The development of the provisions of the basis is: "supervision and management of medical devices regulations" (hereinafter referred to as "regulations") Article 16, that is: the instructions, labeling, packaging of medical devices should be in line with the relevant national standards or regulations. Second, the provisions of the main principles or supervision and management measures to determine:
(a) provides for the review of medical device instructions based on;
(b) specifies the content of the medical device instructions;
(c) specifies that the medical device instructions should be used in Chinese, additional other languages do not qualify;
(d) In addition to reaffirming the "industrial product instructions - General Provisions" national standards. (D) in addition to reaffirming the "industrial products - General Provisions" of the national standard, combined with the characteristics of medical devices, but also provides for "single-use products", "sterilized products", "supporting the use of products (H) provides that the content of the medical device specification shall not be changed without authorization. Third, the provisions of the drafting process and the handling of major disagreements
The provisions of the March 23, 1999 ~ 25, put forward the first draft, and seek the views of the local drug supervision and management departments. After modification and improvement, by August 23, 1999 ~ 27 national "Regulations" supporting regulations seminar, discussion and completion of the third draft. The third draft on September 21 - 23 to seek the views of representatives of state-owned, Sino-foreign equity joint ventures, foreign-funded enterprises, after the preliminary finalized. April 20, 2001 by the Department of the Council, September 28, 2001, the Division of all comrades again revised, and with the Bureau of the Office of the Regulations *** with the revised and finalized for consideration by the Council. November 19, 2001 by the Bureau Council Considered and adopted in principle.
Drafting involved in the main differences and the results are as follows:
(a) on the need to specifically formulate the medical device instructions management regulations. Because there is already a national standard of Instructions for Use of Industrial Products, some delegates believed that there is no need to formulate specific instructions for medical devices. Most representatives believe that because the requirements of the instructions are not clear, will bring misleading, or even mistakes in the use of the link, but also to the release of advertising content to bring a lot of loopholes. The recent problems in the wearing of OK lenses, in which the instructions do not give detailed instructions on contraindications and precautions are also the cause of adverse reactions, is a typical example. In view of the current market problems are mostly related to product specifications, for the current situation of medical devices, in order to strengthen the review of medical device specifications, the need to develop a special medical device specifications.
(ii) some delegates believe that the manual is a general random document prepared by the enterprise itself, can not be regarded as a statutory document. The majority of the delegates believed that the medical device product specification is different from the general industrial product specification, which on the indications and other contents of the enterprise should be made to the social consumers of the statutory commitment. After discussion, from the limitations of the indications in the manual to ensure the safe and effective use of medical devices, while summarizing the problems found in the review of product registration, the main performance of the product on the manual, the scope of application, contraindications, precautions, and other important content in the form of approvals to be confirmed. Provides that the content of the product specification once approved shall not be altered without authorization.
(C) on medical device labeling and packaging marking regulations. Medical device product categories cover a wide range of medical electrical products and biomaterials products, especially disposable medical devices, labeling and packaging identification requirements are different. For the latter, there are specialized industry standards; for the former, the state has made more complete provisions. Therefore, we believe that no further specific provisions will be made here. According to Article 14 of the Regulations: "Medical device labeling and packaging labeling should be consistent with relevant national standards or regulations", we refine the labeling and packaging labeling of medical devices should be consistent with relevant national standards or regulations and the relevant provisions of this regulation. Fourth, the provisions of the regulations to promote the supervision and management of medical devices have substantial significance of the provisions of this supplement to clarify the relevant content of the medical device as a special commodity instructions, strictly determined by experts or the approval authority of the product's function and the consistency of the product function of the merchant's commitment to the consumer, to avoid advertising and other commercial propaganda false, to ensure that the supervision and management of the effective and scientific. It is recommended that the provisions be issued in the form of a director's order. Article 5 The municipal drug supervision and management department is responsible for the administrative region of the production of the first class of medical device instructions for approval; provinces, autonomous regions and municipalities directly under the Central Drug Administration is responsible for the administrative region of the production of the second class of medical device instructions for approval; the State Drug Administration is responsible for the territory of the production of the third class of medical devices, the import of medical devices instructions for approval.
The review of medical device specifications should be reviewed in conjunction with the review of the registration of medical devices, the content of the specifications should be consistent with the relevant content of the registration review. Article 6 The drug supervision and management department of the medical device specification review is based on product standards, product type test results, clinical trial reports and expert review. The approved medical device specification and specification approval shall not be altered without authorization. Article VII medical device instructions should use the national language and writing committee announced the standardization of Chinese characters, can be attached to other languages.