Any person who manufactures or imports the defective medical devices set forth in Subparagraph 1 of Article 8 shall be subject to imprisonment for not more than five years, detention, or in addition thereto a fine of not more than NT$50,000,000.
Any person who knowingly sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the defective medical devices set forth in the preceding paragraph shall be subject to imprisonment for not more than three years, detention, or in addition thereto a fine of not more than NT$10,000,000.
Any person who commits the aforementioned offence set forth in Paragraph 1 by negligence shall be subject to imprisonment for not more than three years, detention, or in addition thereto a fine of not more than NT$10,000,000.
Any person who commits the aforementioned offence set forth in Paragraph 2 by negligence shall be subject to detention or a fine of not more than NT$1,000,000.

Any person who uses, without authorization or as an infringement, the name, instructions, or labels of another legal medical device shall be subject to imprisonment for not more than five years, detention, or in addition thereto a fine of not more than NT$20,000,000.
Any person who knowingly imports, sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the medical devices set forth in the preceding paragraph shall be subject to imprisonment for not more than two years, detention, or in addition thereto a fine of not more than NT$10,000,000.

Any person who violates Paragraph 1 of Article 25 and manufactures or imports medical devices without approval, or who violates Paragraph 2 of Article 25 and applies for listing instead of the required registration and market approval shall be subject to imprisonment for not more than three years, detention, or in addition thereto a fine of not more than NT$10,000,000.
This shall also apply to any person who knowingly sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the medical devices set forth in the preceding paragraph.

In the event that the representative of a legal entity, or an agent, employee, or any other personnel of a legal entity or a natural person commits any of the offences set forth in Article 60 through the preceding article while performing his/her duty, the offender shall be punished in accordance with the provisions of all of the articles. Moreover, the said legal entity or natural person shall also be subject to up to ten times of the fine as set forth in all of the articles.

Any person who manufactures or imports the defective medical devices set forth in Subparagraphs 2 through 5 of Article 8 shall be subject to a fine of not less than NT$60,000 but not more than NT$50,000,000.
Any person who sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the defective medical devices set forth in the preceding paragraph shall be subject to a fine of not less than NT$30,000 but not more than NT$20,000,000.

Any person violating the provisions of Article 46 and labeling or promoting non-medical devices as having therapeutic effects shall be subject to a fine of not less than NT$600,000 but not more than NT$25,000,000.
A fine of not less than NT$200,000 but not more than NT$5,000,000 shall be imposed when any of the following circumstances occurs:
1. Violating the provisions of Article 40 and engaging in advertising of medical devices without being a medical device firm.
2. Violating the provisions of Paragraph 1 of Article 41 and failing to apply for approval or forward approval documents to mass media enterprises for verification before publishing or broadcasting a medical device advertisement.
3. Violating the provisions of Paragraph 2 of Article 41 and modifying or altering the originally approved contents of a medical device advertisement without approval.
4. Violating the restrictions on the extent of publishing or broadcasting medical device advertisements specified in Article 44.
5. Where medical devices are advertised in any of the manners set forth in the provisions of Article 45.
6. Where a medical device firm fails to give a notice or recall medical devices within the specified time period under any of the circumstances set forth in Subparagraphs 1 through 3 of Paragraph 1 of Article 58.

Any mass media enterprise which violates the provisions of Paragraph 1 of Article 42 governing the publishing or broadcasting of advertisements shall be subject to a fine of not less than NT$200,000 but not more than NT$5,000,000, and shall be ordered to stop publishing or broadcasting the advertisements. For those who fail to stop publishing or broadcasting, a consecutive sentence shall be imposed for each violation until the said advertisements are no longer published or broadcast.
Any mass media enterprise which violates the provisions of Paragraph 2 of Article 42 and fails to preserve the information of the firm that commissions the advertisement, or evades, impedes, or refuses any request by the competent authority for such materials shall be subject to a fine of not less than NT$60,000 but not more than NT$300,000. A consecutive sentence shall also be imposed for each violation.
When imposing the disciplinary actions set forth in Paragraph 1, the municipal or county (city) competent authority shall notify the local competent authority or the competent authority of the target business for handling in accordance with applicable regulations.

In the case of violation of the provisions of Chapter V of this Act, punishments shall be imposed in accordance with the provisions of this chapter, and the name of the offender, name of the medical device, and circumstances of committing the violation may be announced. In addition, the following disciplinary actions shall be imposed according to the severity of the violation:
1. Cancelling the medical device license or listing, and forbidding applications to use the original product name for a period of two years.
2. Ordering the offender to publish or broadcast corrected advertisements or commercials containing an apology and excluding wrong messages in the same size and time slots in the original publications or on the original channels for a certain number of times within 30 days upon receipt of the notification of punishment. Any business that fails to publish or broadcast corrected advertisements or commercials shall be subject to a fine of not less than NT$120,000 but not more than NT$600,000. Moreover, the approval that the business has obtained for all of the medical device advertisements shall be cancelled, and no advertisement applications shall be accepted within two years.
In the case of repeated violation after a punishment is imposed in accordance with the preceding paragraph, an order may be issued to terminate the business of the offender and cancel its company, business, or factory registration or part of the registered particulars.

A fine of not less than NT$60,000 but not more than NT$2,000,000 shall be imposed when any of the following circumstances occurs:
1. Violating the provisions of Article 17 by purchasing or renting medical devices that have not been registered and approved or listed, or medical devices supplied by those other than medical device firms.
2. Violating the provisions of Paragraph 1 of Article 20 by failing to meet the Establishment Standards for Medical Device Manufacturers.
3. Where domestic medical device manufacturers violating the provisions of Paragraph 1 of Article 22 by failing to comply with the medical device quality management system regulations, or violating the provisions of Paragraph 2 of Article 22 by manufacturing medical devices without obtaining manufacturing license.
4. Where medical device dealers importing medical devices that have been manufactured in violation of the provisions of Paragraph 3 of Article 22 as applied mutatis mutandis pursuant to Paragraph 1 or Paragraph 2.
5. Violating the provisions of Paragraph 1 of Article 25 by manufacturing or importing medical devices without applying for registration and market approval or listing, or violating the provisions of Paragraph 2 of Article 25 by applying for listing instead of the required registration and market approval.
6. Violating the provisions of Paragraph 3 of Article 34 by selling domestically the medical devices that are for export only.
When the circumstances set forth in Subparagraph 3 or 4 of the preceding paragraph occur, in addition to the punishments that shall be imposed in accordance with the preceding paragraph, the central competent authority may publicize the names of the medical device firms and order them to make corrections within a time period, during which their manufacture, import, and business operations may be suspended in part or in whole. If no corrections are made within the time period, extension of medical device license in accordance with Article 27 shall not be approved or annual declaration in accordance with Article 28 shall not be filed, and any new applications for registration and market approval or listing of other medical devices of the manufacturers shall not be accepted. In the case of serious violation, the central competent authority may also cancel all or part of the medical device manufacturing licenses, licenses, or listings.

In case a medical device firm uses false documents or information to file applications in accordance with the provisions of this Act, a fine of not less than NT$60,000 but not more than NT$2,000,000 shall be imposed. In the case of serious violation, no application shall be allowed within two years. The licenses or approvals that have been obtained shall be cancelled.

A fine of not less than NT$30,000 but not more than NT$1,000,000 shall be imposed when any of the following circumstances occurs:
1. Violating the provisions of Paragraph 1 of Article 13 by engaging in the business activities of medical device firms without being a medical device firm, or violating the provisions of Paragraph 2 of Article 13 by failing to complete change registration for any change in the particulars registered.
2. Violating the provisions of Paragraph 3 of Article 13 by failing to complete medical device firm registration or failing to manufacture, sell, or supply medical devices at the registered place.
3. Violating the limitations announced in accordance with Article 18.
4. Violating the provisions of the regulations established in accordance with Paragraph 4 of Article 22 in regard to alteration.
5. Violating the provisions of Paragraph 1 of Article 23 by authorizing the commissioning or accepting the commissioning to manufacture medical devices without approval, or violating the provisions of Paragraph 2 of Article 23 by manufacturing medical devices.
6. Violating the provisions of Paragraph 1 of Article 24 by failing to comply with the regulations for good distribution practice of medical devices, or violating the provisions of Paragraph 2 of Article 24 by engaging in wholesale, import, or export of medical devices without obtaining a distribution license.
7. Violating the provisions of Paragraph 1 of Article 25 by selling, supplying, transporting, storing, engaging in brokerage of, transferring, or displaying with the intent to sell medical devices without applying for registration and market approval or listing.
8. Violating the provisions of Article 26 by making alteration to any of the original particulars of registration and market approval or listing without approval.
9. Violating the provisions of Article 32 or 33 in regard to the packaging, labels, and instructions of medical devices or the particulars indicated thereof.
10. Violating the provisions of the regulations established in accordance with Paragraph 2 of Article 35 in regard to restrictions on supply and sale or return.
11. Violating the provisions of Paragraph 1 of Article 37 by implementing a clinical trial without approval, or violating the provisions of Paragraph 2 of Article 37 by failing to obtain consent from human subjects prior to implementing the clinical trial.
12. Violating the provisions of Paragraph 1 of Article 48 by failing to report to the central competent authority, or violating the provisions of Paragraph 2 of Article 48 in regard to the conditions, reporting methods, time period, and contents.
13. Violating the provisions of Article 51 by evading, impeding, or refusing an inspection or random testing.
When the circumstances set forth in Subparagraph 6 of the preceding paragraph occur, in addition to the punishments that shall be imposed in accordance with the preceding paragraph, the central competent authority may publicize the names of the medical device firms and order them to make corrections within a time period, during which their wholesale, retail, import, and export may be suspended in part or in whole. For those who fail to make corrections within the time period, a consecutive sentence may be imposed for each violation until the corrections are made.

A fine of not less than NT$20,000 but not more than NT$500,000 shall be imposed when any of the following circumstances occurs:
1. Where a medical device firm manufactures or imports the defective medical devices set forth in Subparagraph 6 of Article 8 and commits a serious violation, or fails to make corrections within the time period that has been ordered by the competent authority in accordance with Paragraph 2 of Article 57.
2. Violating the provisions of Paragraph 1 of Article 15 by failing to employ qualified technicians.
3. Violating the provisions of Paragraph 1 or 2 of Article 19, or violating the provisions of the regulations established in accordance with Paragraph 3 of Article 19 in regard to the scope, methods for establishment and maintenance of data, retention period, report contents and methods.
4. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 24 in regard to alteration.
5. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 37 in regard to avoidance of conflicts of interest, information disclosure, supervision and administration, or inspection, or failing to make corrections within the time period that has been ordered by the competent authority in accordance with the provisions of the said regulations.
6. Violating the provisions of Article 38 by failing to report or report for recordation, or failing to report or report for recordation within a time period.
7. Violating the provisions of Article 49 by failing to conduct reporting or undertake corrective and preventive measures in accordance with the provisions.
8. Violating the provisions of Article 53 by evading, impeding, or refusing a census.
9. Violating the provisions of Paragraph 3 of Article 55 by failing to withdraw or suspend the manufacture, import, or sale.
10. Failing to give recall notices or recall medical devices within a specified time period when any of the circumstances set forth in Subparagraphs 4 through 6 of Paragraph 1 of Article 58 occurs.
11. Violating the provisions of Paragraph 2 of Article 58 by failing to cooperate in recalling medical devices.
12. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 58 in regard to the approaches for recall operation and handling methods of medical devices.

In case a person fined under this Act disagrees with the fine imposed in accordance with the provisions of this Act, he/she may, within fifteen days upon the receipt of the punishment notice, file a written objection requesting a review. However, no more than one objection shall be filed.
The authority imposing the fine shall, within fifteen days upon receipt of the written objection set forth in the preceding paragraph, review the case, and shall alter or cancel the original punishment if it deems the objection justifiable.
If the person fined disagrees with the result of the review set forth in the preceding paragraph, he/she may file an administrative appeal and initiate an administrative proceeding in accordance with applicable laws.

In the event that approval is not given to the application for medical device clinical trial implementation, medical device registration and market approval, or change or extension of a license filed in accordance with this Act, the disagreeing applicant may, within four months upon receipt of the notice of disciplinary action, clearly state the reasons and apply for re-examination. However, only one application for re-examination is allowed.
The central competent authority shall alter or cancel the original disciplinary action if it deems that the application for re-examination set forth in the preceding paragraph is justifiable.
If the person applying for re-examination does not agree with the decision made regarding the re-examination, he/she may file an administrative appeal and initiate an administrative proceeding in accordance with applicable laws.

Unless otherwise provided, the punishments prescribed in this Act shall be imposed by the municipal or county (city) competent authority, or may be imposed by the central competent authority if necessary. However, the cancellation of the company registration, business registration, factory registration, or the registered particulars, in part or in whole, upon confirmation of the order of business termination by the municipal or county (city) competent authority, shall be forwarded for execution by the industry or commerce competent authority or its competent authority of the target business.