On May 15, May 15, the state administration of drug administration issued the four major reform policies for public consultation. 

 

Separately: 

 

"Relevant policies concerning the implementation of the whole life cycle management of pharmaceutical medical devices for the innovation of pharmaceutical medical devices"; 

 

"Relevant policies concerning the innovation and protection of innovator's rights and interests of drug medical devices"; 

 

"Relevant policies concerning the reform of clinical trial management of pharmaceutical medical devices for innovation"; 

 

"Relevant policies on encouraging the innovation of pharmaceutical medical devices to improve the examination and approval of new drug medical devices (consultation)". 

 

The four "draft" swords point to the same goal: to encourage innovation in medical devices. 

 

The administration has done a lot of work, and domestic innovation is expected to see great benefits. There are more important initiatives to liberalise, including: 

 

The clinical trials authorities have opened up 

 

"Clinical trial institution qualification instead of filing management. Cancel the clinical trial institution qualification. For clinical trials in medical institutions in the food and drug supervision department designated website after registration for the record, can be entrusted by the applicant to carry out clinical trials. Encourage social capital investment to establish a clinical test units, provide professional service of clinical trials." 

 

-- the clinical trial organization is open to the prospect of breaking existing bottlenecks. But at the same time, the examination of clinical trial data will be strengthened after the filing, so as to maintain authenticity and prevent fraud. 

 

Hospitals and doctors are involved in clinical trials 

 

"Support the medical institutions, medical institutions, medical colleges and universities to participate in clinical trials, conditions and ability of clinical trials should be brought into the medical institution level evaluation, clinical key subject of important indicators. Encourage third rate of medical institution, the provincial level or above undergraduate medical colleges affiliated hospital to undertake clinical trial work. Encouraging the establishment of full-time clinical trial department, medical institutions with professional clinical trial personnel. Encourage clinicians to participate in the activities of pharmaceutical medical equipment technology innovation. To conduct clinical trials of medical personnel in such aspects as higher post, responsibility.it and clinicians alike. Performance wage distribution incentive mechanism, improve the unit guarantee clinical trials researchers income level." 

 

3, the clinical trial review procedure is released 

 

"Should be to the approval of medical apparatus and instruments, before clinical trials must be approved by the applicant and the review meeting after the communication application and acceptance. The review agency 60 working days from the date of acceptance, gave no deny or be deemed to have agreed to review opinion question, the applicant can be submitted in accordance with the plan to carry out clinical trials." 

 

The approval of clinical trials is expected to be accelerated. 

 

Data on overseas clinical trials are released domestically 

 

"Accept overseas clinical trial data. Applicants outside in the clinical trial data, in conformity with the requirements of the relevant Chinese medicine medical device registration after on-site inspection can be used for filing an application for registration in China. The applicant approed for sale in foreign medical apparatus and instruments, in addition to the need for clinical trials to the approval of the third class medical apparatus and instruments, outside submitted when an approed for clinical trial data, can be used as a clinical trial data are used to declare medical device registration in China." 

 

-- it is conducive to the simultaneous listing of innovative medical instruments. 

 

The clinical needs and the scientific and technological innovation medical devices are approved and released 

 

"And there is no effective treatment in treating severe life-threatening disease drugs are of great significance to the medical apparatus and instruments, and other solutions to clinical needs of medicine medical apparatus and instruments, clinical trials early, mid, indicators, curative effect and can predict the clinical value of conditional approal. Encourage innovation drugs and medical equipment research and development, to listed in the national science and technology major projects and national key research and development plans to support innovative drugs and medical devices, to give priority to review for approval." 

 

-- the need for clinical and state-approved scientific and technological innovation medical devices will be accelerated. 

 

Development and approval of medical devices for rare diseases 

 

"Support for rare diseases treatment and medical equipment research and development. By the family planning departments of public health announced catalogue of rare diseases, build system of rare diseases registration. Rare diseases drugs and medical devices the applicant can apply for derate clinical trials, speed up the rare diseases medicine medical apparatus and instruments for examination and approval of the review. For rare diseases listed abroad approved drugs and medical devices, can be conditional approal, listed in the specified period of time after catching up on some related research."