Key Points of the Measures for the Supervision and Administration of Medical Device Distribution (State Administration for Market Regulation Order No. 54)

Basic Information on the Document

The Measures for the Supervision and Administration of Medical Device Distribution were promulgated by the State Administration for Market Regulation by Order No. 54 on March 10, 2022, and took effect on May 1, 2022. They apply to all parties engaged in "medical device distribution activities within the territory of the People's Republic of China, and the supervision and administration thereof."

Classified Management System

The Measures establish a three-tier classified management framework: engaging in the distribution of Class III medical devices requires obtaining a distribution license; engaging in the distribution of Class II medical devices requires filing with the drug regulatory department at the level of the districted city where the enterprise is located; and engaging in the distribution of Class I medical devices requires neither a license nor filing. A distribution license is valid for 5 years, and an application for renewal must be submitted within the period from 90 to 30 working days before its expiry.

Distribution Quality Management Requirements

Distribution enterprises must establish and improve a whole-process quality management system covering procurement, acceptance, storage, sale and transportation, and ensure that products are traceable. They must establish an incoming inspection system and a sales record system, and retain documents and records for no less than 2 years after the expiry of the product's shelf life; for products without a shelf life, the retention period is no less than 5 years.

Supervisory Inspection and Legal Liability

Drug regulatory departments carry out classified and tiered supervisory inspections in accordance with the law, and increase the inspection frequency for enterprises with adverse records, newly established enterprises, or enterprises whose conditions have changed. Engaging illegally in the distribution of Class III medical devices (without obtaining a license) may be subject to a fine of up to RMB 200,000.

Source: State Administration for Market Regulation, Measures for the Supervision and Administration of Medical Device Distribution (SAMR Order No. 54), Chinese Government Website, https://www.gov.cn/zhengce/zhengceku/2022-03/23/content_5680762.htm