8th November, 2017
On October 1st, China issued “A Reformed Examination and Approval System of CFDA to Promote Drug and Medical Device Development and Innovation” (hereinafter referred to as "Innovative Opinions"), including a number of important regulation amendments. In order to be compatible with the "Innovation Opinion", the China Food and Drug Administration (CFDA) needs to amend the “Regulations for the Supervision and Administration of Medical Devices” (hereinafter referred to as “Supervision and Administration Regulation"), and issued an amendment draft in October 31st to seek public opinion.
The purpose of the draft is to amend the clauses in the Supervision and Administration Regulation which are in conflict with the clauses of the Innovation Opinion, and to consummate the relevant regulations.
The major amendments are as follows:
(I) Perfect the system of license holder of medical devices
1. CFDA would require the conditions of the applicants, and the relevant obligations that shall be fulfilled;
2. The applicants can manufacture / manage the products by themselves or entrust other enterprises to produce / manage their products;
3. CFDA would add the stipulation for the domestic agent of the foreign manufacturers. CFDA would clearly list the conditions and obligations of the agent, and add the corresponding legal provisions.
(II) Reform of Clinical Trial Management
1. Within a certain period of time after acceptance of the clinical trial application, if the food and drug regulatory authorities do not give negative or doubtful comments, it means that the authorities agree with this clinical trial plan, and the registered applicant can carry out the clinical trial in accordance with the submitted plan;
2. The clinical trial data obtained from overseas centers, which are in compliance with the relevant requirements for the regulation of Chinese pharmaceutical medical devices registration, can be used for registration in China; moreover, for the medical devices for the treatment of life-threatening diseases without established effective therapy, after the primary reviewing, the clinical trial can be expanded to other patients in the clinical trial institution, and the safety data can be used for registration;
3. CFDA would summarize the experience of surveillance of medical device, and provide a clear management requirement of the clinical trial evaluation
(III) Speeding Up of the Listing Review and Approval
1. If the innovative medical devices have no previous approvals (including both domestic and overseas), CFDA will no longer require the local free sale certificate;
2. The inspection report submitted for the registration of Class II and Class III medical device shall be issued by the medical device testing institutions. Right now, it is adjusted to be issued by the applicant's factory reports, or by the inspection agencies having the lab certificate;
3. To support the treatment of rare disease by investing in innovative and novel medical device research and development, foreign-manufactured medical devices that have been approved for listing abroad have a good chance of getting approved for listing in China, as well.
4. The applicants shall improve the listed device with regard to the problems found in the post-marketing surveillance during the license renewal. If the applicants do not carry out the adverse events monitoring, post-marketing research, or re-evaluation, CFDA would consider that the effectiveness and safety of the product are not guaranteed, and would not approve the license renewal.
(IV) Improve the post-marketing surveillance
(V) Enhance the inspection department of medical device on marketing
(VI) The natural person need to undertake the legal punishment
1. If the applicants, production and operation of enterprises, or the institute using the medical device intentionally undergo illegal behaviors or have severe negligence, the legal representative, the major stakeholders, and other directly responsible personnel would be fined at the range of 30% more than 1 times of the annual income.
If you want to understand the complete draft, please refer to the CFDA official website.