Major Changes of 'Medical Device Supervision and Administration Regulation’
Time : 2017-11-06
Author : CIRS Lou
October 31st 2017, CFDA issued the exposure draft of the amendment ‘Medical Device Supervision and Administration Regulation’. CFDA encourages public to make suggestions before November 12th 2017 through Email (firstname.lastname@example.org).
1. Perfect the system of medical device listing authorization holder. It added the article 9 and regulated the requirements and obligations of registrants and filers. Also in article 11, registrants and filers can do the sub-contract production. And the subject in the old regulation is the manufacturer, but the new one changes to be the registrants, filers and manufacturer.
2. The class II and III medical devices can provide the self-test report or authorize the qualified medical devices testing institutions.
3. Accept the oversea clinical trials for the CFDA medical device registration.
4. The class III high risk level medical devices clinical trial approval change from required written permission to implied permission.
5. The oversea unlisted innovated medical devices are not required to submit the oversea listing certificates.
6. The medical devices for the orphan disease and life-threatening diseases without efficient treatment and public health emergencies in urgent need medical devices can have conditional approval.
7. The imported manufactures can submit the self-testing report through the legal representative to the legal representatives’ province, municipality and direct-controlled municipality government food and drug administration.
8. Production conditions change might influence the product safety and effectiveness. The legal representative shall report to the local food and drug administration through the legal representative.
9. The class II medical devices that the safety and effectiveness are guaranteed are not required to be filed for the operation.
10. Shall not operate the old used medical devices and expired, invalid, obsolete medical devices.
11. The imported medical devices that not meet the requirements of medical devices production quality control standard or the self-testing report not confirmed to the regulations, in accordance with law, may make a questioning, rectification within a time limit, suspended the import and sales suspension use, revocation of registration certificate or registration certificate or other penalties.
12. Personal punishment. If medical device registrant, recorder, the production and operation enterprises, applying firms conduct illegal act or gross negligence or illegal behavior and the circumstances are serious, nature or cause serious consequences or other serious adverse social impact, the legal representative, recorder , directly in charge person or other directly responsible persons shall have penalty.