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法規名稱(Title) Regulations Governing Registration of Product Certification Ch
公發布日(Date) 2018.01.04
法規沿革(Legislative) Adopted and promulgated by Ministerial Order on 28 July 1999.
Amended and promulgated by Ministerial Order on 5 December 2001.
13 Articles amended and promulgated by Ministerial Order on 11 January 2005.
14 Articles amended and promulgated by Ministerial Order on 7 November 2006.
14 Articles amended and promulgated by Ministerial Order on 3 February 2010.
14 Articles amended and promulgated by Ministerial Order on 4 January 2018.
法規內文(Content)  
Article     1

These Regulations are established in accordance with Article 37 of the Commodity Inspection Act (the Act).

 

Article     2

An applicant for registration of product certification shall be either the manufacturer of the commodities or a person who entrusts others to manufacture the commodities (the manufacturer).  Where the manufacturer is located outside the territory of the Republic of China, the applicant shall be the sales agent or importer of the manufacturer who has its domicile or business place in the Republic of China.

 

Article     3

The conformity assessment procedures for registration of product certification shall be any of the following modules or their combinations:

1.   Internal Control Module - Module I: The applicant shall submit technical documents and declare that the manufactured commodities comply with the specified standards or relevant technical regulations.

2.   Type Test Module - Module II: The applicant or the production premises shall submit technical documents together with the type samples and obtain a type-test report indicating that the types are in compliance with specified standards or relevant technical regulations from the following organizations:

The Bureau of Standards, Metrology and Inspection (the BSMI) or its branches with jurisdiction over the particular applicant (all being referred to as the inspection authority hereinafter), or

Designated testing laboratories recognized by the BSMI.

3.   Declaration of Conformity to Type Module - Module III: The applicant shall draft a declaration of conformity-to-type and ensure that the manufactured commodities are in conformity with those in the type-test report.

4    Full Quality Management System Module - Module IV: The production premise is required to establish a quality management system that encompasses design, development, production, installation and servicing, and to obtain a registration certificate from the BSMI or certification bodies recognized by the BSMI, in accordance with the CNS 12681 (ISO 9001). A declaration of conformity-to-type is also required to ensure the manufactured commodities are in conformity with those in the type-test report.

5.   Production Quality Management Module - Module V: The production premise is required to establish a quality management system that encompasses production, installation and servicing, and to obtain a registration certificate from the BSMI, or certification bodies recognized by the BSMI, in accordance with the CNS 12681 (ISO 9001). A declaration of conformity-to-type is also required to ensure the manufactured commodities are in conformity with those in the type-test report.

6.   Product Quality Management Module - Module VI: The production premise is required to establish a quality management system that encompasses the final inspection and testing of the products, and to obtain a registration certificate from the BSMI, or certification bodies recognized by the BSMI, in accordance with the CNS 12681 (ISO 9001). A declaration of conformity-to-type is also required to ensure the manufactured commodities are in conformity with those in the type-test report.

7.   Factory Inspection Module - Module VII: The production premise is required to establish a quality management system that complies with the requirements stipulated by the BSMI, and to obtain a factory inspection report issued by the BSMI, or organizations recognized by the BSMI. A declaration of conformity-to-type is also required to ensure that the manufactured commodities are in conformity with those in the type-test report.

 

Article     4

An applicant shall submit the application form and the following documents to the BSMI or commissioned product certification bodies (hereinafter referred to as the certification bodies) when applying for registration of product certification:

1. A copy of the registration document of the company, business, ID card,factory or other equivalent establishment registration documents of the applicant except if identical documents have been previously registered with the certification bodies;

2. The declaration of conformity-to-type, the type-test report, relevant technical documents, a copy of quality management system registration certificate and/or a copy of factory inspection report as required by the appropriate modules; and

3. Other information or technical documents required by the BSMI.

If an applicant has been granted the use of other certification marks designated by the BSMI, the certificates of such marks may be presented in place of the related documents mentioned in the preceding items.

Under any of the following circumstances, the original type-test report shall not be submitted as conformity assessment documents

1. Where registration of product certification is revoked.

2. Where registration of product certification is rescinded in accordance with Paragraph One or Four of Article 42 of the Act.

3. Where registration of product certification is rescinded in accordance with Paragraph Nine of Article 42 of the Act, except when such products are designated and made known to the public by the BSMI per public notice.

A certificate issued under the Mutual or Multilateral Recognition Arrangements may be submitted in place of related documents mentioned in the first paragraph.

An applicant shall provide a signed declaration stating that the copies of the documents mentioned above are identical to the originals or current situation. If necessary, the certification bodies may require the applicant to present the original documents for verification.

If the documents and information submitted by the applicant are incomplete or insufficient, a notice shall be sent to the applicant to rectify and rectification shall be taken within two months after receiving the notice. If the applicant fails to rectify by the expiration of the preceding period or the rectification still does not meet the requirements, the application shall be rejected.

 

Article       4-1

An applicant shall not re-apply for registration of product certification for the same type of commodity except when an applicant makes a new application for registration of product certification for the same registered type within a period of three months prior to expiry of the certificate.

The registered type of commodity shall be designated in accordance with the commodity model. Specifications, other characters or codes shall be designated as the registered type when the commodity has no model.

The model, specifications, characters shall be unique in identification, and be designated by the applicant when the application is made.

 

Article     5

A registration certificate shall be issued to the applicant after the application has been reviewed and approved. Upon issuance of the certificate, the applicant will be permitted to use the certification mark in accordance with the Regulations Governing the Use of Commodity Inspection Marks.  Where the commodity inspection mark for certain products designated by the BSMI per public notice is to be printed by the BSMI, the certificate holder shall make an application to the certification bodies for obtaining such inspection mark labels by submitting information on the types, specifications and quantities of the registered products as well as other documents requested by the BSMI.

The certification bodies may request samples to be provided by the applicant for performing necessary testing or witness testing on specific features of the commodity.  The certification bodies may dispatch inspectors to the production premises to conduct on-site visits.

Where the registered products are sold to another person and marketed under the name of that person, the certificate holder shall report the name, address, or trade mark of that person to the certification bodies.

 

Article     6

A certificate holder may apply for extension of the term of validity by providing relevant documents within a period of three months prior to the expiration of the certificate. An extension is limited to one time only. For applications that are made after the expiration of the certificate, a new application for registration of product certification shall be required.

A new certificate will be issued after the application for extension of the term of validity mentioned in the preceding paragraph is reviewed and approved.

The extended term of validity of a registration certificate shall be determined according to that announced in Paragraph Two of Article 39 of the Act, beginning from the day following the expiry date of the original certificate.

Articles 4 to 5 shall apply to the application and review mentioned in the first paragraph of this Article.

 

Article     7

Commodities that have been granted registration may be shipped out of the production premise, or be exported or imported.  However, for commodities designated by the BMSI to be subject to border checks or checks before releasing from the production premises, the BSMI may issue a check notice to the certificate holder or importer. The commodities found to be compliant after the check shall be issued a conformity notice, which allows the commodities to be shipped out of the production premise, or be exported or imported. The commodities found to be non-compliant shall be disposed in accordance with Article 7-1.

If the exporter or importer of the registered product is not the certificate holder, they may obtain authorization from the certificate holder and import release notice from the certification bodies in order to pass through customs.

The scope of the authorization will cover all types of the commodities specified in the registration certificate.

Where the certificate holder informs the certification bodies that the authorization mentioned in the second paragraph is terminated, the certification bodies may rescind the import release notice previously issued. This shall also apply if the registration of product certification had been revoked or rescinded, or the registration certificate had been cancelled.

 

Article       7-1

If commodities that have been granted registration of product certification and found to be non-compliant as mentioned in the Proviso of the first paragraph of the preceding Article cannot be corrected, or cannot be corrected within a given time limit, the obligatory inspection applicant shall return the shipment, destroy or disassemble the commodities, or adopt other necessary measures within six months after receiving the notice of non-compliance.

When disposing of commodities mentioned in the preceding paragraph, the obligatory inspection applicant shall apply to the inspection authority for opening the seal, or may open the seal themselves after obtaining an approval from, and under the supervision of, the inspection authority. For commodities that are to be returned, an applicant shall report to the inspection authority and provide documents related to export, in order to close the case within three months after the commodities are returned. A case can also be closed on-line via crosschecking of the export information in the customs database by the inspection authority.

 

Article     8

For commodities that have been granted registration of product certification, the certification bodies may dispatch inspectors to the certificate holder, production premises, harbor warehouse, premise of the importer, distributor or relevant places to conduct sampling inspection, or to the production premises for surveillance visits.

The certificate holder or the production premises shall establish records of dates for manufacturing/sale of products, product types, specifications, quantities, dates of shipping products out of production premises, clients, customer complaints, processing and customer service and must retain the related technical documents. The records are subject to checks by the certification bodies.

For commodities that have been granted registration of product certification, the certification bodies may dispatch inspectors to the production premises to conduct checks at the manufacturing stage.

 

Article     9

If any changes are made to commodities that have been granted registration of product certification, the following procedures shall apply:

1. Where the basic design has been changed, a new application for registration shall be submitted;

2. Where the basic design remains the same but the inspection items of a serial commodity have been changed, an application shall be submitted for registration of this serial commodity; or

3. Where the basic design remains the same and the changes mentioned in the previous paragraph do not affect the registered items of certificate and commodity identification, an application for such changes shall be submitted to the certification bodies for permission. If necessary, the certification bodies may require that the applicant present the related supporting documents, technical documents and type-test reports for check.

Articles 4 and 5 shall apply to the application and review mentioned in the first and third subparagraphs of the preceding paragraph.

 

Article     10

For commodities that have been granted registration of product certification, an application for the increase, change or relocation of the production premises shall be made to the certification bodies for approval. Where the production premises are listed on the registration certificate, an application for replacing the certificate shall be required.

 

Article     11

The registration certificates shall be cancelled under any of the following circumstances:

1. Where the nominal holder of the certificate applies for cancellation of the certificate;

2. Where registration of the commodity is revoked or rescinded by the certification body.

3. Where the company, business, factory or other related registration of the certificate holder is revoked, rescinded, cancelled, dissolved, terminated or withdrawn.

If the registration certificate had been cancelled, the related authorized import release notice shall become ineffective at the same time.

Article     11-1

 Any type of registered product is inspected to be not in conformity with the inspection standards, the other types of registered products of the same structure under the same certificate shall be deemed to be not in conformity with the inspection standards as well. Together they shall be rescinded the registration of product certification in accordance with Paragraph One of Article 42 of the Act.

Article     12

An application for a replacement of the original registration certificate may be made if the original certificate is lost or damaged. The applicant may apply for a duplicate copy if needed.

When an application for registration of serial commodities is made and if the registered items on the certificate would be affected, the original certificate shall be returned before issuance of a replacement certificate with the addition of the registered serial commodities.

 

Article   13

The certification bodies shall issue conformity assessment certificates to the applicants in accordance with the Mutual or Multilateral Recognition Arrangements.

 

Article     14

These Regulations shall take effect from the date of promulgation.