Medical network - on March 28, 2016, the food and drug supervision administration regulations on the supervision and administration of medical devices, in accordance with the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44), continue to further proceed with the review of medical equipment examination and approval system reform, further strengthen the supervision and management of the medical device registration, increase the intensity of field authenticity verification and random sampling, improving the quality and efficiency of the review of medical device registration approval. 

 

A, medical device registration work 

 

(a) medical device registration management regulations system gradually improve 

 

Issued the medical equipment quality control standard for clinical trials (state food and drug supervision administration Health and family planning commission of the People's Republic of China order no. 25), the generic names of medical equipment naming rules, the state food and drug supervision administration makes no. 19), the medical equipment examination and approval procedures for priority (state food and drug supervision bureau announcement no. 168, 2016), clinical trials in the from of the second category of medical equipment directory (the second) "and" from clinical trials of class iii medical devices directory (the second) "(the state food and drug supervision bureau announcement no. 133, 2016). 

 

The above regulations and normative documents and revising work marks China's medical device registration management regulations system gradually improve, provides the system safeguard for the medical device registration management, as well as the orderly work of medical equipment enterprise registration declaration provided the good law basis. 

 

(2) review of examination and approval system reform deepening of medical equipment 

 

Founded in 2016, the food and drug supervision administration of the medical reform office for examination and approval of the review, formulated in 2016 reform task breakdown, urge the instruction reform work, the various tasks in order to promote reform. 

 

1. The food and drug supervision administration of medical devices technical review center to establish and perfect the system of review of the quality management system and files, release the implementation of the medical device registration code for review of quality management, expanding the scope of the project team review, to continue registration separate queue, specifications continue registration examination requirements, improve communication system, standardize the expert advice, improve the efficiency of the review. 

 

2. According to the review of reform of examination and approval requirements, promote the reform of classification management, complete the catalogue of medical device classification (draft) ", for public opinion, set up the professional medical device classification technology committee. 

 

3. Actively promote the standard system revision of medical equipment, determine the medical electrical equipment Part 2: light ion beam, the basic security and basic performance special requirements of medical electrical equipment such as 106 standards for medical devices industry plan, examination and release of surgical implants, disinfection equipment and so on 250 medical device industry standards, including compulsory standards 48, voluntary standards, 202 and released one standard revision. 

 

4. Release the second batch of directory from clinical trials of medical apparatus and instruments, on 267 kinds of the second category of medical equipment, 92 kinds of class iii medical devices, total 359 species of medical apparatus and instruments product exemption from clinical trials, there are 15 kinds of in-vitro diagnostic reagent products, it is also the first time in vitro diagnostic reagent products listed in the from conducting clinical trials in the directory. 

 

5. Clinical trials authenticity random strength increasing. 2 batch of medical instrument clinical trial supervision and inspection organizations, extraction of 20 companies for 20 registration project, involving, 40 clinical trial institution to check for eight on the authenticity of registration, make will not be registered, within one year from the date of shall not be registered shall not accept the decision again. A total of 122 companies active withdrew 263 for medical device registration. ShengJu also actively carried out the second category of medical devices clinical trial supervision and spot checks. 

 

Through the supervision and inspection, to strengthen the legal consciousness of the applicant and the clinical test units, the good faith consciousness, responsibility consciousness and quality consciousness, effectively regulate medical instrument clinical trial process, hit the fraud behavior, has played a huge deterrent. 

 

6. Provincial food and drug regulator, and constantly strengthen the review at the provincial level for examination and approval work, improve the capacity to vigorously promote the review for examination and approval system reform. Part ShengJu issued for innovation of the second category of medical equipment special priority measures for examination and approval, optimize and simplify the procedure of the second category of medical device registration, has 14 provinces to implement the system of registration fee. 

 

On December 29, 7.2016 years to complete the part about adjusting the decision of the administrative examination and approval procedures for examination and approval matters in the medical device "(draft) publicly, and for public opinion. 

 

(3) strengthen the supervision and administration of medical device registration work 

 

2016 revised and released the magnetic therapy products, dental implant (system), absorbable sutures and other technical review 52 medical device registration guidelines, including 30, revision of 22. Actual situation, in view of the present medical equipment development, issued the network security of medical equipment technical guiding principles effectively unified examination requirements, enhance the level of the effectiveness of product safety, review. At the same time, technical review and deployed 33 medical device registration guidelines writing projects. 

 

Continue to strengthen the ability of medical apparatus and instruments for examination and approval of the review at the provincial level to evaluate, improve the ability to review the examination and approval to evaluate index, on the basis of the provincial inspection organization to the scene to evaluate 10 ShengJu. Site assessment assessment, extract the file into the on-site review, and analyze the common problems summary, strongly promote the provincial food and drug regulators medical device registration management level of ascension. 

 

Second, the medical device registration to accept the situation 

 

In 2016, the food and drug supervision bureau received medical device registration, the continuation of an application regarding the change registration and licensing item 8920, compared with 2015 registered to accept the project reduced by 5.1%. 

 

(a) the overall situation 

 

In 2016, to accept the third class medical device registration in 3007, to accept the 5913 items for import medical instrument registration. 

 

According to distinguish, registration type for medical device registration, 5920, 3000 items for in vitro diagnostic reagents registration. 

 

According to the registration form, registration for the first time 1612 accounted for 18% of all applications for registration, continuation of 5402 accounted for 61% of the total registration application for registration, licensing items for change registration 1906 accounted for 21% of the total application for registration. Registration form proportion is as shown in figure 1.