These Regulations are established in accordance with Paragraph 4 of Article 7 of the Occupational Safety and Health Act (the Act).
Machinery, equipment or tools (hereinafter referred to as the products) specified in Paragraph 1 of Article 7 as designated by the central competent authority shall be exempted from registration under any of the following circumstances:
1. Where they are subject to requirements for inspection, certification, approval or management in accordance with other laws or acts;
2. Where they are used for national defense or military purpose, and supported by documents issued by the Ministry of Defense or its directly subordinate agencies;
3. Where they are specialized model manufactured in limited amount or imported for purpose of scientific research or testing, provided that approval is granted by the central competent authority;
4. Where they are commercial samples or exhibition articles not intended for use or operation, provided that approval is granted by the central competent authority;
5. Where they are imported for purpose of re-exported with or without further processing or assembly, provided that approval is granted by the central competent authority; or
6. Other special circumstances where exempted from registration is necessary, provided that approval is granted by the central competent authority.
Where a manufacture or an importer (hereinafter referred to as the applicant) considers that the products, mentioned in the preceding Article, manufactured, produced, processed or modified (hereinafter referred to as manufactured) domestically or imported from foreign countries comply with safety standards specified by the central competent authority in terms of their structure, performance and safeguards, they shall register the safety information of these products at the Information Reporting Website (hereinafter referred to as the Information Website) specified by the central competent authority and complete self declaration (hereinafter referred to as safety-declared products).
The applicant that declares compliance of its products with safety standards in accordance with Paragraph 3, Article 7 of the Act shall take any one of the following approaches to demonstrating compliance by transmitting related test reports through the Internet and maintaining them for checks.
1. To obtain type verification from verification bodies recognized by the central competent authority;
2. To obtain certification from product certification bodies accredited by domestic or foreign accreditation bodies; or
3. To complete self-inspection and self-check of production consistency to ensure compliance with the safety standards.
For luminaires, motors and switch boxes used in explosive atmosphere, power press or shearing machinery, woodworking circular saws and grinding machinery the approach to demonstrating compliance will be limited to subparagraph 1 of the preceding paragraph.
The following requirements shall apply if the approach stated in Subparagraph 3 of Paragraph 1 is taken:
1. Self-inspection shall be performed by testing laboratories accredited by accreditation bodies,
2. Self-check of production consistency shall be performed by bodies accredited by accreditation bodies; and
3. The qualification of testing personnel of testing laboratories shall comply with criteria specified in Attaching table 1.
For registration of a single article, the self-check of production consistency is waived if the approach of Subparagraph 3 of Paragraph 1 is taken.
The following documents shall be affixed with the stamp seals of the applicant and the responsible person when the declaration of safety is made, and shall be uploaded to the Information Website by following the electronic format specified by the central competent authority.
1. Declaration of conformity: a document signed to declare compliance with safety standards.
2. Registration documents: factory registration, company registration, business registration or other equivalent documents that demonstrate official approval for establishment of the factory, company or business, except where registration is not required by laws or the registration information has already uploaded onto the Information Website without changes.
3. Testing documents specified below that demonstrate compliance with safety standards and are valid for more than 3 months. Where registration is sought for a single article, the validity period of testing documents is not of concern and the certification of production consistency is not required.
(1) type verification certificate, certification certificates or self-inspection/self-test reports; and
(2) certificate of production consistency.
4. Basic information about the products:
(1) Description of the product type, including catalog, product name, illustration of the appearance of the product, product classification code (HS code or CCC code), specification of the main processing unit and control unit, etc. Where it is not possible to identify the type of a product by its type number, a determination of same type description may be used.
(2) Instructions of the installation, operation, maintenance and repair of the product and recommended practices for responding to hazards, including illustration of the location of the product safety devices and their functions.
5. Information about the product safety devices and accessories:
(1) brand name, specifications, descriptions of the safety structure, performance and protection, compliance; and
(2) certification or test reports for critical components and relevant strength calculations. Where the products are single articles to be sold after further processing or repairmen and it is difficult to obtain relevant documents, other testing documents that can demonstrate compliance of the article can be provided instead.
6. Other conformity assessment procedure documents or technical files required by the central competent authority.
Where the import of the products is restricted due to border control measures, the importer may apply to the central competent authority for prior-release under one of the following circumstances:
1. an application has been made to the verification body, certification body or testing laboratories accredited by accreditation bodies for performing testing against the safety standards and the certificate is not issued yet, or
2. other special situations where prior release of the product is necessary and approval is obtained from the central competent authority.
The relevant provisions specified in the Regulations Governing the Application for Prior Release of Mechanical Products shall apply mutatis mutandis to the application, follow-up, check and surveillance of prior release mentioned in the preceding paragraph.
Where the import of the products meeting the conditions specified in Article 2 is restricted due to border control measures and removal of the restriction is necessary, the importer shall prepare a declaration of intended uses of the products and apply to the central competent authority for exempting from registration and obtaining a unique customs clearance code, which shall be filled out in the declaration of importation.
Where the customs clearance code is obtained via deceptive and fraudulent means, the central competent authority shall withdraw that code and reject subsequent applications for customs clearance code made by the importer for 1 to 3 years depending on the severity of the conditions. Where criminal sanction is involved, the case shall be forwarded to judicial courts for processing.
Where the products are not used in accordance with the declared intended uses specified in Paragraph 1 for applying for the customs clearance code, the central competent authority shall rescind the code and reject subsequent applications for customs clearance code made by the importer for 6 months.
The relevant provisions specified in the Regulations Governing Exemption from Certification for Mechanical Products shall apply mutatis mutandis to the application, follow-up, checking and surveillance of cases involving exemption from registration mentioned in Paragraph 1.
For those that do not comply with the registration requirements mentioned in the Article 5, the central competent authority may request corrective actions be taken by the applicant within a certain time limit. Where the corrective actions are not taken, the application shall be denied.
The total time period for correction mentioned in the preceding paragraph shall not exceed 60 days, except for special cases approved by the central competent authority.
The applicant are required to use digital certificate that can demonstrate his identity to register the safety information on the Internet.
Where there are more than 2 agents listed in the application form to register safety information mentioned in Paragraph 3, Article 7 of the Act, each agent may perform the registration obligation on behalf of the responsible applicant.
The applicant shall designate a responsible person to take care of registration of safety information and subsequent updates.
Where changes are made to the content of registered information, an application of modification shall be made within 30 days upon the date of changes made.
When the application for modification is made in accordance with the preceding Paragraph, the requirements for uploading documents to the Information Website mentioned in Article 5 of these Regulations shall apply. The testing documents specified in Subparagraph 3 of Article 5 may be replaced by supporting documents with a validity period of not less than 30 days.
For products that the manufacturer declares compliance with safety standards, control measures shall be taken during the production processes to ensure that products of the same type conform to the content stated in the technical file and have the same safety specifications as the tested samples in test reports.
For products already registered at the Information Website, the applicant shall ensure that the products comply with the content of declaration. Where the content of the registered information is changed, the applicant shall state the reasons and re-apply for registration so as to ensure compliance.
The applicant shall maintain the declaration of conformity and related technical files for the registered products for a period of not less than 10 years after the products are no longer manufactured.
Registered information that are confidential or access-restricted may not made available to the public. The central competent authority may make available to the public information that is properly screened through the following methods.
1. To responded to inquiries or allow for download on the Internet; or
2. To provide reproduction or copies of the information.
Provision of the information by responding to inquiries or allowing for download as mentioned in the preceding paragraph shall be free of charge. Provision of the information by reproducting or making copies will involve a service charge at a rate stipulated by the central competent authority. Where authorization is granted to download a limited range of information from the Internet, the service charge may be exempted.
The documents attached to the registered information shall be written in Chinese, and may be supplemented with information in English or other languages.
Where the documents mentioned in the preceding paragraph are written in English, technical documents to be used by workers for installation, operation, maintenance, repair of the product or taking recommended practices for responding to hazards shall have translations in traditional Chinese. Documents that are written in languages other than English shall have English translations for reference.
The central competent authority may request the applicant failing to comply with the preceding two paragraphs to take corrective actions within a certain time limit. If corrective actions are not taken after the time limit, the application shall be denied.
When the applicant completes registration of safety information, the central competent authority shall assign a registration number and issue a registration-completed notice.
The registration-completed notice mentioned in the preceding paragraph shall contain the information about the applicant, basic data of the product, product specifications, information about the production premises, references to safety standards, registration number, registration date, period of validity and information that is considered necessary.
The period of validity mentioned in the preceding paragraphs shall be stipulated by the central competent authority ranging from 3 years to 7years, depending on the categories of products. The registration shall become invalid when the testing or certification documents provided by the applicant expire.
Where the name of importer is different from that of the person that completes registration of safety declaration of the products, the importer may, under the authorization of that person, apply to the central competent authority for authorized prior release notice for purpose of clearing customs.
The scope of authorized prior release notice mentioned in the preceding paragraph may cover all types stated in the registration notice.
The central competent authority shall rescind the authorized prior release notice mentioned in Paragraph 1 upon receipt of notice from the person that completes registration of safety declaration of the product for termination of authorization. The same shall apply when the registration at the Information Website is withdrawn or rescinded.
Under any of the following circumstances, the applicant shall re-apply for registration of registered products within 30 days from the date when the situations occur:
1. Where the revision of safety standards results in noncompliance of the registered information; or
2. Where modification of the design of registered products results in the need to update the registered information.
The applicant may uploading the documents to the Information Website in accordance with the provisions of Article 5 within three months prior to the expiry date of the validity period of product registration in order to apply for extension of the term of validity. The testing documents specified in Subparagraph 3 of Article 5 may be replaced by supporting documents with a validity period of not less than 30 days.
A new application for registration shall be made if the application for extension is made after the registration period expires.
The same applicant shall not make applications for the same type of products again, except where the application is required to be made again in accordance with the preceding Article.
The applicant shall use the type/model given by the manufacturer as that of the product to be registered. Where there is no such information, the type may be determined by a combination of specifications, characters or codes.
The type/model, specifications, characters or codes mentioned in the preceding paragraph shall be distinctive and determined by the applicant at the time for making applications for information registration.
The names of products that have been declared safe shall
1. not use the product brand of others or the name of the manufacturer, except when the use of such information is authorized,
2. not be identical to the product name safety-declared by other manufacturer, or raise a concern on counterfeit, hint or insinuation,
3. not be fraudulent, exaggerating or creating inadequate association or confusion regarding the safety performance of safety-declared products,
4. not mix foreign languages or numbers, except taking the direct meaning, and
5. not have situations where it is not proper to be the name of safety-declared product.
Where the names of safety-declared products are identical or similar, they shall be verified by the central competent authority in priorities of brand, name of manufacturer or other names that can be used for identification.
Where registered safety-declared products are found to be not in compliance with paragraph 1, in addition to the legal responsibilities involved, the central competent authority may request that corrective actions be taken or re-examination be performed.
Information that is uploaded to the Information Website in accordance with Article 5 shall
1. not be the same as the product information concerning specialized technology or patent registered by other manufacturers, except where the information is publicly available or the use of which is authorized,
2. not raise a concern on counterfeit, hint or insinuation,
3. not be fraudulent, exaggerating or creating inadequate association or confusion regarding the safety performance of safety-declared products, or
4. not be adequate for describing the structure, performance and effects of safeguards of safety-declared products.
Where registered safety-declared products are found to be not in compliance with the preceding paragraph, in addition to the legal responsibilities involved, the central competent authority may request that corrective actions be taken or the uploaded information be re-examined.
For products of which registration is completed, the applicant shall ensure that they conform to the scopes, types and functions contained in the registered information, and the physical features of the products shall not be different from the registered information.
Where it is necessary, the central competent authority shall request the applicant to prepare samples to conduct tests on certain items, sample testing or on-site audits at the production premises.
Under any of the following circumstances, the central competent authority shall cancel the registered product safety information:
1. Where requests are made by the applicant for cancellation,
2. Where the registration documents that the applicant submitted to demonstrate official approval for establishment of the factory, company or business are withdrawn, rescinded or cancelled according to laws,
3. Where the businesses of the applicant are dissolved or closed down, or the recognition of the businesses are withdrawn,
4. Where other significant non-compliances are found by the central competent authority.
Upon cancellation of registered product safety information mentioned in the preceding paragraph, the authorized prior release notice shall be invalid accordingly.
Where the registered information is obtained by fraudulent or deceptive means, the central competent authority shall cancel the registration. Where criminal charges are involved, the cases shall be forwarded to judicial organizations for processing.
Under any of the following circumstances of the registered products, the central competent authority shall rescind their registered product safety information:
1. Where the inspection results of purchased or sampled products do not comply with the safety standards,
2. Where the inspection reports, conformity assessment supporting documents or samples of products are not provided within the notified time limit without good reasons,
3. Where significant hazards or damages occur due to their defects,
4. Where the products do not comply with labelling requirements and corrective actions are not taken within the notified time limit,
5. Where the declaration of conformity and technical files are not maintained for the time period stipulated in Article 11 of these Regulations,
6. Where re-application for registration is not made in accordance with Article 15,
7. Where the type of products violates the provisions of Article 16 or 17, and corrective actions are not taken within the notified time limit,
8. Where the name of products violates the provisions of Paragraph 1, Article18, or the content of registered information violates the provisions of Paragraph 1, Article 19,
9. Where the product is not maintained identical to the content of registered information physically in accordance with Article 20, and corrective actions are not taken within the notified time limit,
10. Where it is publicly announced that the items are no longer required for registering their safety information at the Information Reporting Website, or
11. Other violations that are considered significant against these Regulations.
Where the registration is withdrawn or rescinded due to noncompliance of the products with the registered information, the original application documents shall not be used for application again.
These Regulations shall take effect on January 1, 2015.
The amended articles of these Regulations come into effect on the day of promulgation.
The articles amended and promulgated on September 22, 2017 of these Regulations shall come into effect on October 1, 2017.