CNCA 00C-008-2019 English PDF (CNCA00C-008-2019)

This Rules applies to products that are assessed by self-declaration in China Compulsory Certification catalogue. This Rules stipulates the definitions, self-declaration procedures, conformity information submission and self-declaration requirements, CCC mark, post-market supervision, and responsibilities and obligations of related parties, etc. for the self-declaration assessment method of China Compulsory Certification.

CNCA-00C-008:2019
Attachment
Serial No.: CNCA-00C-008:2019
CNCA-00C-008-2019
China Compulsory Certification Implementation Rules -
Self Declaration
ISSUED ON: DECEMBER 25, 2019
IMPLEMENTED ON: JANUARY 01, 2020
Issued by: Certification and Accreditation Administration of the People's Republic of China
Table of Contents
0 Introduction ... 3
1 Scope ... 3
2 Definitions ... 3
2.1 Producer (manufacturer) ... 3
2.2 Authorized representative ... 3
2.3 Manufacturing enterprise ... 4
2.4 Importer ... 4
2.5 Seller ... 4
2.6 Business user ... 4
2.7 Self-declaration procedure ... 4
2.8 Self-declaration ... 4
2.9 Self-selected laboratory ... 4
2.10 Designated signatory... 4
3 Self-declaration procedures ... 5
3.1 Self-declaration procedures ... 5
3.2 Classification of self-declaration procedures ... 5
4 Conformity information submission requirements ... 7
4.1 System registration ... 7
4.2 Submit conformity information ... 7
4.3 SIGN and submit a self-declaration ... 8
5 Self-declaration change ... 8
6 Self-declaration cancellation ... 9
7 Validity period of self-declaration ... 9
8 CCC mark use requirements ... 9
9 Post-market supervision ... 10
10 Responsibilities and obligations of related parties ... 11
Attachment 1: Technical documentation ... 12
Attachment 2: Compulsory Certification Product Conformity Self Declaration (style) ... 13
0 Introduction
In order to deepen the reform and innovation of the quality certification system, strengthen the main-body responsibility of enterprises, reduce institutional transaction costs, and optimize China Compulsory Certification procedure, by benchmarking the international advanced conformity assessment system, China Compulsory
Certification system, based on third-party certification, adds a self-declaration assessment method. For products in China Compulsory Certification catalogue to which the self-declaration assessment method applies, the producer (manufacturer) shall, in accordance with the requirements of this Rules, complete the
self-assessment and product conformity information submission and apply China Compulsory Certification mark to the products.
1 Scope
This Rules applies to products that are assessed by self-declaration in China Compulsory Certification catalogue.
This Rules stipulates the definitions, self-declaration procedures, conformity information submission and self-declaration requirements, CCC mark, post-market supervision, and responsibilities and obligations of related parties, etc. for the self-declaration assessment method of China Compulsory Certification.
2 Definitions
2.1 Producer (manufacturer)
The enterprise with independent legal personality which designs and produces products or entrusts others to design, produce, and sell in its name/trademark and shall undertake the main-body responsibility for the product quality.
2.2 Authorized representative
The enterprise, legally registered within the territory of China, which is authorized in writing by an overseas producer (manufacturer) to submit product conformity information and submit a self-declaration to the "Compulsory Certification Product Conformity Self-Declaration Information Submission System" (http://sdoc.cnca.cn) on behalf of the overseas producer (manufacturer), works with the overseas producer (manufacturer) to take responsibility for self-declared product safety and quality, and cooperates with market supervision authorities for post-market supervision. An overseas producer (manufacturer) can choose his or her subsidiary, importer, or seller as an authorized representative.
3 Self-declaration procedures
3.1 Self-declaration procedures
3.1.1 The producer (manufacturer), aiming to ensure that its self-declared products continue to comply with the applicable standards for China Compulsory Certification, according to the requirements of this Rules and the corresponding product certification implementation rules, for product characteristics and production processing characteristics, implements internal quality control and establishes factory quality assurance system.
3.1.2 The producer (manufacturer) selects the appropriate type of conformity assessment method (see Article 3.2) to evaluate the conformity of the product and prove that the product continues to meet the requirements of the applicable standards for China Compulsory Certification.
3.1.3 The producer (manufacturer) shall, in accordance with the requirements of Attachment 1 of this Rules, establish technical documentation and keep it properly. From the date of completing the submission of product conformity information, it shall be kept for at least 10 years for future reference.
3.1.4 The producer (manufacturer) and authorized representative (when applicable), for the products that pass the assessment, sign the "Compulsory Certification Product Conformity Self Declaration" (see Attachment 2 for the style) and complete the reporting of product conformity information.
3.1.5 The producer (manufacturer) applies the CCC mark to its self-declared products.
3.1.6 When product design, technical characteristics, related China Compulsory Certification requirements, or self-declaration-related information changes, the producer (manufacturer) and authorized representative (when applicable) shall, based on the changes, supplement the assessment of product conformity and update the self-declaration and product conformity information.
3.2 Classification of self-declaration procedures
The self-declaration procedures, according to different types of conformity assessment methods, are classified into self-declaration procedure A and self-declaration procedure B.
3.2.1 Self-declaration procedure A
The self-declaration procedure A applies for conformity assessment as follows: The self-selected laboratory conducts the type test and issues the type test report. The producer (manufacturer) organizes a self-inspection of its factory's quality 4 Conformity information submission requirements
4.1 System registration
Producers (manufacturers), laboratories and certification bodies involved in self-declaration shall register in the "Compulsory Certification Product Conformity Self-Declaration Information Submission System" (hereinafter referred to as the system) and submit relevant organization information and qualification documents. 4.2 Submit conformity information
4.2.1 In general, producers (manufacturers) and authorized representatives (when applicable) shall submit conformity information as follows:
a) Self-declared product information;
b) Information on the standards the product meets;
c) Type test report;
d) Inspection report of factory quality assurance capability (self-inspection or entrusting a third party);
e) Information about voluntary product certification certificates (when applicable); f) Information about the laboratories and certification bodies (when applicable) involved in the self-declaration and relevant qualification certificates; g) Other materials related to product conformity.
The self-declaration and product information submitted such as product name, model specifications, manufacturing enterprise, producer (manufacturer) shall be consistent with the actual product and covered by the content of type test and voluntary certification (when applicable).
4.2.2 If the producer (manufacturer) entrusts the design and production of products in the ODM mode, the conformity information shall be submitted as follows: a) Self-declared product information;
b) Information on the standards the product meets;
c) Initial self-declaration information;
d) ODM agreement BETWEEN producer (manufacturer) and ODM initial
self-declaration producer (manufacturer) AND manufacturing enterprise;
e) Agreement BETWEEN producer (manufacturer) and ODM initial self-declaration b) The product has changed but the relevant conformity information has not been updated in the system;
c) Other situations where the relevant requirements of China Compulsory Certification are not met.
9 Post-market supervision
9.1 The CNCA is responsible for organizing and implementing the supervision and management of self-declaration and the use of the CCC mark. Market supervision authorities at all levels are responsible for supervising and managing self-declarations and the use of the CCC mark in the regions under their jurisdiction.
9.2 Producers (manufacturers) and authorized representatives (when applicable) shall cooperate with the post-market supervision and be able to provide CCC self-declaration and related information in accordance with the requirements of market supervision authorities. The producer (manufacturer) and authorized representative (when applicable) shall ensure that the seller/business user can also provide or query the self-declaration information of the products it sells/uses. 9.3 When one of the following situations occurs, the producer
(manufacturer)/importer/seller/business user shall stop exit-factory/importing/selling/ using of the self-declaration corresponding products. The system revokes relevant self-declarations and makes them public. For products with self-declarations revoked, producers (manufacturers) and authorized representatives (when applicable), within 6 months, cannot declare self-declarations again. The relevant information of discredit is included in National Enterprise Credit Information Publicity System. a) The self-declaration corresponding product is supervised and spot-tested by the market supervision authorities at all levels and it is proved that there are serious defects and the product safety testing items are unqualified;
b) The self-declaration corresponding product is defective and causes a quality safety accident;
c) Falsification, use unfair means to complete self-declaration and information submission; or there are other behaviors which directly affect the validity of self-declaration;
d) Refuse to accept the supervision-sampling;
e) Other circumstances in which self-declaration shall be cancelled.
9.4 When one of the following conditions occurs, the producer (manufacturer) shall implement rectification and update relevant information. If necessary, producer (manufacturer)/importer/seller/business user shall stop exit-factory/importing/selling/ Attachment 1: Technical documentation
The producer (manufacturer) shall establish technical documentation. The technical documentation shall be able to fully demonstrate that the product meets the requirements for compulsory certification and shall include sufficient risk assessment analysis. The technical documentation shall specify relevant requirements and contain information on product design, production, and use.
Where applicable, the technical documentation shall contain at least the following: 1. Product description (i.e. a comprehensive description of product characteristics such as model specifications, technical parameters, structure, electrical principles);
2. List of key parts/raw materials;
3. Structure diagram;
4. Circuit diagram;
5. Design and production drawings;
6. Product use/operation instructions;
7. List of applicable standards for compulsory certification of product; 8. Type test report;
9. Factory quality assurance capability inspection report;
10. Information, qualifications, and technical capabilities of relevant laboratories or certification bodies, and details of their accreditation status (such as accreditation scope, accreditation body name, etc.);
11. Product change information;
12. Other relevant information.