Faster Process for Medical Devices Access to the Chinese Market

May 11th 2017, CFDA issued a policy ‘About Encouraging Medicines and Medical Devices Revolution, Speed Up the Selling Audit Process of New Medical and Medical Devices Regulations (first draft)’. CFDA encourages publics to make suggestions before May 25th 2017 through Email (yhzcszhc@cfda.gov.cn). International companies can also contact us by elaine@cirs-group.com or phone number：57187206559 for more information. The deadline is June 10th 2017.
Main Content:
1. Faster the audit of the necessary clinical medical device

Under emergency situation, like life-threatening diseases without efficient medicines or medical devices, preliminary studied or middle stage studied medical devices that have curative effect can go to the market.
Applicant should make risk control plan and follow the instructions of the audit regulation.
National support scientific studied medical devices have priority pass going to the market.

2. Support Orphan Diseases medical device research.

Orphan Diseases medical device researching applicants can reduce or waive the clinic tests
International Orphan Diseases medical devices that already going to the market in their own countries can be sold in China before submit the supporting research to CFDA.

3. Upgrade the medical devices audit policy.

Specialists of clinical medicine, clinical diagnosis, mechanical engineering, material engineering and biomedical engineering are responsible for the innovated medical device audit.
Establish project management system. Applicants cannot privately contact the auditors, communication meeting instead.

Establish senior specialist consulting committee system. For the controversial problems, senior specialists will have public trial with both audits and applicants. Senior specialist consulting committees will publish the audit results and have the social supervision.

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