国家食品药品监管总局发布《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》、《医疗器械说明书和标签管理规定》、《医疗器械生产监督管理办法》及《医疗器 械经营监督管理办法》 (30/07/2014)

On July 30, 2014, the National Food and Drug Administration released newly modified Administrative Measures for the Registration of Medical Devices (the Medical Devices Registration Measures) and four other measures regarding medical devices, including the Administrative Measures for the In Vitro Diagnostics Registration (the IVD Measures), the Administrative Measures for the Instructions and Labels of Medical Devices (the Instructions and Labels Measures), the Measures for the Supervision and Administration of Medical Devices Production (the Medical Devices Production Measures), and the Measures for the Supervision and Administration of Medical Devices Operation (the Medical Devices Operation Measures). Key changes introduced by these measures are summarized below.

Filing and Registration in Accordance with Classifications of Medical Devices

The Medical Devices Registration Measures provide that Class-I Medical Devices should be managed by record-filing, and Class-II and Class-III Medical Devices shall be managed by registration, which is different from the current stipulation that all medical devices should be managed by registration. In accordance with this change, the IVD Measures correspondingly modify the current practice of registration for all IVD devices, a special kind of medical devices, into the record-filing for Class-I IVD devices and registration for Class-II and Class-III IVD devices.

Specified Registration (Filing) Procedures

The Medical Devices Registration Measures provide specific requirements to regulate the  technical review during the registration procedures. The competent Food and Drug Administration (FDA) should forward the application materials to the relevant technical review agency within three working days upon its acceptance of such application. The technical review agency should complete the technical review of an application for the registration of a Class-II or a Class-III medical device within 60 or 90 working days respectively. In addition, during the technical review, if the quality management system verification is considered to be necessary by the FDA, the FDA should finish such verification within 30 working days; however, the time spent on quality management system verification is excluded from the time limitation for the technical review.

Supervision Liability of Medical Devices Production/Operation Enterprises

The Medical Devices Production Measures and Medical Devices Operation Measures both introduce specific chapters to regulate the supervision liability of the medical devices’ production or operation enterprises:

  • The Medical Devices Production Measures provide that the medical devices’ production enterprises should establish a quality management system and keep the effective operations in accordance with relevant administrative rules regarding quality management for production of medical devices.
  • The Medical Devices Operation Measures provide that the medical devices’ operation enterprises should establish an operation management system which covers the quality control of the medical devices in the whole process of operation and keep complete records of related procedures in order to guarantee the operation conditions and actions continuously meet the requirements in accordance with relevant administrative rules regarding quality management for operations of medical devices.

Stricter Rules on Instructions and Labels of Medical Devices

The newly modified Instructions and Labels Measures provide stricter rules on the instructions and labels of medical devices.

  • With respect to the instructions of medical devices, the Instructions and Labels Measures require the instructions to include (i) the name, address, contact information and after-sale service entity of the registrant of the medical devices, (ii) the list of accessories, (iii) the explanation of the diagrams, symbols and abbreviations used in the labels, as well as (iv) the edit date or modification date of the instructions.
  • With respect to the labels of medical devices, the Instructions and Labels Measures require the labels to include (i) special storage and operation conditions and instructions, and (ii) the warning symbols or Chinese warning instructions for medical devices that may cause negative environmental influences or may be radioactive.
  • Administrative Measures for the Registration of Medical Devices
  • 《医疗器械注册管理办法》
  • Issuing authority: China National Food and Drug Administration
  • Date of issuance: July 30, 2014 / Effective date: October 1, 2014
  • Administrative Measures for the In Vitro Diagnostics Registration
  • 《体外诊断试剂注册管理办法》
  • Issuing authority: China National Food and Drug Administration
  • Date of issuance: July 30, 2014 / Effective date: October 1, 2014
  • Administrative Measures for the Instructions and Labels of Medical Devices
  • 《医疗器械说明书和标签管理规定》
  • Issuing authority: China National Food and Drug Administration
  • Date of issuance: July 30, 2014 / Effective date: October 1, 2014
  • Measures for the Supervision and Administration of Medical Device Production
  • 《医疗器械生产监督管理办法》
  • Issuing authority: China National Food and Drug Administration
  • Date of issuance: July 30, 2014 / Effective date: October 1, 2014
  • Measures for the Supervision and Administration of Medical Device Operation
  • 《医疗器械经营监督管理办法》
  • Issuing authority: China National Food and Drug Administration
  • Date of issuance: July 30, 2014 / Effective date: October 1, 2014