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Chapter Law Content

Chapter 2 Type Certification
Article 6
The obligatory applicant shall apply to certification bodies for type certification by completing an application form and providing the following documents:
1.Declaration of Conformity: the declaration that the manufacturer or importer signs to declare conformity of the products to the implementation procedures and standards for type certification.
2.Basic information about the products:
(1)description of the product type, including product catalog, product name, illustration of the appearance, product classification code (HS code or CCC code), specifications of the main processing unit and control unit, etc.,
(2)reasons for products being classified as the same type,
(3)list of the main type and series of the type,
(4)drawings of the construction, including illustration of the location of the product safety devices and their functions,
(5)drawings of the electric, hydraulic or pneumatic circuit, if applicable,
(6)instructions of performance,
(7)instructions of the installation, operation, maintenance and repair of the product, as well as recommended practices for responding to hazards,
(8)list of product safety devices and safety accessories, including the names, specifications, safety performance and compliance status, test reports of critical components and related strength calculations of the devices, and
(9)other technical files required by the central competent authority.
3.Registration documents: factory registration, company registration, business registration or other equivalent documents that demonstrate official approval for establishment, except where registration is not required by laws or relevant information has been registered with no changes.
4.Conformity assessment certificates: conformity assessment certificates issued in accordance with the implementation procedures and standards for type certification. Where approval is obtained from the central competent authority, other certification documents may be used as alternatives to the conformity assessment certificates.
The certification body may notify the obligatory applicant to supply documents within a certain time limit if the application documents do not comply with the requirements. The application shall be denied if the documents are not supplied within the specified time limit.
The certification body may request the obligatory applicant to provide electronic files for related documents mentioned in subparagraph 1 for purpose of digital storage and management.
Where the documents mentioned in subparagraph 1 are provided in copies, the obligatory applicant shall note on the copies that they are identical to the originals and properly signed. The certification body may request that the originals of the documents be provided for check, if necessary.
Article 7
Where a certificate of type certification is withdrawn, or rescinded due to noncompliance of products with safety standards, the conformity assessment documents used to apply for the certificate shall not be used again for purpose of reporting conformity assessment.
Article 8
Certificates of product certification issued by countries that signed bilateral or multilateral mutual recognition agreements with the Republic of China shall be deemed as equivalent to the conformity assessment certificates mentioned in subparagraph 4, paragraph 1, Article 6.
Article 9
The technical files provided by the obligatory applicant 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 foreign languages other than English shall have English translations for reference.
The certification body may request that the obligatory applicant failing to comply with the preceding two paragraphs take corrective actions within a certain time limit. If corrective actions are not taken within the time limit, the application shall be denied.
Article 10
The certification body shall follow the implementation procedures and standards for type certification for processing applications for product certification.
The implementation procedures for type certification mentioned in the preceding paragraph shall include conformity assessment procedures at the design and production stages of the product, and shall be carried out based on types of products and production technologies.
Article 11
The certification body shall issue certificates of type certification with serial numbers when the application is reviewed to be in compliance.
The term of validity of the certificate of type certification shall be in a period of 3 years.
Article 12
The obligatory applicant may apply to the certification body for extension of the validity period by submitting an application for extension and related documents 3 months prior to the expiry date of the validity period. A new application for type certification shall be made if the application for extension is made after the expiry date.
Where the application for extension is approved by the certification body, the old certificate shall be collected before the new certificate is issued.
Article 13
The certification body may request that the production premise provide samples for testing, where necessary, for performing document review of type certification mentioned in the preceding Article. It may conduct testing of certain items, sampling, witnessed testing or visit the production premise to check the quality management and production processes.
The certification body shall obtain approval from the central competent authority before conducting witnessed testing mentioned in the preceding paragraph.
Article 14
The obligatory applicant shall maintain declaration of conformity and technical files for products type certified for period of not less than 10 years after the products are no longer produced.
Article 15
The same obligatory applicant shall not re-apply for type certification for the same type of products, unless there are situations specified in paragraph 1, Article 12.
Article 16
The type number of a product shall be used as the type for making the application for type certification. If the product has no type number, the specifications, characters or codes may be used as the type for type certification.
The type number, specifications, characters or codes of the product shall be easily identifiable and determined by the obligatory applicant when the application for type certification is made.
Products with the same basic design may be classified as series of types.
Article 17
For type-certified products, the obligatory applicant shall maintain that they comply with the name, type, specifications and functions stated in the certificate of type certification, and the actual products shall not be different from those stated in the certificate of type certification.
A new application for type certification shall be made if the name, type, specifications or functions stated in the certificate of type certification are to be changed.
Article 18
For type-certified products, when the central competent authority revises standards for type certification, the holder of the certificate of type certification shall apply for re-issuance of the certificate against the revised standards within the specified time limit.
Article 19
Where the importer of type-certified products is not the holder of the certificate of type certification, the importer may under the authorization of the certificate holder apply to the certification body for a prior-release notice for purpose of clearing the customs.
The scope of authorization mentioned in the preceding paragraph shall be applicable to all types of products stated in the certificate.
The certification body, upon receiving a notification from the certificate holder to terminate the authorization mentioned in paragraph 1, shall rescind the prior-release notice mentioned in paragraph 1 that it issued. The same shall be applicable to withdrawal or rescission of the compliance status of type certification as well as cancellation of the certificate of type certification.
Article 20
The obligatory applicant shall observe the following requirements for changes made to the design of type-certified products:
1.To make a new application for type certification when the basic design is changed,
2.To apply for series of type certification when the basic design is not changed yet changes are made to series of products,
3.To report to the certification body for record when the changes mentioned in the preceding subparagraph do not affect the information stated in the certificate and identification of the product.
The certification body may request the obligatory applicant to provide related documents, technical files or test reports, where necessary.
Article 21
For type-certified products, the obligatory applicant shall report to the certification body for revisions to the information stated in the certificate of type certification concerning the additions, changes or relocation of production premises and make an application for a replacement certificate.
Article 22
Where the certificate of type certification is lost or damaged, an application for replacement or re-issuance of certificate shall be made.
Where the content of certificate needs to be changed due to the application for adding series of types of the products, the obligatory applicant shall make a new application for re-issuance of certificate with the added information.