If 2014 is the "regulatory year" of the medical device industry , then 2015 will be the "quality change year" for the medical device industry!
I. 2014: A new medical device regulatory system was formed
In 2014, the "female law" of the medical device industry - "Regulations on the Supervision and Administration of Medical Devices" was finally revised and implemented 14 years after its implementation. It not only revolutionized the regulatory system, but also drastically created a regulatory system. Moreover, the CFDA introduced five departmental regulations on the basis of the implementation of the new "Regulations", accelerating the pace of system restructuring. These regulations are: "Administrative Measures for the Registration of Medical Devices" (Order No. 4); "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" (Order No. 5); "Regulations on the Management of Medical Devices Manuals and Labels" (Order No. 6); "Medical Device Production Supervision and Management" Measures (Order No. 7); "Administrative Measures for the Supervision and Administration of Medical Devices" (Order No. 8).
These regulations further enrich the content of the medical device regulatory system and consolidate the connotation of the medical device management system. In addition, CFDA also issued a series of regulatory documents in the form of notices, announcements, notices, etc., paving the way for the implementation of the new "Regulations" and related regulations in 2015, laying the "last mile" for the implementation of the regulatory system. . It can be seen that in 2014, the speed of system construction with one administrative regulation, five departmental regulations, seven announcements, eight announcements, and five notifications became a veritable “regulation year†in the medical device industry.
Second, 2015: when the medical device management "quality change" is in progress
1. Qualitative change one: segmentation supervision shifts to seamless supervision
The life cycle of medical devices begins at the time of R&D design and ends with the recall. It includes many links such as registration, production, operation, use and monitoring of adverse events. Before the implementation of the new "Regulations", the pre-IPO regulatory system dominated the world. After the implementation of the new "Regulations", the post-listing stage was strengthened and improved due to the establishment of the re-evaluation and recall system. In 2015, it will be the first year of the transition of the regulatory model from segmental regulation to seamless regulation. The Medical Device Classification Rules and the Measures for the Administration of Medical Device Clinical Trial Qualifications are being consulted and will be implemented in 2015.
In addition, the "Measures for the Supervision and Administration of the Use of Medical Devices", "Standards for the Quality Management of Medical Devices", and "Regulations for the Management of Clinical Devices for Medical Devices" will be accelerated in 2015. These management regulations will form another legislative climax in 2015. As a result, we can vaguely see that a strict chain of custody is being formed and substantively binding on the production and operation enterprises and the users. The majority of medical device production and operation enterprises must recognize the impact of this major qualitative change and take effective measures to adapt to this change.
2, qualitative change 2: management weakness to strict responsibility
In 2014, the state vigorously pursued discipline and anti-corruption, and the market environment was purified to a certain extent. At the same time, the relevant departments are also heavily involved in the field of medicine, punishing commercial bribery. Such a megatrend, a large background influences and acts on the medical device industry, and the spirit of reconciliation has been reflected in the revised contents of the new Regulations. Refined punitive measures, strict liability setting, high fines, and various regulatory measures have woven a strict legal network.
No enterprise or all employees should be lucky enough to test the determination of the management department to strictly supervise. Such strict liability is a kind of protection and encouragement for law-abiding and honest enterprises, and it is a warning and supervision for untrustworthy enterprises. Inspired by the signal of “ruling the country by law†as the sole theme of the conference, the Fourth Plenary Session of the 18th Central Committee must not question the country’s determination to implement the rule of law by illegal acts. In 2015, due to the greatly strengthened supervision, the previous management weakness will be replaced by strict liability, and this qualitative change will be fully reflected in the investigation and punishment of illegal cases.
3, qualitative change three: institutional management to open to the market
For a long time, under the misconception of the all-powerful government, the government has done everything to protect the world. So far in the medical device industry, some technical inspection activities are still covered by government affiliated institutions, and relevant qualifications are never open to the market. It has even seriously hindered the growth of market inspection power, and finally affected the healthy development of the industry. Now, under the new concept of social co-governance, the government is no longer omnipotent, but the return of the right to decentralize the government to serve the limited government and serve the government.
Under the influence of this concept, the qualification conditions for medical device clinical testing institutions and medical device testing institutions will be released, and the qualified units in the market will be given corresponding qualifications to allow clinical trials and testing. In 2015, this qualitative change will be reflected in the formulation of the “Qualification Requirements for Medical Device Testing Organizationsâ€. If realized, it will become a big benefit for the medical device industry, greatly promoting and enhancing the vitality of the market.
2014 has passed, and 2015 has come to us. In the new year, it is destined to be an extraordinary year for the medical device industry. The new version of the "Quality Management Standard for Medical Device Manufacturing" (Medical Device GMP) released at the end of 2014 will be implemented on March 1, 2015. Comrades of medical device manufacturers, are you ready?
Gummy Bear,Juicy Soft Candy,Juice Gummy Candy,Fruit Gummy Candy
Montreal Shantou Food Co., Ltd , https://www.montrealsnack.com