(Promulgated by Order No.65 of the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China on 23th June, 2004; Revised in accordance with Order No.61 of the State Administration for Market Regulation of the People’s Republic of China on 29th September, 2022)
Chapter I General Provisions
Article 1 The Measures are formulated in accordance with the provisions of the “Regulations of the People's Republic of China on Certification and Accreditation” (hereinafter referred to as “the Regulations”) in order to standardize the administration of China Compulsory Certification bodies and laboratories, make rational use of social resources, and ensure the effective implementation of the China Compulsory Certification system.
Article 2 For the purposes of these Measures, China Compulsory Certification bodies and laboratories refer to the certification bodies and laboratories that engage in China Compulsory Certification and related activities.
Article 3 These Measures shall apply to the designation and supervision of China Compulsory Certification bodies and laboratories within the territory of the People's Republic of China.
Article 4 The State shall implement a designation system to China Compulsory Certification bodies and laboratories.
Article 5 The State Administration for Market Regulation shall be responsible for the establishment, implementation, and supervision of the designation system for China Compulsory Certification bodies and laboratories.
Article 6 China Compulsory Certification bodies and laboratories shall meet the conditions and competence required by the Regulations and other laws & administrative regulations, and may engage in China Compulsory Certification activities and/or testing activities related to China Compulsory Certification only after being designated by the State Administration for Market Regulation.
Article 7 The designation of China Compulsory Certification bodies and laboratories shall follow the principles of rational use of resources, actual needs, fair competition, openness, impartiality, convenience, and effectiveness.
Article 8 Where a certification body and a laboratory belong to the same legal person, their qualifications to engage in China Compulsory Certification and certification-related testing activities shall be designated separately.
Chapter II Conditions for Designation
Article 9 A certification body applying to engage in China Compulsory Certification activities shall meet the following conditions:
(1) It shall be established in accordance with the provisions of the Regulations, with at least two years of certification experience in relevant field, or having issued at least 20 relevant product certification certificates;
(2) It shall conform to the general requirements for the technical competence of certification bodies specified in the national standards;
(3) It shall have no adverse records within the six months immediately preceding the application;
(4) The legal nature, property composition and organizational structure of the organization shall ensure the objectivity and impartiality of its compulsory certification activities;
(5) It shall possess the technical and managerial competence necessary to engage in China Compulsory Certification activities in an impartial, independent, and effective manner;
(6) It shall possess testing and inspection resources required for engaging in China Compulsory Certification activities that can be independently allocated and used, and shall have certification personnel and stable financial resources as required by the Regulations, and commensurate with the tasks of China Compulsory Certification.
Article 10 A laboratory applying to carry out testing activities for China Compulsory Certification testing (hereinafter referred to as “laboratory”) shall meet the following conditions:
(1) It shall have the basic conditions and competence required by laws and administrative regulations, and have been accredited in accordance with the law;
(2) It shall have testing experience in the relevant fields, having engaged in testing activities for at least two years or having issued at least 20 testing reports in the relevant fields;
(3) It shall conform to the general requirements for the technical competence of laboratories as specified in the national standards;
(4) It shall have no adverse records within the six months immediately preceding the application;
(5) The legal nature, property composition and organizational structure of the organization shall ensure the impartiality and independence of its testing activities;
(6) It shall possess all equipment and facilities necessary for conducting the corresponding testing activities for compulsory certification, or have been authorized by the owner of the relevant equipment and facilities to use them independently;
(7) The testing personnel shall have received the education and training necessary for undertaking the corresponding product certification testing activities, master the requirements of relevant standards, technical specifications and the compulsory certification implementation rules, and possess the necessary product testing capabilities.
Chapter III Designation Procedures
Article 11 The State Administration for Market Regulation shall propose a designation plan in accordance with the specific requirements and implementation needs of the China Compulsory Certification system. The designation plan shall include: the activity fields and number of organizations to be designated, the scope of products, the requirements for organizations applying for designation, the designation procedures and relevant time frames, and the composition of the Expert Assessment Committee (hereinafter referred to as the “Expert Committee”).
Where the designated activity fields involve relevant departments of the State Council, the State Administration for Market Regulation shall seek the opinions from such departments on the relevant designation proposals.
Article 12 The State Administration for Market Regulation shall publish the designation plan and other relevant information by means of a written announcements and its official website.
Article 13 A certification body or laboratory applying to engage in China Compulsory Certification activities (hereinafter referred to as the “applicant”) shall, in accordance with the requirements of the designation plan and other relevant information, submit a written application to the State Administration for Market Regulation and provide the relevant supporting documents.
Article 14 The State Administration for Market Regulation shall, within 10 working days from the date of accepting the application, review the written materials submitted by the applicant in accordance with the provisions of Articles 9 and 10 of these Measures, formulate preliminary review opinions, and provide feedback on such opinions to the applicant. Where the applicant meets the preliminary review requirements, the case shall be submitted to the Expert Committee for assessment.
Article 15 Relevant departments under the State Council, industry organizations, enterprises, accreditation bodies, certification bodies and other technical organizations may recommend candidates for the Expert Committee to the State Administration for Market Regulation. The State Administration for Market Regulation shall determine the Expert Committee members according to the different assessment subjects and fields, and form the corresponding Expert Committee.
Article 16 An Expert Committee shall generally consist of 7 to 13 members, and shall be an ad hoc temporary organization responsible for the assessment of applicant.
Upon completion of the assessment work, the Expert Committee shall be dissolved.
Article 17 A member of the Expert Committee shall meet the following conditions:
(1) Have good professional knowledge and professional ethics;
(2) Hold a senior level of technical title or equivalent technical qualifications;
(3) Be familiar with the current situation of the relevant industry, the regulatory systems for the relevant products, and the allocation and distribution of technical organization resources.
Article 18 The Expert Committee shall assess the applicant through by means of meetings, hearings, document review, etc. If necessary, the Expert Committee may recommend that the State Administration for Market Regulation organize an on-site assessment of the applicant.
Where a member of the Expert Committee has a conflict of interest with the applicant (including where the applicant organization employs the member), such member shall withdraw.
Article 19 The Expert Committee shall assess the applicant , taking full account of factors including the characteristics of development in the relevant industry, the distribution of production enterprises, and the effective linkage of the certification system with other regulatory approaches, so as to ensure the effective implementation of the certification system, rational use of resources, and convenience for certification applicants.
The assessments shall take into account the technical competence and the relevant reputation and credibility of the applicant, and shall reach a scientific, reasonable and accurate assessment conclusions on the basis of cost-effectiveness analysis.
The Expert Committee shall reach its assessment conclusions by a two-thirds majority vote by secret ballot.
The lead time of the assessment by the Expert Committee shall not exceed 30 working days.
Article 20 The State Administration for Market Regulation shall, within 10 working days, make the designation decision on the basis of the assessment conclusions reached by the Expert Committee and in accordance with the principles set out in Article 7 of the Measures. In special circumstances where an extension is necessary, the time limit may be extended to 15 working days.
Where the designated business fields involve relevant departments under the State Council, the State Administration for Market Regulation shall make the designation decision after seeking the opinions of relevant departments.
Article 21 The State Administration for Market Regulation shall, within 10 working days of the date of the designation decision, publish on its website a list of the designated China Compulsory Certification bodies and laboratories, along with their specific designated activity scope.
Article 22 Where an applicant has an objection to the designation decision, it shall submit an appeal or complaint to the State Administration for Market Regulation within 15 working days from the date of publication of the designation list.
The State Administration for Market Regulation shall be responsible for handling matters relating to the appeals and complaint.
Chapter IV Code of Conduct
Article 23 China Compulsory Certification bodies and laboratories designated by the State Administration for Market Regulation (hereinafter referred to as “designated certification bodies and laboratories”) shall, within their designated scope, provide services to certification applicants in accordance with the basic certification requirements and certification rules, and shall not transfer the designated certification and testing business, directly or in disguised form.
Article 24 Designated certification bodies and laboratories shall formulate management systems and procedures to clearly distinguish compulsory certification & testing activities from voluntary product certification & commissioned testing activities, and shall not use their designation to conduct voluntary product certification and testing activities.
Article 25 Designated certification bodies shall strictly distinguish between compulsory certification activities and voluntary product certification activities in their external publicity.
Article 26 Designated certification bodies shall enter into written agreements with designated laboratories, specifying the respective rights, obligations and legal liabilities of each party, and shall ensure that the testing activities of the laboratories they use comply with the state’s compulsory certification requirements and certification rules, and that the laboratories they use (including those under the same legal person) enjoy equal rights and assume equal obligations.
Article 27 Where a designated certification body and a designated laboratory are the same legal entity, the designated organization shall formulate relevant management systems and ensure their continued effective operation, guarantee the independent implementation of certification and testing activities, and ensure that certification and testing personnel carry out their activities independently.
Article 28 Designated certification bodies and laboratories shall conduct China Compulsory Certification activities within their designated scope, ensure the provision of timely and effective certification and testing services for certification applicants, and shall not discriminate against or make difficulties for certification applicants, nor seek improper gains.
Article 29 Designated certification bodies and laboratories that engage in international mutual recognition activities shall do so, in accordance with the law, within the framework of international mutual recognition agreements concluded by the State Administration for Market Regulation or authorized departments under the State Council.
Article 30 Designated organizations shall, in accordance with the provisions and requirements of the State Administration for Market Regulation, provide information on China Compulsory Certification and testing in a timely manner, and shall cooperate with the market regulation authorities in their supervision and inspection of China Compulsory Certification.
Chapter V Supervision and Inspection
Article 31 The State Administration for Market Regulation shall conduct regular supervision and inspection of the designated certification bodies and laboratories once a year.
Article 32 Designated certification bodies and laboratories shall submit their annual work reports on China Compulsory Certification activities for the preceding year to the State Administration for Market Regulation by February 15 of each year. These annual work reports shall include internal audits and management reviews. They shall also respond to inquiries from the State Administration for Market Regulation on relevant matters.
Article 33 The State Administration for Market Regulation shall conduct unscheduled investigations into the quality of certification and testing work performed by designated certification bodies and laboratories, and shall solicit opinions and suggestions from relevant certification applicants and certificate holders.
Article 34 The State Administration for Market Regulation shall organize peer reviews of designated certification bodies and laboratories with respect to their technical competence, service quality, work efficiency, professional ethics of staff, and compliance with basic certification requirements and certification rules, and shall publish the results of such reviews.
Article 35 The State Administration for Market Regulation shall conduct targeted spot checks on the certification and testing activities of designated certification bodies and laboratories, as well as on their certification results, and shall publish the results of such spot checks.
Article 36 Any organization or individual may report any illegal or non-compliant act committed by designated certification bodies and laboratories or in the designation process to the market regulation authorities.
Chapter VI Penalties
Article 37 Where a designated certification body or laboratory falls under any of the following circumstances, it shall be ordered to rectify the situation and fined imposed not less than 20,000 yuan but not more than 30,000 yuan:
(1) It lacks of necessary management systems and procedures to distinguish compulsory certification and testing activities from voluntary product certification and commissioned testing activities;
(2) It utilizes compulsory certification activities to publicize voluntary product certification activities;
(3) It fails to provide timely and effective certification or testing services to certification applicants; intentionally delays such services; or discriminates against or causes difficulties for certification clients, and seeks improper gains therefrom.
(4) It fails to cooperate with law enforcement supervision and inspection activities and refuses to provide relevant information;
(5) It fails to submit annual work reports or provide information on compulsory certification and testing as required.
Article 38 Where a designated certification body or laboratory no longer meets the conditions for designation, the State Administration for Market Regulation shall withdraw its designation.
Article 39 Where a designated certification body or laboratory has its designation withdrawn because of unlawful acts such as issuing false certificates, it shall not apply for designation within three years from the date of withdrawal.
Article 40 For other acts violating the provisions of the Regulations, penalties shall be imposed in accordance with the relevant provisions of the Regulations.
Chapter VII Supplementary Provisions
Article 41 The interpretation of these Measures shall be the responsibility of the State Administration for Market Regulation.
Article 42 These Measures shall come into force on August 1, 2004.