95 medical device standards are integrated
On April 6, the State Food and Drug Administration (CFDA) website reported that in order to implement the "Circular of the State Council on Printing and Distributing the Reform Plan for Deepening Standardization Work" (Guo Fa [2015] No. 13) and "The General Office of the State Council The Notice of Standards Integration and Streamlining Work Program (Guobanfa [2016] No. 3) requires that the Bureau has recently deployed relevant mandatory standards integration and streamlining.
Among them, the scope of this integration streamlining includes 95 mandatory national standards for medical devices and 32 revision plans; 385 mandatory industry standards and 79 revision plans. The consolidation and reduction involves 10 mandatory national standards for cosmetics and 13 plans for revision.
It is reported that this work was jointly organized by the Department of Science and Technology Standards of the General Administration of Medicine, the Pharmaceutical Registration Department, the Device Registration Department, the Pharmaceutical Supervision Department, and the Device Supervision Department. The Medical Device Standards Management Center, the Cosmetics Standards Expert Committee, and various medical devices Many units including the Standardization Technical Committee participated.
The standards involved in this work are diverse, with tight integration tasks, tight schedules, high requirements, and heavy workload. The main problems of cross-repetition and contradiction existing in mandatory standards will be solved by means of "abolishing a batch, transforming a batch, integrating a batch, and revising a batch".
Who sets the medical device industry standards?
It is reported that the China Food and Drug Inspection Institute under the CFDA has a Medical Device Standards Management Institute, which has an active medical device standard room, a passive medical device standard room, an in vitro diagnostic standard room, and a standard system research room.
The main responsibilities of the institute include the daily work of the CFDA Medical Device Standards Management Center, the related affairs of the drafting of medical device standards, the organization and coordination of relevant medical device professional standardization technical committees, and the development and revision of medical device standards.
It is understood that the main drafting units of the medical device industry standards are usually the medical device quality supervision and inspection centers directly under the CFDA and scattered in various places, as well as the "medical device inspection centers" (testing institutes and testing institutes) in various provinces and cities, including enterprise organizations. .
For example, among a batch of medical device industry standards announced by the CFDA in November 2015, Shandong Xinhua Medical Device Co., Ltd. mainly drafted two industry standards: "Test Method for Quality of Medical Sterilized Steam" and "Electric Heating Type of Medical Steam Generator" , Guangzhou Daming United Rubber Products Co., Ltd. mainly drafted the industry standard of "Guidelines for the use of GB 7544 in the quality management of rubber condoms and natural latex rubber condoms".
New national standard, new market opportunities
Wei Shaofeng, chairman of the China Medical Device Promotion Association, believes that many industry standards are closely related to the company's product technology, similar to patents, and industry standards are often used by companies as an important means of market competition. Set the threshold for competitors to enter the market, improve the market access conditions, so as to obtain a more favorable competitive environment for themselves.
He believes that the competition of enterprises is divided into three levels, including product competition, patent / standard competition, and brand competition. At this stage, most medical device companies are still in the stage of product competition, relatively junior. This time involves the adjustment and reduction of 95 national standards in the medical device industry. Some enterprises will lose the "access protection", and some other enterprises may obtain new opportunities. For agents, they can focus on the adjusted products that meet the "new national standard" or even the products corresponding to the "new national standard" drafting unit, so as to form their own stronger competitive advantage.
On April 6, the State Food and Drug Administration (CFDA) website reported that in order to implement the "Circular of the State Council on Printing and Distributing the Reform Plan for Deepening Standardization Work" (Guo Fa [2015] No. 13) and "The General Office of the State Council The Notice of Standards Integration and Streamlining Work Program (Guobanfa [2016] No. 3) requires that the Bureau has recently deployed relevant mandatory standards integration and streamlining.
Among them, the scope of this integration streamlining includes 95 mandatory national standards for medical devices and 32 revision plans; 385 mandatory industry standards and 79 revision plans. The consolidation and reduction involves 10 mandatory national standards for cosmetics and 13 plans for revision.
It is reported that this work was jointly organized by the Department of Science and Technology Standards of the General Administration of Medicine, the Pharmaceutical Registration Department, the Device Registration Department, the Pharmaceutical Supervision Department, and the Device Supervision Department. The Medical Device Standards Management Center, the Cosmetics Standards Expert Committee, and various medical devices Many units including the Standardization Technical Committee participated.
The standards involved in this work are diverse, with tight integration tasks, tight schedules, high requirements, and heavy workload. The main problems of cross-repetition and contradiction existing in mandatory standards will be solved by means of "abolishing a batch, transforming a batch, integrating a batch, and revising a batch".
Who sets the medical device industry standards?
It is reported that the China Food and Drug Inspection Institute under the CFDA has a Medical Device Standards Management Institute, which has an active medical device standard room, a passive medical device standard room, an in vitro diagnostic standard room, and a standard system research room.
The main responsibilities of the institute include the daily work of the CFDA Medical Device Standards Management Center, the related affairs of the drafting of medical device standards, the organization and coordination of relevant medical device professional standardization technical committees, and the development and revision of medical device standards.
It is understood that the main drafting units of the medical device industry standards are usually the medical device quality supervision and inspection centers directly under the CFDA and scattered in various places, as well as the "medical device inspection centers" (testing institutes and testing institutes) in various provinces and cities, including enterprise organizations. .
For example, among a batch of medical device industry standards announced by the CFDA in November 2015, Shandong Xinhua Medical Device Co., Ltd. mainly drafted two industry standards: "Test Method for Quality of Medical Sterilized Steam" and "Electric Heating Type of Medical Steam Generator" , Guangzhou Daming United Rubber Products Co., Ltd. mainly drafted the industry standard of "Guidelines for the use of GB 7544 in the quality management of rubber condoms and natural latex rubber condoms".
New national standard, new market opportunities
Wei Shaofeng, chairman of the China Medical Device Promotion Association, believes that many industry standards are closely related to the company's product technology, similar to patents, and industry standards are often used by companies as an important means of market competition. Set the threshold for competitors to enter the market, improve the market access conditions, so as to obtain a more favorable competitive environment for themselves.
He believes that the competition of enterprises is divided into three levels, including product competition, patent / standard competition, and brand competition. At this stage, most medical device companies are still in the stage of product competition, relatively junior. This time involves the adjustment and reduction of 95 national standards in the medical device industry. Some enterprises will lose the "access protection", and some other enterprises may obtain new opportunities. For agents, they can focus on the adjusted products that meet the "new national standard" or even the products corresponding to the "new national standard" drafting unit, so as to form their own stronger competitive advantage.