Measures for the Administration of the Supervision and Administration of Medical Device Production

Legal analysis: The Measures for the Supervision and Administration of Medical Device Production were deliberated and approved by the State Food and Drug Administration on June 27, 2014, and promulgated by Order No. 7 of the State Food and Drug Administration on July 30, 2014. The "Measures" are divided into 72 articles in 7 chapters, including General Provisions, Production Licensing and Filing Management, Entrusted Production Management, Production Quality Management, Supervision and Management, Legal Liability, and Supplementary Provisions, which came into force on October 1, 2014.

On July 20, 2004, the State Food and Drug Administration promulgated the "Measures for the Supervision and Administration of Medical Device Production" promulgated by Order No. 12 to be repealed.

Legal basis: Measures for the Supervision and Administration of Medical Device Production of the People's Republic of China

Article 1 In order to strengthen the supervision and management of medical device production, standardize the production behavior of medical devices, and ensure the safety and effectiveness of medical devices, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 Those engaged in the production of medical devices and their supervision and management within the territory of the People's Republic of China shall comply with these measures.

Legal Analysis] The State Food and Drug Administration formulates and supervises the implementation of quality management standards for medical device production. The food and drug supervision and administration department shall promptly publish the relevant information on the production license and filing of medical devices in accordance with the law. Applicants can inquire about the approval progress and approval results; The approval results are available to the public.

Medical device manufacturers shall be responsible for the quality of medical devices produced. If the production is commissioned, the entrusting party shall be responsible for the quality of the medical devices entrusted to be produced. To engage in the production of medical devices, the following conditions shall be met:

1) There are production sites, environmental conditions, production equipment and professional and technical personnel suitable for the production of medical devices; (2) There are institutions or full-time inspectors and inspection equipment for quality inspection of the medical devices produced; (3) The management system for the quality of medical devices; (4) Have the ability to provide after-sales service suitable for the medical devices produced; (5) Meet the requirements of product development and production process documents.

Legal basis] Regulations on the Supervision and Administration of Medical Devices》 Article 1 In order to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry, this article is formulated. Article 2 These Regulations shall apply to the development, production, operation and use of medical devices within the territory of the People's Republic of China and their supervision and management. Article 3 The drug regulatory department is responsible for the supervision and management of medical devices nationwide.

The relevant departments are responsible for the supervision and management of medical devices within the scope of their respective responsibilities.

In order to strengthen the supervision and management of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

The State Drug Administration is responsible for the supervision and management of medical device production nationwide.

The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and management of the production of Class II and Class III medical devices in their respective administrative regions, and are responsible for the supervision and management of the production of Class I medical devices in their respective administrative regions in accordance with their duties in accordance with the law, and strengthen the guidance on the supervision and management of the production of Class I medical devices in their respective administrative regions.

The departments responsible for drug supervision and administration at the districted city level shall supervise and manage the production activities of Class I medical devices in their respective administrative regions in accordance with their duties in accordance with their duties.

Article 6 The professional and technical institutions for the review, inspection, inspection, monitoring and evaluation of medical devices established or designated by the drug regulatory department in accordance with the law shall undertake relevant technical work in accordance with the division of responsibilities and provide technical support for the supervision and management of medical device production.

The Food and Drug Inspection Center of the State Drug Administration organizes the formulation of medical device inspection system specifications and technical documents, undertakes major cause inspections and overseas inspections, and guides and evaluates the quality management system of medical device inspection institutions in provinces, autonomous regions and municipalities directly under the Central Government.

In any of the following circumstances, the original licensing department shall cancel the medical device business license in accordance with the law and make an announcement:

1) Applying for cancellation on their own initiative;

2) The validity period has not been renewed upon expiration;

3) Market entity qualifications are terminated in accordance with law;

4) The medical device business license has been revoked or revoked in accordance with the law;

5) Other circumstances where laws and regulations provide that administrative licenses shall be cancelled.

Legal basis

In accordance with the Regulations on the Supervision and Administration of Medical Devices, these measures are formulated.

Article 2 in the People's Republic of China engaged in medical device business activities and their supervision and management, shall comply with these measures.

Article 3 engaged in medical device business activities, shall comply with the requirements of laws, regulations, rules, mandatory standards and medical device business quality management standards, etc., to ensure that the information in the medical device business process is true, accurate, complete and traceable.

Medical device registrants and record-filing persons can sell them on their own, or they can entrust medical device business enterprises to sell their registered and filed medical devices.

Article 4 According to the degree of risk of medical devices, the operation of medical devices shall be managed by classification.

The operation of Class III medical devices shall be subject to license management, the operation of Class II medical devices shall be subject to record management, and the operation of Class I medical devices shall not require licensing and filing.