Chinese Regulatory Bodies Provide Updates on Revised Medical Device Regulations

We reported in March about China’s revised Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739), which introduced changes to the previous Order No. 650 and took effect on June 1. Since the announcement of the regulatory change, the National Medical Products Administration (NMPA) and Center for Medical Device Evaluation (CMDE) have issued additional announcements and documents supporting its implementation.

NMPA publishes announcements on Order No. 739 background and goals

The NMPA issued the following announcements in the spring to elaborate on the background of Order No. 739:

• Encouraging Medical Device Innovation
• Establishing a Medical Device Registrant System
• Improving the Regulatory System, Enhancing the Effectiveness of Supervision, and Pushing the Scientific Supervision of Medical Devices to a New Level
• Intensifying Punishment and Increasing the Cost of Violations

These announcements provide further details on the four main points of the revised regulations, as outlined in a Q&A publication: (1) implementation of reforms affecting the medical device review and approval system; (2) optimization of filing procedures, prioritization of innovative medical devices, and reduction of the burden on corporations; (3) strengthening of the lifecycle processes for medical devices, improving regulatory efficiency; and (4) increase of penalties and costs for violations.

NMPA gives details on Order No. 739 implementation and immediate impact on companies

At the end of May, the NMPA issued an announcement containing details on the implementation of Order No. 739, as development and revision of supporting regulations and guidelines is currently underway.

Beginning on June 1, 2021, establishments with existing medical device registrations or Class I filings must fulfill the registrant or filer obligations according to Order No. 739. However, before the supporting regulations are issued and implemented, applications for registration or filing must continue to be submitted according to the current regulations. One exception is the clinical evaluation requirements, which will be in accordance with Order No. 739, as outlined in Article 3 of the announcement. However, the current list of medical devices exempt from clinical trials will continue to apply until relevant documents are released and implemented under Order No. 739.

​Further details on registrant and filer obligations and information on penalties are provided in the announcement.

CMDE publishes draft requirements, guidelines, and exemptions in support of Order No. 739

​​Additionally, the Center for Medical Device Evaluation (CMDE) published draft documents consisting of requirements, guidelines, and a list of exemptions in support of the implementation of Order No. 739 The list of these drafts is as follows:

• Medical Device Registration Application Data Requirements and Approval Document Format (Revised)
• In Vitro Diagnostic Reagent Registration Application Data Requirements and Approval Document Format (Revised) 
• Classification Rules for In Vitro Diagnostic Reagents
• Technical Guidelines for the Clinical Evaluation of Medical Devices
• Guidelines for Clinical Trials of In Vitro Diagnostic Reagents
• Technical Guidelines for Demonstration of Equivalence of Medical Devices
• Technical Guidelines for Deciding Whether to Conduct Clinical Trials of Medical Devices
• Technical Guidelines for Clinical Evaluation Report for Medical Device Registration
• Technical Guidelines for Methodological Comparison of In Vitro Diagnostic Reagents Exempt From Clinical Trials
• ​List of Medical Devices Exempt From Clinical Evaluation

These drafts may be found as attachments at the bottom of the three announcements linked in the list.

Further resources on Chinese medical device regulation from Emergo by UL:

• China NMPA medical device registration and approval consulting
• Medical device clinical and testing requirements assessment for China