In 2000, China’s State Council formulated the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations), and with the rapid development of the medical device industry and the maturity of products, the original regulations have been difficult to adapt to the needs of the new situation. Hence, in 2014 and 2017 respectively, some regulations have been comprehensively revised, while others were partially revised.

However, in accordance with the government's reform of medical device review and approval system, and to encourage innovation and development in the industry to better meet a series of reform initiatives, in December 2020, the 119th Executive Meeting of the State Council formally adopted the new Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739) and announced that the Regulations will come into effect in 2021.6.1.


Throughout the new regulations, there are several main innovations:

(1)     The Regulations elaborate on the violations of the law situation, increase in penalties for violations of laws and regulations, and implementing of these penalties to those applicable.

(2)     Establishment of the management system for the applicants, the rights, and obligations of the registrant in accordance with the law run through the whole life cycle of medical device development, production, operation, and use.

(3)     Improvement of the regulatory system to improve regulatory effectiveness, add unique device identification (UDI) labels for product traceability, and build a medical device safety traceability network.

(4)     Further promotion of the medical device innovations at the institutional level and promote the development of a high-quality industry.


In order to implement the new Regulations better and to ease the obligations required of the manufacturers, NMPA has issued a series of supporting regulations and notices, ranging from the registration management methods, testing, clinical evaluation, declaration of materials, business management, production supervision and other aspects of adjustment. They are discussed in detail, as follows:


1. Measures for the Administration Registration of Medical Devices

Revision to the Measures for the Administration of Medical Device Registration has been drafted and opinions are solicited from the public. Compared with the original Measures, the main changes and additions in the new Measures are in the following sections:

1.1    Revisions:

1.1.1 Requirements of testing reports for Class II and Class III medical devices;

1.1.2 Requirements of overseas  product registration certificate for the innovative medical device;

1.1.3 Requirements of clinical evaluation and clinical trials;

1.1.4 Requirements of conditional approval; 

1.1.5 Requirements of change application

1.2    New items:

1.2.1 Requirements for the summary of instruction for use;

1.2.2 Addition requirements for clinical trial management.


2. Self-testing of Medical Device for Registration

NMPA has issued the “Regulations on Self-testing of Medical Device for Registration (Draft)” on June 2, 2021, directing manufacturers on how to self-testing and submit the testing report. Decree 739 Regulation on Supervision and Management of Medical Devices, announced on March 18, 2021, allows self-testing reports to replace the report issued by accredited testing centers. It says that “testing report can be the self-testing report of the medical device registration by applicant or filing person or the testing report issued by a qualified medical device testing agency”. In the Decree 680 issued in 2017, only Class I devices can utilize self-testing reports.


3. Clinical evaluations

New regulations state that the clinical evaluation of a medical device may be exempted if it meets one of the following conditions:

3.1    The working mechanism is clear, the design is stereotyped, the production process is mature, the clinical application of the same variety of medical devices has been listed for many years and there is no record of serious adverse events, and no changes are made to the general use;

3.2    Other medical devices can be proved safe and effective through non-clinical evaluation.

When conducting a clinical evaluation, clinical trials of medical devices shall be conducted if there is insufficient clinical literature and clinical data to confirm the safety and effectiveness of the product.


4. Device Master File

The NMPA has published Announcement No. 36 of 2021, which outlines the requirements for the voluntary record filing of a Device Master File (DMF) for domestic Class III and imported Class II and III medical devices (including IVD reagents). The contents of this announcement became effective immediately upon publication. The NMPA initially released a draft guidance document concerning DMF record filing in early 2019.

The DMF record filing procedure mainly concerns raw material supplier documentation and is intended to avoid the repeated submission and review of this technical data. The announcement describes the basic procedure and requirements for a DMF submission. The Center for Medical Device Evaluation (CMDE) will issue a DMF registration number following the submission process.


5. Supervision and Administration of Medical Device Operations

In the new Measures for the Supervision and Administration of Medical Device Operations (Revised Draft for Comments), the contents revised are as following:

5.1    Implementation of a management system of the applicants for the medical device record filing and registration, and strengthen their responsibility for quality and safety throughout medical devices’ life cycle;

5.2    Implementation of requirements and simplification of licensing materials and procedures;

5.3    Clear supervision and inspection authority and strengthening of regulatory measures;

5.4    Increase in regulatory measures to address the lack of regulatory tools


6. Production supervision

In the new Measures for the Supervision and Administration of Medical Device Operations (Revised Draft for Comments), the contents revised are as following:

6.1    Implementation of the medical device registrant system;

6.2    Clarification of the regulatory power of the production link and cross-provincial supervision;

6.3    Implementation of hierarchical management according to the risk level;

6.4    Optimization of the process of handling matters related to the production of medical devices;

6.5    Implementation of the production reporting system and implement the responsibility of the main entity;

6.6    Strengthening of the supervision and management of information platform data sharing.


7. Business filing

New regulations state that, in accordance with the provisions of the drug regulatory department under the State Council, Class II medical devices whereby their safety and effectiveness are not affected by the circulation process, may be exempted from business filing.


Qualtech will keep you updated in the coming months as the above drafts are finalized and more information is sourced from the Authority. In the meantime, make sure to check if the above changes affect any of your medical devices currently in the China medical device market. Qualtech has had vast experience in the China medical device market for the past decade, and we can guide you in the process of getting your medical devices effectively sold in the China market. If you need further consultation, feel free to get in touch with us at any time.




Regulations on the Supervision and Administration of Medical Devices (Decree No. 739 of the State Council)

Measures for the Administration of Medical Device Registration (Revised Draft for Comments)

Measures for the Administration of In vitro Diagnostic Reagents Registration (Revised Draft for Comments)

Regulations on self-testing of medical device registration (Revised Draft for Comments)

Technical Guidelines for Clinical Evaluation of Medical Devices (Draft for Comments)

Code of Quality Management for Clinical Trials of Medical Devices (Revised Draft for Comments)

Model Medical Device Clinical Trial Program

Medical device registration declaration information requirements and approval supporting document format (revised draft for comments)

Measures for the Supervision and Administration of Medical Device Operations (Revised Draft for Comments)

Measures for the Supervision and Administration of Medical Device Production (Revised Draft for Comments)

Rules for the Classification of In vitro Diagnostic Reagents (Draft for Comments)

List of Class II Medical Device Products Exempt from Business Filing (Draft for Comments)