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Laws & Regulations - Medical Devices - Provisions on Medical Device Standards
Provisions on Medical Device Standards
 
2012/3/20 14:37:01Source: Hits:

Chapter I General Provisions

Article 1 The Provisions are formulated with the view to strengthening medical device standard work and ensuring the safety and effectiveness of medical devices in accordance with the Regulations for the Supervision and Administration of Medical Devices.

Article 2 All organizations or individuals engaged in the development, production, distribution, use, supervision and administration of medical devices within the territory of China shall comply with the Provisions. 

Article 3 Medical device standards encompass national standards, industry standards and registration product standards.

1.     The national or industry standards refer to those standards of which the technical requirements of the products shall be standardized nationwide;

2.     The registration product standards refer to those standards set by manufacturers to ensure safety and effectiveness of the products; and upon application for product registration, they shall be reviewed by the drug regulatory departments at the level of municipalities consisting of districts or above, in accordance with relevant requirements in the national and industry standards.  

Article 4 The State shall adopt an incentive system for the medical device standard work.

Chapter II Regulatory Authorities for the Standard Work and Their Functions

Article 5 The drug regulatory department under the State Council performs the following functions:

1. to organize the implementation of laws and regulations concerning medical devices, and to formulate principles, policies and provisions concerning the work of medical device standards;

2. to organize the formulation and implementation of programs and plans concerning the work of medical device standards; to guide and supervise the work of medical device standards nationwide;

3. to organize the drafting of the national standards of medical devices; to organize the formulation and promulgation of the industry standards of medical devices;  to review the registration product standards of the import medical devices and of Class III medical devices made in China, in accordance with relevant requirements in the national and industry standards;

4. to supervise the implementation of the medical device standards;

5. to oversee technical committees on standardization of medical devices in various specialties;

6. to organize the conversion of the international standards and to carry out international exchanges of standards;

7. to be responsible for commending and rewarding in the work of standards; to manage funds for the work of standards.

Article 6 The drug regulatory department under the State Council establishes a technical committee on medical device standardization. The technical committee shall provide technical guidance and coordination for the work of medical device standards nationwide and perform the following functions:

1.     to conduct research on the medical device standard system and to submit proposals with respect to the policies on the work of medical device standards and the program for projects of standards;

2.     entrusted by the drug regulatory department under the State Council, to examine the national and industry standards of medical devices and to review the registration product standards of import medical devices and Class III medical devices made in China;

3.     to guide and coordinate the work of technical committees on standardization of medical devices in every specialty;

4.     to carry out training, publicity, technical guidance about the work of standards as well as academic exchanges of standards home and abroad;

5.     to circulate information about the medical device standard work.

Article 7 The assignments of technical committees on standardization of medical devices in every specialty established by the State:

1.     to publicize and implement laws, regulations, principles and policies regarding the work of standards;

2.     to submit proposals for the programs and plans with respect to the establishment, revision and research project of the national or industry standards of medical devices in every specialty; and to conduct research on medical device standards;

3.     to formulate and revise the national and industry standards and to collate, check and edit the standards to be submitted for approval;

4.     to provide technical guidance on the work of medical device standards; to assist the drug regulatory authorities at various levels to solve technical problems arising in the implementation of standards;

5.     to collect and collate materials relating to medical device standards and to establish the technical files of the medical device standards in the specialty concerned;

6.     to promote publicity and implementation of the national and industry standards of medical devices and to develop academic exchanges in the field; to assist in the training of the personnel engaged in the work of standards.

Article 8 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall fulfill the following duties within their respective jurisdiction:

1. to implement laws, regulations, principles and policies concerning the work of medical device standards;

2. to supervise the implementation of medical device standards within their jurisdiction;

3. to re-examine the registration product standards of the medical devices produced within jurisdiction; to conduct the preliminary examination of the registration product standards for Class III medical devices made within their jurisdiction;

4. to guide and coordinate the drafting of the national and industry standards as entrusted.

Article 9 The drug regulatory authorities of municipalities consisting of districts are responsible for reviewing the registration product standards for Class I medical devices within their jurisdiction.  The drug regulatory authorities of municipalities consisting of districts or counties (cities at county level) are responsible for supervising and examining the implementation of the medical device standards within their jurisdiction.

Chapter III  Establishment and Issuance of National and Industry Standards

Article 10 The organization drafting the standards shall conduct scientific verification and technical analysis of the requirements, experimental methods and testing procedures of the standards and properly summarize the verification; they shall prepare the draft version of the s

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