The new revision of the supervision and management of medical devices regulations provide that the state according to the medical device product category step by step implementation of medical devices

The new revision of the supervision and management of medical devices regulations provide that the state according to the medical device product category step by step implementation of medical devices only Unique labeling system. The new revision of the "Regulations" proposed that the state according to the medical device product categories, step by step implementation of the medical device unique labeling system, to achieve traceability of medical devices.

Legal basis:

"Supervision and Administration of Medical Devices Regulations" Article 35 The medical device registrant, the filing of the person, the commissioned manufacturer shall, in accordance with the quality management standard for the production of medical devices, to establish and improve the production of medical devices and ensure that the quality of management system and to ensure its effective operation; strictly in accordance with the registered or filed by the technical requirements of the product to organize the production to ensure that the medical devices comply with the mandatory standards as well as the registration or filing of the product, to ensure that the medical device is in compliance with the mandatory standards, as well as the registration or filing of the product. Mandatory standards and registered or recorded product technical requirements.

Medical device registrants, filers, commissioned manufacturers should be regularly on the operation of the quality management system for self-examination, and in accordance with the provisions of the State Council drug supervision and management department to submit a self-examination report.