機械類產品型式驗證實施及監督管理辦法

These Regulations are established in accordance with Paragraph 5, Article 8 of the Occupational Safety and Health Act (the Act).

1The terms and vocabulary used in these Regulations shall be defined as follows:

21. Mechanical products: machinery, equipment or appliances, imported or domestically manufactured, announced to be subject to type certification by the central competent authority in accordance with Paragraph 1, Article 8 of the Act.

32. Produce: manufacture, make, process or modify, including the assembly of individual components to final mechanical products for sale, and modification of the products for purpose of sale before they are placed on the market.

43. Certification procedures: conformity assessment procedures as mentioned in the Agreement on Technical Barriers to Trade, including any of the following procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.

5(1) procedures for sampling, testing and inspection;

6(2) procedures for evaluation, verification and assurance of conformity;

7(3) procedures for registration and approval;

8(4) combinations of the procedures mentioned in the preceding 3 subparagraphs.

94.Certification body: bodies that are approved to perform type certification in accordance with Paragraph 1, Article 8 of the Act.

1The obligatory applicant for mechanical products (hereinafter referred to as the products) shall be:

21.the manufacturer, if the products are produced domestically. Where the products are contracted to others to produce and are placed on the market under the name of the contractor who has domiciles or business offices in Taiwan, the contractor shall be the obligatory applicant.

32.the importer, if the products are produced in foreign countries. Where the products are contracted to others to import and are placed on the market under the name of the contractor who has domiciles or business offices in Taiwan, the contractor shall be the obligatory applicant.

43.the seller of the products, if the manufacturer/importer/contractor of production or contractor of import is unknown and not able to be traced.

Products that are subject to type certification in accordance with Paragraph 1, Article 8 of the Act shall not be shipped out of the production premises or imported if they are not type certified by the certification bodies, do not obtain the certificate of conformity to type certification (Appendix) and do not put up the certification labels, except that an application for prior release is approved in accordance with Paragraph 4, Article 8 of the Act.

The implementation procedures, items and standards for certification shall be stipulated and published by the central competent authority by following requirements of international trade or labor treaties and consulting relevant national standards, international standards or other technical regulations.

1The obligatory applicant shall apply to certification bodies for type certification by completing an application form and providing the following documents:

21.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.

32.Basic information about the products:

4(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.,

5(2)reasons for products being classified as the same type,

6(3)list of the main type and series of the type,

7(4)drawings of the construction, including illustration of the location of the product safety devices and their functions,

8(5)drawings of the electric, hydraulic or pneumatic circuit, if applicable,

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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.

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.

1The technical files provided by the obligatory applicant shall be written in Chinese and may be supplemented with information in English or other languages.

2Where 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.

3The 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.

1The certification body shall follow the implementation procedures and standards for type certification for processing applications for product certification.

2The 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.

1The certification body shall issue certificates of type certification with serial numbers when the application is reviewed to be in compliance.

2The term of validity of the certificate of type certification shall be in a period of 3 years.

1The 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.

2Where the application for extension is approved by the certification body, the old certificate shall be collected before the new certificate is issued.

1The 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.

2The certification body shall obtain approval from the central competent authority before conducting witnessed testing mentioned in the preceding paragraph.

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.

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.

1The 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.

2The 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.

3Products with the same basic design may be classified as series of types.

1For 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.

2A 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.

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.

1Where 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.

2The scope of authorization mentioned in the preceding paragraph shall be applicable to all types of products stated in the certificate.

3The 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.

1The obligatory applicant shall observe the following requirements for changes made to the design of type-certified products:

21.To make a new application for type certification when the basic design is changed,

32.To apply for series of type certification when the basic design is not changed yet changes are made to series of products,

43.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.

5The certification body may request the obligatory applicant to provide related documents, technical files or test reports, where necessary.

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.

1Where the certificate of type certification is lost or damaged, an application for replacement or re-issuance of certificate shall be made.

2Where 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.

1Government agencies, academic institutes or non-profit legal persons possessing the following qualifications may apply to the central competent authority for becoming recognized certification bodies:

21.To have the competence to perform certification activities and be impartial, have a fixed place for business, have a sound organization structure and have good financial infrastructure,

32.To have established product certification systems in compliance with ISO/IEC 17065 or other equivalent standards, and to be accredited by the accreditation body in Taiwan recognized by the central competent authority in relevant fields,

43.To have professional testing laboratories related to type certification and be accredited against ISO/IEC 17025 in relevant fields,

54.To have one full-time professional certification personnel for each product category it intends to provide certification service, and

65.Other qualifications stipulated by the central competent authority.

1The certification personnel shall possess one of the following qualifications:

21.master degrees from mechanical or electrical engineering programs of graduate schools or higher of public or private universities in Taiwan or in other countries recognized by the Ministry of Education, and participation in certification-related research, design, production, safety inspection, safety testing, or having on-hand type verification experience, for 2 years or more with demonstration documents,

32.graduated from mechanical or electrical engineering departments of public or private universities or colleges in Taiwan or in other countries recognized by the Ministry of Education, and participation in certification-related research, design, production, safety inspection, safety testing, or having on-hand type verification experience, for 5 years or more with demonstration documents,

43.graduated from mechanical or electrical engineering departments of vocational high schools in Taiwan or in other countries recognized by the Ministry of Education, and participation in certification-related research, design, production, safety inspection, safety testing, or having on-hand type verification experience, for 7 years or more with demonstration documents, or

54.other qualifications recognized by the central competent authority.

The certification personnel shall be familiar with technical regulations and technical specifications related to type certification and shall be registered after having taken training courses given by the central competent authority or professional groups recognized by the central competent authority before they can conduct type certification activities.

The registered certification personnel mentioned in the preceding Article shall not conduct inspection involved in the process of type certification.

1The organization meeting the qualification requirements specified in Article 23 (hereinafter referred to as the applicant) shall complete an application form and submit the following documents when they apply for becoming a recognized certification body:

21.Documents stating the scope of product certification,

32.Copies of demonstration documents of qualifications in compliance with Article 23 and related supporting documents,

43.List of certification personnel and the product certification activities they are in charge of,

54.Explanations about the organizational chart and functions,

65.Layout of the offices and working areas as well as a simple graphic of geographical locations,

76.Quality manuals, structure and list of quality documents, and

87.Other documents that are deemed necessary by the central competent authority.

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1The central competent authority may establish an assessment team comprised of academic scholars and experts to conduct on-site assessment if the application documents provided by the applicant comply with the requirements mentioned in the preceding Article.

2The on-site assessment mentioned in the preceding paragraph shall cover the following items and an assessment report shall be provided:

31.Compliance of the product certification systems with ISO/IEC 17065 or other equivalent standards,

42.Ability to implement technical regulations, operation procedures, safety standards, national standards or international standards, required by type certification activities for the products,

53.Ability to manage risks specified in national standards, international standards or other relevant standards, in order to implement type certification activities for the products,

64.Availability of internal documents required for the employment, training, recognition, surveillance, assessment and management of certification personnel and the ability to implement the documents,

75.Availability of internal documents for the recognition of qualifications, surveillance, assessment, maintenance and management of internal and external conformity assessment bodies, in order to promote type certification activities for the products, and the ability to implement the documents,

1The central competent authority shall issue an approval document and publish the recognition status of the applicant to perform type certification activities of products, if the on-site assessment mentioned in the preceding Article yields approval of the application.

2The certification body shall conduct type certification activities in its name. Nevertheless, conformity assessment activities related to type certification may be subcontracted to conformity assessment bodies approved by the central competent authority based on its professional and technological needs.

3Where the certification body intends to have the conformity assessment activities mentioned in the preceding paragraph be done in the manner of witnessed testing or on-site testing, it shall prepare related evaluation and analysis reports and obtain approval from the central competent authority.

1The term of validity of the recognition granted to certification bodies shall be in a period of 3 years. Applications for extension of the validity period may be made by the certification body 60 days prior to the expiry date.

2Where the central competent authority approves the application for extension mentioned in the preceding paragraph, the requirements stipulated in Paragraph 1, Article 29 regarding the publication of recognition status shall apply mutandis mutatis.

The certification body performing type certification and related conformity assessment activities shall not deny or discriminate applications without justified reasons.

The certification body shall transmit electronic files of related documents concerning type certification, implementation status and results to Information Reporting Website designated by the central competent authority for record.

1The certification body shall apply to the central competent authority for approval if it intends to extend certification scope or items by submitting an application form and related documents. A new approval of recognition shall be issued.

2Where the accreditation scope of the certification body is reduced by the accreditation body in Taiwan, the certification body shall stop performing conformity assessment activities in relevant type certification fields affected by the reduction of accreditation scope. An application for changes to the type certification scope shall be made to the central competent authority for issuing a new approval of recognition.

The certification body shall apply to the central competent authority by submitting related documents for changes to the content of approval documents within 3 months after it relocates to a new address or modifies its basic information. Type certification activities shall not be conducted before approval of the changes is granted.

The certification body shall report to the central competent authority for record within 15 days when there are changes to the certification personnel as a result of resignation, recruitment or employment.

1The central competent authority may order the certification body to stop conducting type certification activities when there are vacancies of certification personnel leading to non-conformities to subparagraph 5 of Article 23.

2The certification body shall apply to the central competent authority for resuming the conduction of type certification by submitting the basic information of the certification personnel after the vacancies mentioned in the preceding paragraph are filled.

The certification body shall not accept applications for type certification 30 days prior to the expiry date if it does not obtain approval from the central competent authority for extending the term of validity.

The central competent authority shall perform regular checks and irregular monitoring to certification bodies each year and the certification body shall not evade, impede or refuse the checks or monitoring without justified reasons.

1Under any of the following circumstances, the central competent authority may order the certification body to stop performing type certification activities and request that correction actions be taken within a certain time limit:

21.where its accreditation status is suspended by the accreditation body in Taiwan,

32.where the approval is granted by the central competent authority for conformity assessment bodies it subcontracted,

43.where the documents are not provided without justified reasons within the specified time limit,

54.where it refuses to be checked by the central competent authority without justified reasons, or

65.where it does not assist in processing appeals, complaints or disputes that it has the obligation to provide assistance.

7Conduction of type certification shall be resumed only after the situations mentioned in the preceding paragraph are improved and confirmed by the central competent authority to be in compliance with related requirements.

1Under any of the following circumstances, the central competent authority shall withdraw or rescind the approval granted to the certification body:

21.where the certification body applies for terminating the approval,

32.where the accreditation of the certification body is withdrawn or rescinded by the accreditation body in Taiwan,

43.where the approval of subcontracted conformity assessment bodies was withdrawn or rescinded by the central competent authority,

54.where the certification body loses the ability to perform type certification activities or is unable to maintain impartiality to perform type certification activities effectively,

65.where the principles of avoidance of conflict of interest or observance of confidentiality are violated,

76.where the certification body performs type certification or conformity assessment activities beyond the scope it is authorized or in a manner of tardiness,

87.where the provisions of Article 31 are violated,

1For circumstances mentioned in Article 37 and the preceding Article, the certification body shall forward cases not completed to other certification bodies designated by the central competent authority.

2The certification body of which the approval of recognition is withdrawn or rescinded shall not apply for becoming a recognized certification body within 3 years from the date the approval is terminated, except where recognition is terminated as a result of application made by the certification body in accordance with subparagraph 1 of the preceding Article.

The certification body shall deliver the complete files of all conformity assessment cases related to type certification to organizations designated by the central competent authority within 7 days before the expiry date of recognition.

The central competent authority may, in accordance with Article 52 of these Regulations, subcontract domestic professional groups to conduct assessments of competence, confirmation of technological consistency, training of human resources and review of qualifications, management of registration, etc. of the certification bodies.

1Under any of the following circumstances, the central competent authority shall cancel the certificate of type certification issued to the obligatory applicant:

21.where cancellation of the certificate is made upon application by the obligatory applicant,

32.where the registration document of establishment is withdrawn , rescinded or cancelled in accordance with related laws,

43.where the business entity is dismissed or shut down or its approval is withdrawn, or

54.where non-conformities are found by the central competent authority during checks.

1Where the certificate of type certification is obtained by fraudulent or deceptive means, the central competent authority shall withdraw related qualifications of the obligatory applicant and shall request the certificate be returned within a certain time limit. Where criminal charges are involved, the cases shall be forwarded to judicial organizations for processing.

2For the situation mentioned in the preceding paragraph occurs to mechanical products with special structures, where the central competent authority withdraws the approval for using appropriate inspection methods, the type certification label shall be withdrawn accordingly and the certification body shall request that the certificate of type certification be returned within a certain time limit.

1Under any of the following circumstances involving the obligatory applicant, the central competent authority shall rescind the certificate of type certification:

21.where the inspection results of purchased products or sampled products do not comply with the standards of type certification,

32.where the certificate of type certification, technical files or samples are not provided within the notified time limit or are not intended to be provided without justified reasons,

43.where the certified product causes significant hurt or damages due to defects,

54.where the products do not comply with labeling requirements and corrective actions are not taken within the notified time limit,

65.where the declaration of conformity and technical files of type-certified products are not maintained for the specified time period in accordance with the provisions of Article 14,

76.where the provisions of Article 17 are violated because the products are different from those stated in the certificate of type certification and corrective actions are not completed within the notified time limit,

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1Where bilateral or multilateral mutual recognition agreements or conventions are signed between the Republic of China with other countries, regional organizations or international organizations, the central competent authority may recognize test reports, inspection certificates or other related certification documents in accordance with the obligations specified in such agreements or conventions.

2For imported products, the certification body may recognize the foreign test reports, inspection certificates and other related certification documents provided by the obligatory applicant and recognized by the central competent authority in accordance with the provisions of the preceding paragraph. The whole or part of the certification or testing stipulated in Article 4 can therefore be waived. The certification body may apply to the central competent authority for approval on the acceptance of test reports via the arrangement of mutual recognition between testing laboratories if such agreements or conventions do not exist, or there are difficulties in accepting such certificates due to special reasons.

The forms of documents mentioned in these Regulations shall be prescribed by the central competent authority.

These Regulations shall take effect on January 1, 2015.