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New "Supervision and Regulation of Medical Devices" for public comment
Published:2010-10-20 10:06:42  Read:2380

After 4 years developing the new changes, "Supervision and Regulation of Medical Devices", the official surface. The State Council Legislative Affairs Office has officially released the latest version of the "Supervision and Regulation of Medical Devices" (the "new" regulations ""), and online public comment.
Compared to the current 2000 edition of the "Regulations", the new "Regulations" for the first time the medical device production and operation permits, production quality, maintenance and repair, product recalls and exit, pricing and advertising, the whole process from production to use into the scope of management .

"Economic medicine" reporter has learned that the new version of the "Regulations" in regulation on the height and breadth of the industry are generally given a higher rating, and said he expects the introduction of new "regulations" in more detail under the framework of supporting policies and implementation details .

International market standards and regulations

Indeed, with the international medical device market in recent years, rapid development and continuous improvement of medical standards, industry specifications for medical equipment and scientific requirements of the market has become increasingly urgent. Have been implemented a decade of current 2000 edition of the "Regulations", is clearly difficult to meet the requirements of the development of market standardization and more difficult to effectively ensure the sustainable and healthy and orderly development of the market, therefore, amended the regulations promulgated to implement the new demands of industry for many years already. Beginning in 2007, the relevant state departments have started on the 2000 edition of the "Regulations" be amended.

"Overall, the new version of the" Regulations "have to consider all aspects of a more comprehensive, and clearly put forward the 'state should encourage research and innovation in medical devices, medical devices to promote the popularization and application of new technologies, and promote the development of the medical device industry ', this sentence can be written into the regulations, instructions for medical devices is a very important development. "expert Li Dongcen medical device technical regulations on the new version of the" Regulations "case evaluation.

This reporter has learned, the new "regulations" in the 2000 edition of the "Regulations" made on the basis of a more substantial amendments to specific regulations to increase from the original 48 to 88, which, especially for medical device product management, production management, feed export management, adverse event monitoring and recall, and management, use, ad management, and individual chapters are presented in detail the requirements and specifications.

In product management, new "Regulations" required the implementation of the first class of medical devices record management, the second and third class medical device to implement registration and management, and also the application for a variety of products and requirements were clearly defined; In the production management, the new "regulations" require the production of medical devices shall practice a licensing system for production and qualification of medical devices, production application procedures, product quality management system, content, product descriptions and commission processing and other aspects in detail requirements; in the import and export management, the new version of the "Regulations" in addition to filing and registration of products for import and export regulations, but also clear the technical approval of import and export products, requirements and approach.

Furthermore reporters also found that new "regulations" for the first time the state will establish a separate clear medical device adverse event monitoring and recall system.

New version of the "Regulations" that the State will establish a medical device adverse event monitoring system, collection, analysis, evaluation, control, medical device adverse events, the establishment of medical device product recall system; also requires manufacturers of medical devices should be on its sale of medical devices tracking, re-evaluation, collecting adverse event information and timely investigation, analysis, treatment; in certain circumstances, the state will have a registered medical device organizations re-evaluation.

"China's current food and drug products for the monitoring and recall system has been gradually improving." Sichuan Provincial Food and Drug Administration, former Director, Policy and Regulation Department, said Song Min Xian, China's medical device market with increasing demand for expansion and development of the industry matures, Medical Device Adverse Event Monitoring and product recall has also been very pressing, although there are many provinces and municipalities have formulated the relevant local laws and regulations, but more importantly, the unity of national level documents are still vacant.

"In terms of height or width of view, the new" Regulations "and the development of medical devices in Europe and America are more mature and advanced countries have been full integration of policies and regulations." Li Dongcen case considered.

Enterprises pay more attention to supporting detail

The reporter found, industry experts and business executives on the new "Regulations" draft given a higher rating, but we also hope is in the same direction on the basis of maintaining a more practical operation of guidance supporting policies and rules.

"The general framework of the idea has been very clear, is now worried about supporting the implementation of specific rules and can persist in the direction of the larger framework," an unnamed official told business reporters: "The developed countries, regulatory philosophy based on the premise of trust in business and industry, while China's regulatory philosophy is different. This concept of different, you may make in the following supporting policies to enterprises on the part of the program causing unnecessary losses, such as up the processing time is too long, and complicated process, which is the most concern is related to the "Regulations" the key to effective implementation. "

Li Dongcen also believes that to ensure then to be implemented, including medical device GMP management, product registration management practices and management methods such as classification regulations including, in the management of scientific and reasonable structure to maintain with the new "Regulations" the concept of consistency , will be the next focus of the content to be considered.

The reporter also learned that, as the domestic medical equipment industry developed areas, the Shenzhen Association of Medical Device Industry recently specialized business version called the "Regulations" draft for discussion. Journalists in its recommendations submitted to the State Council Legislative Affairs Office to see the full text, new business, "Bill," the operational details of the relevant provisions of the proposed amendments, the same time, new "Regulations" the general idea of general support and direction.

One of the full text of that proposed for the new version of the "Regulations" Article XII, Article XIII, the proposed increase "technical review should be completed within the stipulated time, technical review process should be publicized its progress," and do not meet requirements conditions, in addition to the reasons shall be written, the proposed increase "does not meet the one to inform all the content." The Association believes that the current technical review of the product and the process is closed too long, which influenced the new product market is not conducive to innovation and development, if it binds the review time and the process will help to improve technical review of the efficiency and increase the transparency of the review process.


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