby, for recordation.
For the insurance products referred to in subparagraph 1 of the preceding paragraph, the competent authority shall review and respond to the applicant within 40 working days from the day on which it receives in full all application documents, and 75 working days shall decide upon approval or rejection.
Where an insurance product under subparagraph 1 of paragraph 1 hereof is resubmitted for approval within 30 working days after being rejected by the competent authority, the competent authority shall review and respond to the applicant within 25 working days from the day on which it receives in full all application documents, and shall decide upon approval or rejection within 45 working days, to which provisions of paragraph 2 hereof do not apply.

For the following non-life insurance products, an insurance enterprise may commence sale only after applying for and receiving prior approval from the competent authority, unless otherwise provided by the competent authority.
1. An insurance product with a period of insurance or period of insurer liability in excess of three years.
2. A new type of individual insurance product.
Standards for determining what qualifies as a "new type of insurance product" as referred to in subparagraph 2 of the preceding paragraph shall be drafted by the Non-life Insurance Association of the Republic of China and reported to the competent authority for review.
The term "individual insurance" in paragraph 1, subparagraph 2 means insurance in which the proposer is a natural person.

For the insurance products, an internet-only non-life insurance company may commence sale only after applying for and receiving prior approval from the competent authority.
The insurance enterprise sales of an insurance product referred to in the preceding paragraph shall apply for approval of the insurance product from the competent authority prior to its sale.
For an insurance product that has already passed review, if there is subsequently an amendment to its policy provisions, proposal, or pricing actuarial memorandum, or if its premium rates are restructured, shall commence sale only after applying for and receiving prior approval from the competent authority, unless otherwise provided by the competent authority.

For the following life insurance products, an insurance enterprise may commence sale only after applying for and receiving prior approval from the competent authority, unless otherwise provided by the competent authority:
1. An annuity product launched in accordance with the applicable provisions of the Labor Pension Act.
2. An investment-linked insurance product with guaranteed benefits.
3. A new type of insurance product.
4. An insurance product for which the competent authority issues a notice for changing review method in accordance with paragraph 2 of Article 21-1.
Standards for determining what qualifies as a "new type of insurance product" as referred to in subparagraph 3 of the preceding paragraph shall be drafted by the Life Insurance Association of the Republic of China and reported to the competent authority for review.

When an insurance enterprise submits an insurance product for review, it shall do so in accordance with applicable acts and regulations; directions for insurance product review as adopted by the competent authority; and practice principles and self-regulatory rules or codes of professional conduct adopted by domestic professional societies (associations) designated or authorized by the competent authority, or by other relevant entities.
The insurance enterprise shall submit the necessary documents and electronic file thereof as required by the competent authority or any institution designated thereby to the competent authority or any institution designated thereby and provide such information to the competent authority or any institution designated thereby for the construction of an insurance product database.
The documents and electronic file thereof to be submitted under the preceding paragraph shall be prescribed by the competent authority.
After an insurance product has been approved by the competent authority or reported to the competent authority for recordation, the competent authority may provide related information to the public for inquiry and browsing. The related information shall contain at least the following:
1. The "Description of Insurance Product".
2. Policy provisions.
3. The proposal.
4. Rate table: Where no rate table is available, a description of rates shall be provided, unless it is otherwise provided by the competent authority.
5. A list showing the names of the general manager, (or a department head authorized thereby), and the insurance product signatories.
6. Other information as designated by the competent authority.

An insurance enterprise reporting an insurance product to the competent authority for prior approval shall do so within the quota for prior approval set by the competent authority.
Where [an insurance enterprise] has submitted insurance products for review on a prior-approval basis, as referred to in the preceding paragraph, but review has not been completed or a supplementation request from the competent authority has not yet been effected, if the combined number of such submissions exceeds the quota set by the competent authority, the competent authority will refuse to review any other new products that [the insurance enterprise] submits for review.

For an insurance product that has already passed review, if there is subsequently an amendment to its policy provisions, proposal, or pricing actuarial memorandum, or if its premium rates are restructured, such change shall be subject to the use-and-file procedures set out in these Regulations unless the competent authority determines the change is significant or it is for increasing the renewal premium rate of a guaranteed renewable personal health insurance product, in which case the provisions of Article 15, paragraph 1, subparagraph 1 shall govern. The preceding paragraph does not apply if it is otherwise provided by the competent authority.
The preceding paragraph applies to an insurance product that had already passed review before these Regulations went into effect.
For increasing the renewal premium rates of guaranteed renewable personal health insurance products, the insurance enterprise shall take actions in accordance with Subparagraph 1, Paragraph 1 of Article 9 herein, and in addition, three months before the time at which premium will be charged based on the new rate, deliver a notice to the applicant about the product that its renewal is guaranteed but its premium rate is not guaranteed and the content of rate adjustment, and assign staff or a dedicated person to explain to the applicant by phone. However explanation by phone is not required when the insurance enterprise or its sales channel partner sells a new contract or has explained to the applicant after underwriting the policy that the product’s renewal is guaranteed but its premium rate is not guaranteed with proof of such action saved.
The content of rate adjustment mentioned in the preceding paragraph includes the new premium rate, reasons for rate adjustment, the time at which premium will be charged based on the new rate, and how it will be handled if the applicant has objection to the rate adjustment.
When an insurance enterprise increases the renewal premium rate of a guaranteed renewable personal health insurance product, its audit unit shall check and confirm whether the rate adjustment related provisions under the preceding four paragraphs are rigorously implemented and its chief auditor shall issue a statement to the effect before the premium rate is adjusted.

An insurance enterprise complying with certain conditions may apply to the competent authority prior to the end of June or the end of December each year for recognition of such compliance and thereafter switch to the use-and-file procedure for launching the insurance products listed in Article 16, paragraph 1, subparagraph 2 or Article 17, paragraph 1, subparagraphs 2 and 3 herein.
The "certain conditions" in the preceding paragraph that apply to insurance products listed in Article 16, paragraph 1, subparagraph 2 or Article 17, paragraph 1, subparagraph 3 are the following:
1. The enterprise's ratio of equity capital to risk-based capital for the past year is at least 1.25 times the statutory standard of adequate capital as specified in Subparagraph 1, Paragraph 2, Article 143-4 of the Insurance Act.
2. The enterprise has not been subject to a major sanction or penalty imposed by the competent authority, or been disciplined by the competent authority for violation of rules for submission of insurance products for review within the past year.
3. The enterprise has not been subject to an administrative fine of more than NT$1 million was imposed by the competent authority within the past year for violation of the Compulsory Automobile Liability Insurance Act.
4. In the case of a non-life insurer, the enterprise's combined ratio over the past year for retained business, not including compulsory automobile liability insurance, was 90 percent or lower. In the case of a life insurer, the enterprise’s 25-month persistency rate for basic insured amounts over the past year was 80 percent or higher.
5. The enterprise was ranked in the top thirty percent in terms of the results of the Treating Customer Fairly Principle evaluation of non-life or life insurance companies in the past year.
6. Professionally licensed signatories employed on a full-time basis accounted for 75 percent or higher of all actual signatories for insurance products submitted for review during the past year.
7. The insurer has launched an insurance product during the past year designed specifically to dovetail with government policy needs, or has taken part in public service work during the past year, and in either case has performed with distinction.
The "certain conditions" in paragraph 1 hereof that apply to insurance products listed in Article 17, paragraph 1, subparagraphs 2 are the following:
1. Certain conditions set out in the preceding paragraph 2 hereof; and
2. The enterprise’s chief risk officer and its internal risk model are rated class 1 for the levy rates of Life Insurance Guaranty Fund for the last year.
Major sanctions and penalties referred to in paragraph 2, subparagraph 2 mean major sanctions and penalties specified in Article 2 of the Regulations Governing Public Announcement by the Financial Supervisory Commission of Material Sanctions for Violations of Financial Legislation.
The competent authority shall define the meaning of "professionally licensed signatories" as used in subparagraph 6 of paragraph 2.
The recognition referred to in paragraph 1 remains valid for a period of six months. However if an insurance enterprise falls out of compliance with subparagraph 1, 2, or 6 of paragraph 2 during the recognition period, insurance products listed in paragraph 1 herein shall still be subject to review on a prior-approval basis.
For the sale of insurance products listed in paragraph 3 herein that are switched to the use-and-file procedure, an insurance enterprise shall obtain the consent of its board of directors or board of executive directors; for the branch of a foreign insurance enterprise in Taiwan, the sale of such products shall have the consent of its responsible person in Taiwan.

A life insurance enterprise whose income from insurance premiums of new contracts for protection-type insurance products and elderly insurance products as a proportion of its income from insurance premiums of new contracts for all products ranks among the top twenty percent of insurance enterprises in the most recent year may, before the end of February each year, apply to the competent authority for recognition. The procedures for processing insurance products listed in Article 17, paragraph 1, subparagraph 3 may be changed to the use-and-file procedure and the recognition shall be valid for one year.
Where the life insurance enterprise whose income from insurance premiums of new contracts for protection-type insurance products and elderly insurance products as a proportion of its income from insurance premiums of new contracts for all products ranks among the bottom five percent of insurance enterprises in the most recent year and the proportion has decreased from the previous year, the procedures for processing insurance products applicable for the use-and-file procedure within the one-year period after the notice from the competent authority in accordance with Article 15, paragraph 1, subparagraph 2 shall be changed to the prior-approval procedure. However, this rule does not apply to protection-type insurance products and elderly insurance products or insurance products amended in accordance with related regulations.
Where the life insurance enterprise engaging in the National Insurance Coverage Improvement Plan, microinsurance, or investment in 5+2 Industrial Innovation Plan in the most recent year, and meets certain performance criteria, the competent authority may, before the end of March each year, approve the conversion of a certain number of insurance products specified in Article 17, paragraph 1, subparagraph 3 and submitted by the life insurance enterprise for review to the use-and-file procedure. The effective period of the approval shall be one year. However, this rule does not apply if the conditions specified in the preceding paragraph have occurred in the most recent year.

An insurance enterprise may sell a given insurance product only if, during the preparation period prior to sale of the insurance product, it has convened a meeting of its insurance product management team to check the following matters:
1. Disclosure of product information.
2. Uploading actuarial data to a computer network and verifying its accuracy.
3. Risk management mechanisms and reinsurance arrangements.
4. Set-up and testing of information systems.
5. Printing of policy provisions, proposals, rate tables, and brochures.
6. Training, including circulating among its solicitors and sales channel partners whether certain insurance products are suitable for selling to customers over 65 years of age, and characteristics of targets and customers for whom certain products are not suitable.
An insurance enterprise shall, based on the results of evaluation under Subparagraph 7 of Article 6 herein, examine item-by-item to confirm that matters stated under the subparagraphs of the preceding paragraph are consistent with the results of evaluation.

When an insurance enterprise convenes a meeting of the insurance product management team, it shall keep minutes recording its proceedings and conclusions. The minutes shall be submitted to the general manager for review, and kept available for inspection by the competent authority.
The vice general manager (or someone of equivalent rank) shall serve as chairperson of the insurance product management team referred to in the preceding paragraph.

After sales of an insurance product have commenced, the insurance enterprise shall convene meetings of its insurance product management team at least once every half a year to review the following product-related matters and take responding measures, and shall make any necessary adjustments and amendments:
1.Compliance with applicable acts or regulations.
2.Safeguarding of consumer interests, including re-examining past policyholder dispute cases and evaluating whether an insurance product involved had adverse effect on the rights and interests of customers over 65 years of age, whether the product suitability policy was followed or the fair treatment of customers principle was violated.
3.Business strategy, and any potential threat to current or future solvency.
4.Appropriateness of asset-liability allocation, and the implementation of the asset allocation scheme for life insurance products with insurance period over one year.
5.Analysis of the pricing reasonableness of insurance products, which shall include the adequacy of the expense loading rate. An analysis of the reasonableness of the pricing of the life insurance product must be conducted in accordance with the methodology specified by the competent authority. Where the rate becomes inadequate due to the deterioration of actual incidence rate, or the premium rate tends to be high due to an improvement of the actual incidence rate, the insurance enterprise shall formulate specific response measures.
6.Analysis of the concentration risk of various types of products and response measures.
7.The deviations as considered by the competent authority to be significant between the actuarial assumption for review (including the lapse rate and the new money rate) and the actual after-sale experience in respect of the major life insurance products.
8. Implementation status of the review and adjustment plans for the automobile insurance (excluding compulsory automobile liability insurance) and fire insurance product rates, and the rate adjustment review period may not exceed five years.
9. Establishment of statistics of non-life insurance products and the review and adjustment of rates.
10. Tracking the sales amount of insurance products; where an early warning or sales limit is reached, the insurance enterprise must propose the evaluation and analysis for whether sales shall be continued.
11. Analysis of the effectiveness of the reinsurance for insurance products; where the effectiveness is not shown after the sales of such products, the insurance enterprise shall formulate specific response measures.
12. Other items as required by the competent authority.
When the sales amount of insurance products reaches the early warning level or sales limit, the insurance enterprise shall promptly convene a meeting of its insurance product management team to discuss response measures to be adopted.
Actions taken in accordance with the meetings of the insurance product management team under the preceding two paragraphs shall be submitted to the upcoming meeting of the board of directors.
The insurance enterprise shall submit to the board of directors an overall assessment of the impact of the sale of insurance products on the Company's finance, business, and solvency on a regular basis each year.

Where it is necessary to amend an insurance product in order to coordinate with changes to applicable acts or regulations, within 45 working days from the day on which the amendment to the applicable acts or regulation was issued and took effect an insurance enterprise shall, unless otherwise provided by act or regulation, amend the insurance product and complete transmission thereof to an insurance product database established by the competent authority or by an institution of its designation, without observing provisions regarding the procedures for partial insurance product modification as set out in Article 20.

(deleted)

The competent authority may establish different insurance product review committees for different types of insurance products to review the insurance products submitted by insurance enterprises for review, and may as necessary designate [product review] to a specialized institution.

When an insurance enterprise accepts an invitation to attend (or observe) an insurance product review meeting convened by the competent authority or by a specialized institution authorized thereby, the enterprise shall dispatch at least one person of manager rank or higher with a thorough understanding of the product to attend (or observe) the meeting as the enterprise's representative.
Persons who attend (or observe) a review meeting shall carefully read meeting materials beforehand, and after the review meeting shall submit to the insurance product evaluation team a written report regarding any material controversies and the main conclusions. They shall also submit their reports to the general manager for review.

Where any one of the following situations applies with respect to an insurance enterprise, the competent authority may, depending on the severity of the circumstances, prohibit the insurance enterprise for a period of one year or less from filing for prior approval or use-and-file launch of an insurance product in accordance with Article 15, paragraph 1 herein and make public announcement of the same, provided, however, that this does not apply where an insurance product has been amended in order to coordinate with changes to applicable acts or regulations, or where the competent authority has granted approval.
1. The enterprise has continued selling an insurance product after being ordered by the competent authority to suspend sales.
2. A signatory has continued to act as signatory after being disqualified by the competent authority.
3. Three times or more within the past year, the competent authority has determined that the circumstances set out in any one of the subparagraphs under paragraph 1 of Article 30 obtain with respect to the enterprise's insurance products, provided, however, that this does not apply to a minor violation of Article 30, paragraph 1, subparagraph 7 if the competent authority has dealt with the matter in accordance with Article 30, paragraph 3.
4. Within the past year, the competent authority has assessed a cumulative total of 10 or more violation points for insurance products that the insurance enterprise's signatories have signed off on in behalf of that insurance enterprise.

When any one of the following circumstances applies with respect to an insurance product of an insurance enterprise, the competent authority may reject the product outright without proceeding to a review, or may order the insurance enterprise to suspend sales and make public announcement of the same except for circumstances specified in subparagraphs 10 to 12 hereof:
1. The product is not compliant with applicable legal requirements in a material manner.
2. The product has not been signed by the general manager, a department head authorized thereby, or a qualified signatory.
3. The product contains a material error, or is missing an important provision.
4. Materials submitted for review purposes contain false representations.
5. The general manager, a department head authorized thereby, or a qualified signatory makes a false or materially erroneous statement.
6. The enterprise commences product sales without observing the provisions of Article 15, paragraph 1 or Article 20, paragraph 1.
7. The product was not submitted under the required review process.
8. The enterprise has failed to submit a document as required under Article 18, paragraph 2, or a submitted document is incomplete and the enterprise is ordered to make correction within a prescribed time period but fails to do so.
9. The enterprise fails in a material manner to observe the provisions of Article 5, Article 8, paragraph 1, subparagraph 1 or paragraph 2, Article 9, paragraph 1, subparagraph 1, Article 21, paragraph 6, Article 22, Article 23, Article 25, or Article 28.
10. An enterprise applies in accordance with Article 15, paragraph 2 with the competent authority for prior approval of an insurance product and the competent authority issues a letter requiring supplementation of the filing documents, but supplementation is not made within 65 working days from the day on which the competent authority received in full all application documents.
11. An enterprise applies in accordance with Article 15, paragraph 3 with the competent authority for prior approval of an insurance product and the competent authority issues a letter requiring supplementation of the filing documents, but supplementation is not made within 35 working days from the day on which the competent authority received in full all application documents.
12. An enterprise who has received more than three rejections from the competent authority for the same product filed for prior-approval in accordance with Article 15, paragraph 2 or paragraph 3.
Where the situation set out in subparagraph 6 of the preceding paragraph applies with respect to an insurance product, the competent authority may impose sanction in accordance with Article 171 of the Insurance Act.
Where the situation set out in paragraph 1, subparagraph 7 applies with respect to an insurance product and the competent authority has determined that the violation is minor, the competent authority may order the insurance enterprise to submit the product under a different review procedure, and may also order it to suspend sales of the insurance product in question until it has completed procedures for resubmission of the product for review.

Where any one of the following situations applies with respect to an item for which a signatory bears responsibility pursuant to the provisions of Article 13, the competent authority may, depending on the severity of the circumstances, assess from one to three violation points and disclose same to insurance enterprises for a period of three years:
1. The content on which the signatory has signed off is not compliant with applicable legal requirements in a material manner.
2. Submitted material, or the format thereof, is materially non-compliant with requirements.
3. The product contains a material error, or is missing an important provision.
4. Materials submitted for review purposes contain false representations.
5. A false or materially erroneous statement is made.
6. The content on which a signatory has signed off is in material violation of directions for insurance product review adopted by the competent authority.
7. The content on which a signatory has signed off is not compliant in a material manner with the best practice principles and self-regulatory rules or codes of professional conduct adopted by domestic professional societies (associations) designated or authorized by the competent authority, or by other relevant entities, to which the signatory belongs.
Where there are a large number of errors or clear defects within a prescribed time period in the matters signed off on by an insurance product signatory, the competent authority may, depending on the severity of the circumstances, assess from one to three violation points and disclose same to insurance enterprises for a period of three years.
If an insurance product signatory has been assessed a cumulative total of three violation points by the competent authority within the past three years, the competent authority may prohibit the signatory from signing off on insurance products for six months and make public announcement of the same.
Where a domestic professional society (association) designated or authorized by the competent authority, or another relevant entity, to which the signatory belongs, has suspended or restricted the signatory's membership status due the situation set out in paragraph 1, subparagraph 7, the competent authority may, depending on the severity of the circumstances, prohibit the signatory for a period of one year or less from signing off on insurance products.

These Regulations shall be implemented from the date of promulgation except that Article 24 amended and promulgated on November 8, 2017 shall be implemented from 1 January 2018 and Article 17, paragraph 1, subparagraph 4 and Article 21-1, paragraph 2 amended on March 30, 2020 shall be implemented on January 1, 2021, and Article 6, Article 22 and Article 24, paragraph 1, subparagraph 2 amended on March 29, 2022 shall be implemented on October 1, 2022, and Article 4, Article 7, Article 8, Article 9, Article 11, Article 12, Article 13, Article 17, Article 24, and Article 29 amended on December 18, 2023 shall be implemented on July 1, 2024, and Article 24 amended on June 26, 2024 shall be implemented on July 1.