Attachment 

No.CNCA-00C-008:2019

Compulsory Certification Implementation Rules

Self-Declaration of Conformity

Published: 2019-12-25 Implemented: 2020-01-01

National Certification and Accreditation Administration of the People’s Republic of China

Contents

0. Introduction 1

1. Scope 1

2. Definition 1

2.1 Manufacturer 1

2.2 Authorized Representative 2

2.3 Production Enterprise 2

2.4 Importer 2

2.5 Distributor 2

2.6 Commercial Users 3

2.7 Self-Declaration Procedure 3

2.8 Self-Declaration of Conformity 3

2.9 Self-Selected Laboratory 3

2.10 Designated Signatory 3

3. Self-Declaration Procedure 4

3.1 Self-Declaration Procedure 4

3.2 Classification of Self-Declaration Procedures 5

4. Conformity Information Submission Requirements 7

4.1 System Registration 7

4.2 Submission of Conformity Information 7

4.3 Signing and Submission of Self-Declaration of Conformity 9

5. Changes to the Self-Declaration 10

6. Cancellation of the Self-Declaration 10

7. Validity Period of the Self-Declaration 11

8. Requirements for the Use of the CCC Mark 11

9. Post-Market Surveillance 12

10. Responsibilities and Obligations of Relevant Parties 14

Annex 1. Technical Documentation 16

Annex 2. Template for the Self-Declaration of Conformity for China Compulsory Certification Products 18

0. Introduction

With a view to deepening reform and innovation of the quality certification system, strengthening the principal responsibility of enterprises, reducing institutional transaction costs, and optimizing the China Compulsory Certification (CCC) procedure, by benchmarking advanced international conformity assessment systems, the CCC system has added the self-declaration of conformity evaluation method on the basis of third-party certification. For products subject to the self-declaration of conformity within the CCC catalogue, the manufacturer shall complete self-evaluation and submit product conformity information in accordance with these Rules, and affix the CCC mark to the product.

1. Scope

These Rules apply to products within the CCC catalogue that are subject to self-declaration of conformity evaluation method.

These Rules specify the definitions, self-declaration procedures, conformity information submission and self-declaration requirements, CCC mark, post-market surveillance, and responsibilities and obligations of relevant parties under the self-declaration of conformity evaluation method.

2. Definition

2.1 Manufacturer

An enterprise that designs and produces products, or entrusts others to design and produce products, and sells them under its own name/trademark, which shall bear the main responsibility for product quality and possess independent legal personality.

2.2 Authorized Representative

A legally registered enterprise within the territory of China that, upon the written authorization of an overseas manufacturer, submits product conformity information to the “Compulsory Certification Product Conformity Self-Declaration Information Submission System” (http://sdoc.cnca.cn) and submit the self-declarations on behalf of the overseas manufacturer, and together with the overseas manufacturer bears responsibility with the overseas manufacturer for the safety and quality of the products of the self-declared products and cooperates with the market regulatory authorities in post-market surveillance.

An overseas manufacturer may choose its subsidiaries, importers, or distributors as the authorized representatives.

2.3 Production Enterprise

An enterprise that actually carries out the production or assembly of products as entrusted by the manufacturer.

2.4 Importer

A legally registered enterprise within the territory of China that imports products from outside China for sale in the Chinese market.

2.5 Distributor

A legally registered enterprise within the territory of China that sells products.

2.6 Commercial Users

A company or individual within the territory of China that uses products for commercial purposes.

2.7 Self-Declaration Procedure

A conformity assessment procedure used to determine whether a product meets the requirements of these Rules and the applicable standards for CCC certification.

2.8 Self-Declaration of Conformity

A declaration issued by the manufacturer to confirm that the product complies with the requirements of these Rules and the applicable standards for CCC, based on the conformity assessment results.

2.9 Self-Selected Laboratory

A laboratory freely chose by the manufacturer to conduct type test.

A self-selected laboratory may be an in-house laboratory of the manufacturer or production enterprise, or a third-party laboratory.

2.10 Designated Signatory

An internal personnel directly responsible for the self-declaration and authorized in writing by the manufacturer or authorized representative to sign the self-declaration on behalf of the manufacturer or authorized representative. This person may also be the legal representative.

3. Self-Declaration Procedure

3.1 Self-Declaration Procedure

3.1.1 The manufacturer shall, with the objective of ensuring the continuous compliance of its self-declared products with the applicable standards for CCC, implement in-house quality control and establish a factory quality assurance system in accordance with these Rules and the corresponding product-specific CCC implementation rules, taking into account product characteristics and production and processing features.

3.1.2 The manufacturer shall select an appropriate type of conformity assessment method (see Section 3.2) to evaluate product conformity and to demonstrate that the product continuously meets the applicable standards for CCC.

3.1.3 The manufacturer shall establish and properly retain technical documentation in accordance with Annex 1 to these Rules. Such documentation shall be retained at least 10 years for inspection, starting from the date of completion of the product conformity information submission.

3.1.4 The manufacturer and the authorized representative (where applicable) shall sign the “Self-Declaration of Conformity for China Compulsory Certification Products” (see Annex 2 for the template) for products that have passed the conformity assessment and complete the product conformity information submission.

3.1.5 The manufacturer shall affix the CCC mark to the products covered by its self-declaration.

3.1.6 When there are changes in product design, technical characteristics, relevant CCC requirements or information related to the self-declaration, the manufacturer or the authorized representative (where applicable) shall conduct a supplementary conformity assessment in light of the changes, and update the self-declaration and product conformity information accordingly.

3.2 Classification of Self-Declaration Procedures

The self-declaration procedures are divided, according to different types of conformity assessment, into self-declaration procedure A and self-declaration procedure B.

3.2.1 Self-Declaration Procedure A

The conformity assessment methods applicable to self-declaration Procedure A are as follows:

Type test shall be conducted by a self-selected laboratory, which issues the type test report. The manufacturer shall organize a self-inspection of its factory quality assurance capability and issue a self-inspection report. The self-selected laboratory shall meet the requirements specified in Section 3.2.3.

Alternatively, the manufacturer may freely choose a certification body to conduct voluntary certification of its products. The certification body shall meet the requirements specified in Section 3.2.4. The certification process shall include at least type test and factory inspection. The laboratory conducting the type test shall satisfy the requirements for a self-selected laboratory.

3.2.2 Self-Declaration Procedure B

The conformity assessment methods applicable to self-declaration Procedure B are as follows:

Type test shall be conducted by a laboratory designated for the business scope of CCC (hereinafter referred to as the designated laboratory)which issues the type test report. The manufacturer shall organize a self-inspection of its factory quality assurance capability and issue a self-inspection report.

Alternatively, the manufacturer may freely choose a certification body to conduct voluntary certification of its products. The certification body shall meet the requirements specified in Section 3.2.4. The certification process shall include at least type test and factory inspection. The laboratory conducting the type test shall be a designated laboratory.

3.2.3 Requirements for Self-Selected Laboratories

The operation of a self-selected laboratory shall comply with the laws and regulations of the country (region) where it is located and shall have the testing capability required for the applicable CCC standards.

A third-party laboratory registered within China shall obtain qualification accreditation for inspection and testing bodies.

A third-party laboratory registered outside China shall be accredited by CNAS (or an ILAC member body).

A laboratory owned by the manufacturer or production enterprise shall comply with GB/T 27025 (or the equivalent ISO/IEC 17025) standard, and accreditation by CNAS (or an ILAC member body) is encouraged.

3.2.4 Requirements for Certification Bodies

A certification body shall be established in accordance with the law, comply with the Administrative Measures for Certification Bodies, and possess certification qualification in the relevant field.

A certification body shall comply with GB/T 27065 (or the equivalent ISO/IEC 17065) standard, and accreditation by CNAS (or an ILAC member body) is encouraged.

4. Conformity Information Submission Requirements

4.1 System Registration

Manufacturers, laboratories involved in the self-declarations, and certification bodies (if applicable) shall register in the “Compulsory Certification Product Conformity Self-Declaration Information Submission System” (hereinafter referred to as the System) and submit relevant organizational information and supporting documents attesting to their qualifications.

4.2 Submission of Conformity Information

4.2.1 Under normal circumstances, the manufacturer or the authorized representative (where applicable) shall submit the following conformity information:

a) Self-Declaration product information;

b) Information on the applicable standards met by the product;

c) Type test report;

d) Factory quality assurance capability inspection report (self-inspection or entrusted to a third party);

e) Information on the voluntary product certification certificate (where applicable);

f) Information on the laboratories and certification bodies (where applicable) involved in the self-declaration, and their relevant qualification certificates;

g) Other information related to product conformity.

The product information submitted in the self-declaration, such as product name, model/specification, production enterprise and manufacturer, shall be consistent with the actual product and shall be covered by the type test and voluntary certification (where applicable).

4.2.2 Where the manufacturer commissions the design and production of products under the ODM mode, the following conformity information shall be submitted:

a) Self-Declaration product information;

b) Information on the applicable standards met by the product;

c) Initial self-declaration information;

d) ODM agreement between the manufacturer, the ODM initial self-declaration manufacturer and production enterprise;

e) Agreement concerning the self-declaration and product quality and safety responsibilities between the manufacturer, the ODM initial self-declaration manufacturer and production enterprise;

f) Nameplate (external identification) of the ODM product;

g) Other information related to product conformity.

4.2.3 The self-selected laboratory or the designated laboratory shall, at the request of the manufacturer or the authorized representative (where applicable), submit in the System the type test report and relevant information for the self-declaration products.

4.2.4 Where applicable, the relevant certification body shall, at the request of the manufacturer or the authorized representative (where applicable), submit to the System the certification certificate, type test report, factory inspection report and relevant information of the self-declaration products of that manufacturer or authorized representative.

4.3 Signing and Submission of Self-Declaration of Conformity

After the above conformity information has been submitted, the System will automatically generate a “Self-Declaration of Conformity for Compulsory Certification Products” based on the submitted information. The designated signatory of the manufacturer or the authorized representative (where applicable) shall sign it, upload it to the System, and complete the submission of the self-declaration. The information on the self-declaration can be queried on the CNCA website.

5. Changes to the Self-Declaration

When there are changes in product design, technical characteristics, relevant CCC requirements or other information in the self-declaration, the manufacturer or the authorized representative (where applicable) shall select an appropriate conformity assessment method to conduct supplementary evaluation of product conformity based on the changes and update the relevant information in the System. If the changes involve amendments to the content of the type test report, the amended report and relevant information for the self-declaration shall be submitted in accordance with Section 4.2.3 or Section 4.2.4 of these Rules.

For the self-declaration under the ODM mode in accordance with Section 4.2.2, changes affecting the product technical characteristics must be initiated by the manufacturer that made the initial ODM self-declaration, and other associated ODM self-declaration manufacturers shall complete the changes to their self-declarations within one month; otherwise, the relevant ODM self-declaration will be canceled by the system.

6. Cancellation of the Self-Declaration

The manufacturer or authorized representative (where applicable) may, as needed, voluntarily cancel the self-declaration. After cancellation, the System will retain the original submitted information for future reference as required.

After the initial ODM self-declaration is canceled, the system will automatically cancel other associated ODM self-declarations.

7. Validity Period of the Self-Declaration

The self-declaration is valid for 10 years and will be automatically canceled by the System upon expiration.

If the manufacturer needs to extend its validity, it shall apply for the extension within 90 days before the expiry of the validity period.

The validity period of the ODM-related self-declaration is the same as the validity period of its initial self-declaration.

8. Requirements for the Use of the CCC Mark

After completing the self assessment and product conformity information submission in accordance with these Rules and signing the self‑declaration, the manufacturer or the authorized representative (where applicable) shall affix the CCC mark (see the figure below) to the product.

The manufacturer and the authorized representative (where applicable) shall ensure that the management and use of the CCC mark comply with the provisions of the Provisions on Administration of China Compulsory Certification (CCC), the Announcement of Certification and Accreditation Administration of the People’s Republic of China on Matters Concerning the Reform of CCC Mark (CNCA Announcement No. 10, 2018), and other relevant requirements.

The CCC mark shall not be affixed under any of the following cases:

a) The conformity assessment has not been completed, the self-declaration of conformity has not been signed, and the conformity information has not been submitted in accordance with these Rules;

b) The product has been changed but the relevant conformity information has not been updated in the System;

c) Other circumstances that do not comply with the relevant requirements of CCC.

9. Post-Market Surveillance

9.1 CNCA is responsible for organizing and implementing the supervision and administration of self-declarations and the use of the CCC mark. Market regulatory authorities at all levels shall be responsible for supervising and administering the self-declarations and the use of the CCC mark within their respective jurisdictions.

9.2 The manufacturer and the authorized representative (where applicable) shall cooperate with post-market surveillance and as required by market regulatory authorities, be able to provide the CCC self-declaration and related documents. The manufacturer and the authorized representative (where applicable) shall ensure that distributors/commercial users can also provide or access the self-declaration information of the products they sell or use.

9.3 In any of the following circumstances,the manufacturer/importer/distributor/commercial user shall cease to manufacture/import/sell/use the products covered by the corresponding self-declaration; the System shall withdraw the relevant self-declaration and publish it; for products whose self-declarations have been withdrawn, the manufacturer and the authorized representative (where applicable) may not re-apply for a new self-declaration within 6 months; the relevant credit information will be included in the National Enterprise Credit Information Publicity System.

a) The Product covered by the self-declaration is found, through supervision and random inspections by market regulatory authorities at any levels to have serious defects or to fail the product safety test items;

b) The product covered by the self-declaration has a defect that leads to a quality or safety accident;

c) There is fraud or improper means used to complete the self-declaration and information submission, or any other act that directly affects the validity of the self-declaration;

d) Refusal to accept supervision sampling without justifiable reason;

e) Other circumstances where the self-declaration should be withdrawn.

9.4 In any of the following circumstances, the manufacturer shall take corrective actions and update relevant information. where necessary, the manufacturer/importer/distributor/commercial user shall cease to manufacture/import/sell/use the products covered by the corresponding self-declaration:

a) The manufactured or imported product is inconsistent with the product covered by the self-declaration;

b) The CCC mark has not been correctly affixed in accordance with these Rules;

c) The self-declaration has not been signed in accordance with these Rules;

d) The content of the self-declaration or the submitted conformity information does not comply with the requirements of these Rules;

e) The technical documentation cannot be provided or does not comply with the requirements of these Rules;

f) Other administrative requirements of these Rules have not been met.

9.5 For manufacturers/importers/sellers/commercial users that fall under the circumstances listed in Sections 9.3 and 9.4 on two or more occasions, CNCA will publish the list of such parties and the results of the actions taken.

9.6 When the initial ODM self-declaration or any of its associated self-declaration falls under the circumstances listed in Sections 9.3 and 9.4, if the issue relates to product safety and quality, the same measures shall be taken against all ODM-related self-declarations.

10. Responsibilities and Obligations of Relevant Parties

Manufacturers, authorized representatives (where applicable), distributors, importers, commercial users, and other parties involved in the implementation of a self-declaration under these Rules shall strictly comply with the requirements of the Product Quality Law of the People’s Republic of China and other applicable laws and regulations, and shall bear the corresponding responsibilities and obligations for product quality.
Annex 1 

Technical Documentation

The manufacturer shall establish technical documentation. The technical documentation shall be sufficient to demonstrate that the product meets the requirements of CCC and shall obtain a thorough risk analysis. The technical documentation shall specify relevant requirements and include information on the design, production, and use of the product.

Where applicable, the technical documentation shall contain at least the following contents:

1. Product description (a comprehensive description of the product characteristics, including model/specifications, technical parameters, structure, electrical schematic, etc.);

2. List of critical components/raw materials;

3. Structural diagram;

4. Circuit diagram;

5. Design and production drawings;

6. Product use/operation instructions;

7. List of applicable CCC standards for the product;

8. Type test report;

9. Factory quality assurance capability inspection report;

10. Information on the relevant laboratories or certification bodies, their qualifications and technical competence, and detailed information on their accreditation status (e.g., scope of accreditation, name of the accreditation body, etc.);

11. Product change information;

12. Other related information.

Annex 2 

Template for the Self-Declaration of Conformity for China Compulsory Certification Products

(Applicable to Domestic Manufacturers)

Self-Declaration No.:

(Manufacturer Name) (manufacturer) hereby acknowledges the requirements of the Compulsory Certification Implementation Rules — Self-Declaration of Conformity and the relevant product-specific CCC implementation rules, and assumes full legal responsibility for this self-declaration.

(Manufacturer Name) (manufacturer) hereby declares that the following products have been evaluated by appropriate conformity assessment methods in accordance with the requirements specified in the Compulsory Certification Implementation Rules — Self-Declaration of Conformity and the relevant product-specific CCC implementation rules, and that they comply with the requirements of the applicable standards. From the date of signing this declaration, the products manufactured and sold will continuously comply with the following standards and implementation rules. The manufacturer will keep the technical documentation relating to this self-declaration for at least 10 years, will use the CCC mark correctly, and will promptly update the technical documentation and submit the product change information if the product or its conformity information changes.

Manufacturer Name:

Manufacturer Address:

Product Name:

Product Series, Model(s), and Specification(s):

Production Enterprise Name:

Production Enterprise Address:

Applicable Compulsory Product Certification Rules:

Applicable Standards:

Note: The authenticity of the information in this declaration can be verified via the National Certification and Accreditation Information Public Service Platform (cx.cnca.cn) or by scanning the QR code in the upper right corner.

Template for the Self-Declaration of Conformity for China Compulsory Certification Products

(Applicable to Domestic Manufacturers)

Self-Declaration No.:

Annex

Product Series, Model(s), and Specification(s):

Note: The authenticity of the information in this declaration can be verified via the National Certification and Accreditation Information Public Service Platform (cx.cnca.cn) or by scanning the QR code in the upper right corner.

Template for the Self-Declaration of Conformity for China Compulsory Certification Products

(Applicable to Authorized Representative of Overseas Manufacturers)

Self-Declaration No.:

(Manufacturer Name) (Manufacturer) and (Name of the Authorized Representative) (Authorized Representative) hereby acknowledge the requirements of the Compulsory Certification Implementation Rules — Self-Declaration of Conformity and the relevant product-specific CCC implementation rules, and assume full legal liability for this self-declaration.

(Manufacturer Name) (Manufacturer) and (Name of the Authorized Representative) (Authorized Representative) hereby declare that the following products have been evaluated by appropriate conformity assessment methods in accordance with the requirements specified in the Compulsory Certification Implementation Rules — Self-Declaration of Conformity and the relevant product-specific CCC implementation rules, and that they comply with the requirements of the applicable standards. From the date of signing this declaration, the products manufactured and sold will continuously comply with the following standards and implementation rules. The manufacturer and the authorized representative will keep the technical documentation relating to this self-declaration for at least 10 years, will use the CCC mark correctly, and will promptly update the technical documentation and submit the product change information if the product or its conformity information changes.