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 Draft Amendment, the term “MAH” was adopted and used in the 2016 “Notice of the General Office of the State Council on the Pilot Plan of the Drug Market Authorization Holder System.” The 2018 Draft Amendment provides for a clear definition of MAH, the entity that obtains from the competent drug supervision authority a medical device filing receipt or registration certificate for sale of the medical device into markets. In addition, the 2018 Draft Amendment adds specific provisions on MAH’s rights and obligations. For instance, MAHs may produce or sell their products or entrust others to do the same; MAHs shall ensure that their quality systems operate effectively and their products satisfy the relevant requirements; MAHs shall submit self-inspection reports to the relevant supervision authority every year; MAHs shall establish a medical device adverse event monitoring system and assume responsibility for the recalling of defective products. In addition, the 2018 Draft Amendment imposes detailed obligations on foreign MAHs’ agents in China.
- Reform Clinical Trial Management System
Pursuant to the 2018 Draft Amendment, “medical device clinical evaluation” refers to a process where an applicant, through clinical literature, clinical experience and data, clinical trials, etc., verifies whether a medical device satisfies the relevant clinical uses and requirements. The 2018 Draft Amendment clarifies that for the filing of all Category I medical devices, no clinical evaluations are required; for registration of Category II medical devices, in principle, no clinical evaluations are required; and for registration of Category III medical devices, clinical evaluations are required unless the devices have a proven record of safety. For the purpose of making clinical evaluations, subject to any implementing rules to be promulgated along with or after the promulgation of the 2018 Draft Amendment, it is understood that the 2018 Draft Amendment indicates that foreign clinical study data may be accepted and recognized, except for evaluations of those devices that involve very high risks or are used to support or maintain life.3* This would be one of the most noteworthy changes brought by the 2018 Draft Amendment and would save considerable time for imported medical devices (with low or moderate risks) to enter into Chinese market.
- Changes to Post-Marketing Regulatory Requirements
Major changes in post-marketing regulatory requirements include:
-Distributors of Category II medical devices may be exempt from making filings with the regulatory authority if the safety and the effectiveness of the devices can be ensured through the regular supervision of the authority.
– Importation and distribution of used medical devices are explicitly prohibited.
– Pre-approval of medical device commercials is no longer required. Market supervision departments are responsible for monitoring, inspecting and investigating medical device commercials.
– Personal liabilities (including monetary fines and banning the entry into the medical device industry) may be imposed on the legal representative, the quality manager and the person in charge of a MAH, a manufacturer or a distributor in case of serious noncompliance.
It is expected that the 2018 Draft Amendment will be promulgated later this year. We will continue to closely monitor any new developments on this and provide update.
- *Referring to the Regulations on the Supervision and Administration of Medical Device amended and taking effect as of May 4, 2017.
- *Combined with the other governmental authorities into the State Market Regulatory Administration as of March 17, 2018.
- *Chinese local clinical trials are required for evaluations of high-risk medical devices pursuant to the 2018 Draft Amendment.