Key Points of the Beijing Municipal Medical Products Administration's Detailed Implementing Rules for the Measures for the Supervision and Administration of Medical Device Distribution in Beijing (Jing Yao Jian Fa [2023] No. 26)

Basic Information on the Document

The Detailed Implementing Rules for the Measures for the Supervision and Administration of Medical Device Distribution in Beijing were issued by the Beijing Municipal Medical Products Administration under Jing Yao Jian Fa [2023] No. 26 on February 1, 2023 (the date the notice was issued), and took effect on March 1, 2023. The 2017 version of the Detailed Implementing Rules was repealed at the same time. The Rules were formulated on the basis of State Administration for Market Regulation Order No. 54, the Measures for the Supervision and Administration of Medical Device Distribution, and are the specific implementing provisions of the national Measures at the Beijing municipal level.

Refined Requirements for Distribution Licensing and Filing

The distribution of Class III medical devices requires obtaining a medical device distribution license, and the district market regulation bureau must make a decision within 20 working days; the distribution of Class II medical devices is subject to a filing system, and the district market regulation bureau must complete an on-site inspection within 3 months. The warehouse area for distributing Class III medical devices must be no less than 40 square meters; where cold-chain products are involved, cold storage facilities of no less than 20 cubic meters must be provided.

Special Requirements for Transportation and Storage Service Enterprises

For enterprises providing third-party transportation and storage services to medical device distribution enterprises, the area of the main warehouse must be no less than 1,500 square meters and that of a branch warehouse no less than 500 square meters, and they must be equipped with modern logistics facilities and a computer information management system.

Routine Supervision Arrangements

The district market regulation bureau must implement classified and tiered management of medical device distribution enterprises within its jurisdiction and formulate an annual supervisory inspection plan. For newly established enterprises, enterprises with risk hazards, or enterprises whose rectification is inadequate, the frequency of unannounced inspections shall be increased. Class III distribution enterprises must submit a quality management self-inspection report before the end of each year.

Source: Beijing Municipal Medical Products Administration, Notice on Issuing the "Detailed Implementing Rules for the Measures for the Supervision and Administration of Medical Device Distribution in Beijing" (Jing Yao Jian Fa [2023] No. 26), https://yjj.beijing.gov.cn/yjj/zwgk20/tz7/326032139/index.html