Medical network - April 6, 2017 February 16 to 17, the supervision and administration of medical devices nationwide conference was held in Beijing. It is in the meeting, put forward a very important thing. 

 

According to the website of state administration of drug safety, established in 2017 at the meeting in the work of supervision and administration of medical devices contains a task: 

 

"To promote medical equipment special provisions in the pharmaceutical administration law revision content, improve medical device regulatory legal hierarchy." 

 

In addition, on shortly before a meeting, a deputy director of the administration of drug safety equipment company in summary post-marketing surveillance work of medical equipment in 2016, there are also mentioned "actively cooperate with the pharmaceutical administration law of medical apparatus and instruments special provisions revision". 

 

Medical apparatus and instruments into the pharmaceutical administration law can be bound to do this. 

 

Regulations for medical devices industry, at present, there are in the form of decree of the state council promulgated the regulations on the supervision and administration of medical devices, it is a state administrative regulations; Has promulgated in the form of drug safety administration for the medical equipment the measures for the supervision and administration of production, the measures for the supervision and administration of medical instrument management, the medical equipment using the measures for the administration of quality supervision and the classification rules of medical equipment and so on, these are the administrative rules. 

 

Food, however, there are "food safety law of the People's Republic of China, drugs with the pharmaceutical administration law of the People's Republic of China, it is by the standing committee of the National People's Congress examined and approved, enacted by national presidential order form. In the administration of drug safety regulation scope, the medical equipment does not have this kind of top level, representing the will of the state special laws. 

 

However, if the medical equipment is also included in the pharmaceutical administration law, so the industry regulation is to rise to the highest legal level. With "national will" endorsement, reasonable regulatory steps can upgrade. And for the units and individuals for medical devices industry, the same behavior, the illegal and irregular situation is greatly different, the former is a crime, the latter only administrative penalties. 

 

Since the pharmaceutical administration law enacted, has been revised more than once, the current version of April 24, 2015 revision. 

 

In August 2016, the drug safety administration issued the about comprehensive implementation opinions to strengthen the construction of the food and drug supervision system of the rule of law, hereinafter referred to as "opinions", which put forward again, actively promote the pharmaceutical administration law revision. 

 

Is again one of revision background, the current research and development of the pharmaceutical administration law heavy production light, encourage innovation is not enough; In addition, the penalties for illegal and criminal behavior is not enough, there are illegal link difficult problems such as low cost, the execution. A similar problem, is also in the medical equipment industry. 

 

Is presented in this paper, "opinion" on the revision of the schedule, is "strive to the end of 2016 will revise the draft submitted to the review of the state council", by 2020, food, medicine, medical equipment, cosmetics laws and regulations system revision tasks completed. 

 

The pharmaceutical administration law revision again, and is now under way, and medical devices, special provisions incorporated into whether is implemented in the revision, it remains to be seen.