Major Medical Device Changes In China Introduced by the 2018 Draft Amendment to the “Regulations on the Supervision and Administration of Medical Device”*

Following the issuance of the “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices” by the Central Office of the Communist Party of China and the Office of the State Council on October 1, 2017, the former China Food and Drug Administration2* formulated and published the Amendment to the “Regulations on the Supervision and Administration of Medical Device” (Draft for Public Comments) in October 2017, upon which a further revised draft amendment was announced for public comments from June 26, 2018 to July 24, 2018 (the 2018 Draft Amendment). The 2018 Draft Amendment is believed to be very close to its final version and will have a significant impact on all market players in the medical device industry. The major changes introduced by the 2018 Draft Amendment are summarized as follows: Improve the Market Authorization Holder (MAH) Mechanism Prior to the 2018…

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