These Regulations are established in accordance with Article 37 of the Commodity Inspection Act
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.
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 as well as
ensure and declare that its production premises are registered under their consent, and are the actual
factories manufacturing the registered commodities which 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
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 declare and ensure
that its production premises are registered under their consent, and are the actual factories
manufacturing the registered commodities which comply with those types in Module II.
4.Full Quality Management System Module - Module IV: The production premises shall obtain a
registration certificate regarding the quality management system that encompasses design,
development, production, and manufacturing from the certification bodies recognized by the BSMI,
in accordance with the CNS 12681 (ISO 9001).
5.Production Quality Management Module - Module V: The production premises shall obtain a
registration certificate regarding the quality management system that encompasses production and
manufacturing from the certification bodies recognized by the BSMI, in accordance with the CNS
12681 (ISO 9001).
6.Product Quality Management Module - Module VI: The production premises shall obtain a
registration certificate regarding the quality management system that encompasses the final
inspection and testing of the products from the certification bodies recognized by the BSMI, in
accordance with the CNS 12681 (ISO 9001).
7.Factory Inspection Module - Module VII: The production premises shall obtain a factory
inspection report issued by the BSMI or certification bodies recognized by the BSMI.
The applicant of the Subparagraph 4-7 of the preceding Paragraph shall also comply with the
requirements of Declaration of Conformity to Type Module of the Subparagraph 3 of the preceding
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.The photocopies of the registration documents of the company, business, factory, ID or other
equivalent establishment registration documents of the applicant except if identical documents have
been previously registered with the certification bodies or those Unified Business Numbers filled
are available to be searched at the official site of the competent authority;
2.The photocopies of declaration of conformity-to-type, the type-test report, relevant technical
documents, quality management system registration certificate or a copy of factory inspection
3.Other related materials and technical documents required by the BSMI.
If the 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
A certificate issued under the Mutual or Multilateral Recognition Arrangements may be submitted in
place of related documents mentioned in the Paragraph 1.
For photocopies of documents required by the Paragraph 1, the applicant shall provide a signed
declaration stating that the copies are identical to the originals or current situation. The certification
bodies may, as necessary, request the submission of originals for verification.
If there is any insufficiency or inconformity among the documents submitted by the applicant based
on the Regulations, the applicant shall make necessary corrections within two months upon
receiving of the notice. The application will be rejected if the applicant fails to do so.
For registration of any product certification, the applicant may make applications to certificate
bodies at different jurisdictions.
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
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.
The original type-test report shall not serve as the conformity assessment document of Paragraph 1
of Article 4 if there is any existence of the following occasions:
1.The registration of product certification has been revoked or rescinded;
2.The test results of commodities purchased or sampled are not in compliance with the inspection
standards, starting the next date after the date of the test results approved;
3.Any severe injury to any person or endangered public safety caused by the defects of the
registered commodities, starting the next date after the date of occurrence of such event;
4.Failure to replace the registration certificate within a given time limit according to the revised
inspection standards in accordance with Paragraph 2 Article 40 of the Commodity Inspection Act,
excluding those specifically designated and publicly announced by the BSMI.
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.
For the review mentioned in the preceding Paragraph, the certification bodies may request samples
to be provided by the applicant for performing necessary testing or witness testing on specific
features of the commodities. The certification bodies may dispatch inspectors to the production
premises to conduct on-site visits.
Where the registered commodities are sold to other person and marketed under the name of such
person, the certificate holder shall report the name, address, or trade mark of that person to the
The registration certificate mentioned in Paragraph 1 may be issued in the electronic format.
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
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
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.
If commodities that have been granted registration of product certification are found to be
non-compliant as mentioned in the Proviso of the Paragraph 1 of the preceding Article and such
non-compliance cannot be corrected, or cannot be corrected within a given time limit, the obligatory
applicant shall make return, destroy or disassemble such commodities to a level of unserviceability,
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 applicant
shall apply to the inspection authority for removing the seal, or may remove the seal themselves
after obtaining an approval from, and under the supervision of, the inspection authority. For
commodities that are to be returned, the applicant shall report to the inspection authority and
provide the re-export declaration and related documents 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 database of the Customs Administration, Ministry of Finance by the inspection
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.
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.
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.
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.
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 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 duplicate copies if necessary.
The new certificate may be directly issued if an application for registration of serial commodities is
made and such commodities have been reviewed and approved.
The certification bodies shall issue conformity assessment certificates to the applicants in
accordance with the Mutual or Multilateral Recognition Arrangements.
These Regulations shall take effect from the date of promulgation.