医疗器械召回管理办法—英文版

Ministry of Health of People’s Republic of China

Ordinance No.

The Regulation of Medical Devices Recall Administration (Test) was approved by the Conference of Ministry of Health on June 28th 2010, and will be activated on July 1st 2010.

The Regulation of Medical Devices Recall Administration (Test)

Chapter 1

General Guideline

Article 1

For better supervision of Medical Devices, to guarantee people’s health and well-being, according to The Administration of Medical Devices, and State Council: About the Special Rules for the improvement of Food and Food Safety, this legislation is drafted.

Article 2

This regulation applies to Medical Devices sold within PRC.

Article 3

The definition of Medical Devices recall refers to the actions taken to eliminate the defects of the already sold devices, such as warning, checking, re-labeling, fixing, amending, and completing user’s guides, software updating, replacing, recalling, and destroying of a certain line or model.

Article 4

The defects mentioned above refers to the medical devices that may be of unreasonable safety or health hazards to people when operated under normal conditions.

Article 5

The major force of the controlling and eliminating of defective products are the manufacturers of medical devices, therefore these companies are to take full responsibilities for the safety of their products.

Article 6

Under this regulation, the medical devices’ manufacturers are to establish and perfect their recalling system, to collect the related information regarding the safety of their medical devices, and to investigate, estimate their possible defective products, in order to recall these defective medical devices promptly.

Companies that run business with or make use of the medical devices are obliged to assist with the recalling of the medical devices, and informing feedbacks on the recalling information, controlling and reclaiming the defective medical devices strictly according to the recalling regulation.

Article 7

On condition that companies that run business with or make use of the medical devices discover the medical devices they possess are defective items, the usage and marketing of these products are to stop immediately, while they should inform the manufacturing and supplying parties of these certain products, and report to the Food and Drug Administration and Supervision Department where they belong to; the organizations making use of these devices are also to report to the Health Administration of the province, Autonomous Region or Municipality directly under the Central Government.

After receiving the reports from these companies, the Administration Department should notify the Health Administration of the province, Autonomous Region or Municipality directly under the Central Government of the manufacturing company.

Article 8

For the manufacturers that are having their devices called back, the appointed agencies in China of the imported medical devices manufactured over-seas are under the administration of Health Administration of the province, Autonomous Region or Municipality directly under the Central Government, and they are in charge of the reclamation of these devices, and the other provinces and regions equivalent to it should provide with assistance, cooperate this region with the reclamation and the related work.

The SFDA is in charge of the management of recalling of medical devices national-wide.

Article 9