China: Updates on Revised Medical Device Regulations

In March 2021, China has announced revision of Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739, taking effect starting from 1 June 2021. The National Medical Products Administration (NMPA) and the Center for Medical Device Evaluation (CMDE) have published additional statements and documentation supporting the regulation change since it was announced.

Announcement on the background and objectives of Order 739 by NMPA

The NMPA delivered the following announcement in the spring, detailing the background of Order 739:

· Encourage medical device innovation to promote high-quality industrial development

· Establishing a medical device registrant system to further strengthen corporate responsibility

· Improving the regulatory system, enhancing the effectiveness of the regulatory system, and pushing the

scientific regulatory level of medical devices to a new level

· Intensify punishment and increase the cost of violations to protect the high-quality development of the medical device industry

These announcements provide more detailed information on the four main points of the revised regulations:

· Execution of changes influencing the medical device review and approval system

· Optimize archiving procedures, prioritize innovative medical devices and reduce the burden on the company

· Strengthen the life cycle process of medical devices and improve the efficiency of supervision

· Increase penalties and costs for violations

NMPA provides detailed information on the implementation of Order 739 and its direct impact on companies

In late May, the NMPA has make an announcement detailing the implementation of Order No. 739, as the development and revision of relevant regulations and guidelines is in progress.

Sources:

Encourage medical device innovation to promote high-quality industrial development

Establishing a medical device registrant system to further strengthen corporate responsibility

Improving the regulatory system, enhancing the effectiveness of the regulatory system, and pushing the scientific regulatory level of medical devices to a new level

Intensify punishment and increase the cost of violations to protect the high-quality development of the medical device industry

Medical Device Registration Application Document Requirements and Approval Document Format (Revised Draft for Solicitation of Comments)

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