国家食药监管总局就修订《医疗器械标准管理办法》公开征求意见(10/24/2014)

On Oct. 24, 2014, the China Food and Drug Administration (the CFDA) released for public comments the proposed draft of the revised Measures on the Administration of the Standards of Medical Devices (Draft for Comment) (the Draft). The public comment period ended Nov. 15, 2014.

Compared with the last version of the Measures on the Administration of the Standards of Medical Devices promulgated in 2002 (the 2002 Measures), the Draft proposes the following significant changes:

Classification of the Standards of Medical Devices

Under the 2002 Measures, there are three standards of medical devices – national standards, industry standards and standards of registered devices. Standards of registered devices refer to those standards created by the manufacturers and verified by the competent food and drug authorities. The Draft proposes to abolish the standards of registered devices and to divide national standards and industry standards into mandatory standards and recommended standards according to their natures.

Note that under the Regulations on the Supervision and Administration over Medical Devices (the Regulations), which became effective June 1, 2014, medical devices should comply with mandatory national standards or, in the absence of mandatory national standards, mandatory industry standards. The revisions proposed by the Draft are consistent with the above provision of the Regulations.

Role of Medical Device Standardization Administration Center

The Draft provides that a Management Institution of Medical Device Standardization established and entrusted by the CFDA (i.e., the Medical Device Standardization Administration Center established in 2010) should be the authority in charge of: (i) providing supporting work for the standardization of medical devices; (ii) organizing and coordinating the formulation and revision of medical device standards; (iii) organizing the research efforts for the standards system of medical devices and proposing plans and policies for the standardization of medical device; (v) providing guidance to the Medical Devices Standardization Technical Committee; and (iv) other administration matters concerning medical device standards.

The Medical Device Standardization Administration Center is currently managing 22 Medical Devices Standardization Technical Committees, which cover different areas of medical devices and are responsible for formulating and revising of the standards of different medical devices.

Procedures regarding Formulation and Revision of Medical Device Standards

The Draft also proposes detailed procedures concerning the formulation and revision of medical device standards, including the following stages: initiation, drafting, solicitation of public comments, review, approval for release and re-examination.  According to the Draft, any organization or individual  can propose to initiate a standard for medical devices through the corresponding Medical Devices Standardization Technical Committee.

  • Measures on the Administration of the Standards of Medical Devices (Draft for Comment)
  • -《医疗器械标准管理办法(修订草案征询意见稿)》
  • Issuing authority: China Food and Drug Administration
  • Date of issuance: Oct. 24, 2014/Public Comment Deadline: Nov. 15, 2014