Text Interpretation: Measures for the Supervision and Administration of Domestic Agents of Imported Medical Devices in Beijing (Trial)

Ⅰ. What is the background for the formulation of the “Beijing Municipal Measures for the Supervision and Administration of Domestic Agents of Imported Medical Devices (Trial)”?

To further implement the “Regulations on the Supervision and Administration of Medical Devices”, strengthen the supervision and administration of domestic agents for imported medical devices (hereinafter referred to as agents), and standardize the agency behaviors of agents, the Beijing Municipal Drug Administration has revised the “Beijing Regulations on the Administration of Domestic Agents for Imported Medical Devices (Trial)” and formulated the “Measures for the Supervision and Administration of Domestic Agents for Imported Medical Devices in Beijing (Trial)” (hereinafter referred to as the “Measures (Trial)”).

II. What is the basis for formulating the “Measures (Trial)”?

Article 21 of the 2021 revised “Regulations on the Supervision and Administration of Medical Devices” clearly states that the agent shall assist overseas medical device registrants and filers in fulfilling their relevant legal obligations. This “Measures (Trial)” has been revised in accordance with the requirements of laws and regulations such as the “Regulations on the Supervision and Administration of Medical Devices”, the “Measures for the Administration of Registration and Filing of Medical Devices”, the “Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents”, the “Measures for the Supervision and Administration of Medical Device Production”, the “Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices”, and the “Measures for the Administration of Medical Device Recalls”.

III. What are the regulatory objects and scope of application of the “Measures (Trial)”?

The agent referred to in the “Measures (Trial)” means a domestic enterprise legal person in China designated by an overseas medical device registrant or filer that exports medical devices to China to assist it in fulfilling its legal obligations.

Activities involving acting as an agent for imported medical devices and their supervision and administration within the administrative region of Beijing shall comply with these Measures.

IV. What are the main contents of the “Measures (Trial)”?

includes 4 chapters and 28 articles in total, covering General Provisions, Management of Agents, Supervision and Administration, and Supplementary Provisions. Second, it clarifies the conditions that agents should meet when engaging in agency activities, the obligations they should fulfill, and so on. Third, strengthen the information-based construction of agent supervision, improve the information management of agents in the city, and enhance the level of intelligent supervision work. Fourth, enrich supervision and management methods, and clarify regulatory measures such as risk consultation, credit files, and responsibility interviews.

V. What regulatory responsibilities of relevant departments have been clarified by the “Measures (Trial)”?

The “Measures (Trial)” clearly define the responsibilities of the Municipal Drug Administration, all branches of the Municipal Drug Administration, market supervision and management departments in all districts, as well as the relevant directly affiliated institutions of the Municipal Drug Administration. The Beijing Municipal Drug Administration is responsible for supervising and managing the agency activities of all agents in the city. Beijing Municipal Center for ADR Monitoring is responsible for technical work related to the monitoring of The market supervision and administration departments in various districts are responsible for the supervision and administration of agents engaged in medical device business activities.

Ⅵ. What provisions are there in the “Measures (Trial)” regarding the assistance obligations that should be fulfilled when engaging in the agency activities of imported medical devices?

Article 7 of the “Measures (Trial)” stipulates, in accordance with Article 20 of the Regulations on the Supervision and Administration of Medical Devices, the assistance obligations that shall be performed in engaging in import medical device agency activities as follows: assist overseas medical device registrants and filers in establishing a quality management system suitable for their products and maintaining its effective operation; assist overseas medical device registrants and filers in formulating post-marketing research and risk control plans and ensuring their effective implementation; assist overseas medical device registrants and filers in conducting adverse event monitoring and re-evaluation in accordance with the law; assist overseas medical device registrants and filers in establishing and implementing product traceability and recall systems. Item 7 (5) stipulates the content of “other obligations stipulated by laws, regulations, rules, and the national medical products regulatory authority under the State Council”, and clearly states that in accordance with currently effective rules such as the Measures for the Administration of Monitoring and Re-evaluation of Medical Device Adverse Events and the Measures for the Administration of Medical Device Recalls, in addition to assisting obligations, agents shall also bear primary obligations such as adverse event monitoring and product recall.

VII. What are the provisions in the “Measures (Trial)” regarding how agents and overseas medical device registrants and filers clarify their respective rights and obligations, as well as the reporting of information?

The “Measures (Trial)” clearly states that agents and overseas medical device registrants and filers shall clarify their respective rights, obligations, and responsibilities through means such as entrustment authorization or signing agreements. If there is a change in the authorization or agreement entrusted by the agent to the overseas medical device registrant or filer, making it impossible to continue performing the corresponding obligations, the agent shall, within 5 working days from the date of the change, inform the local municipal drug regulatory bureau branch in writing, and assist the overseas medical device registrant or filer in applying for the corresponding product change filing to the original registration and filing authority within 30 working days. From the date of completion of the change filing, the changed agent shall perform the corresponding obligations.

VIII. What regulatory measures are specified in the “Measures for the Supervision and Administration of Domestic Agents of Imported Medical Devices in Beijing (Trial)”?

The “Measures (Trial)” regulate the requirements for regulatory authorities to improve agent information management and the formulation and implementation of annual inspection plans; clarify the requirements for investigating and handling clues of quality issues, sampling inspections, product recalls, and illegal and irregular behaviors; enrich supervision and management methods, and specify regulatory measures such as risk consultation, credit files, responsibility interviews, and disposal of the list of abnormal operations.

IX. What is the trial period of the “Measures for the Supervision and Administration of Domestic Agents of Imported Medical Devices in Beijing (Trial)”?

These “Measures (Trial)” shall come into force on January 1, 2026, with a trial period of 3 years.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：Beijing Municipal Drug Administration

Translated & edited：Bradyknown