6 June, 2017
On April 26, 2017, the China Food and Drug Administration (“CFDA”) released the Measures on the Administration of Medical Device Standards (Order No. 33 of the CFDA) ( the” Measures”), which applies to the enactment, revision, enforcement, supervision and administration of medical device standards within the territory of the People's Republic of China. The Measures will come into force on July 1, 2017, and the Measures on Administration of Medical Device Standards (for trial implementation) (the former order No. 31 of the CFDA) released on January 4, 2002 shall be abolished simultaneously.
I. Background
On April 1, 2000, the Regulations on the Supervision and Administration of Medical Devices took effect, and as its supporting rules, on January 4, 2002, the CFDA released the Measures on the Administration of Medical Device Standards (for trial implementation) (the “Measures for Trial Implementation”), which specified the national standard, industry standard and registered products standard as a three-level standard system for medical devices.
On March 7, 2014, the State Council revised the Regulations on the Supervision and Administration of Medical Devices; during the same year, on July 30th, the CFDA released the Measures on the Administration of Registration of Medical Devices. These two regulations cancelled the “registered product standards” and defined the “product technical requirements” and its legal position, as such the two-level standard system (i.e., the national standard and industry standard) was formed.
Later, on March 11, 2015, the State Council released the Plan for Deepening the Reform of Standardization Work, requiring consolidation and streamlining of the compulsory standards and improving and optimizing the recommended standards; and then the State Council issued the Opinions on Reform of the Review and Approval System for Drugs and Medical Devices on August 9, 2015, requiring reform of the approval methods for medical devices and to promptly amend the medical device standards.
Under the foregoing background, in order to strengthen the administration of medical device standards, the CFDA organized to revise the Measures for Trial Implementation and the current version of the Measures is therefore formed.
II. Essential Concepts
Definition of medical device standards
According to the Measures, the medical device standards refer to the uniform technical requirements which shall be enacted and revised under the organization of the CFDA, released in accordance with legal procedures, and shall be followed during the course of the research and development, production, operation, use, supervision and administration of medical devices.
Categories of medical device standards
The Measures have deleted all the context regarding registered product standards under the Measures for Trial Implementation, and expressly specified that the medical device standards are categorized into national standards and industry standards.
In addition, according to their enforcement, the medical device standards are categorized into compulsory standards and recommended standards. Specifically,
-with respect to those technical requirements to guarantee the safety of human health and life, the compulsory national standards and compulsory industry standards shall be enacted;
-with respect to those technical requirements to satisfy fundamental and common use, affiliated to the compulsory standards and leading the medical device industry, the recommended national standards and recommended industry standards may be enacted.
Legal position of product technical requirements
Consistent with the Regulation on the Supervision and Administration of Medical Devices and the Measures on the Administration of Registration of Medical Devices released in 2014, the Measures replace the registered product standard with the product technical requirements, and further specify the relationship among the product technical requirements, compulsory standards and recommended standards.
According to the Measures on the Administration of Registration of Medical Devices, an applicant applying for registration or filing of a medical device shall prepare the product technical requirements for the medical device and submit to the food and drug authority for filing or approval. The Measures make further clarifications with respect to the product technical requirements:
- The product technical requirements shall not be lower than the compulsory national standards and compulsory industry standards;
- Medical device enterprises shall strictly obey the registered or filed product technical requirements during manufacturing, and make sure that the medical devices manufactured are in compliance with the compulsory standards and the registered or filed product technical requirements;
- The recommended standards of medical devices shall become mandatory when being cited by the laws, regulations, rules, and registered or filed product technical requirements.
III.Standard Administration Duties and Procedures for Enactment and Revision of Standards
Standards administration duties
The Measures have expressly stated the duties and obligations of the CFDA, the Administration Center for Medical Device Standards, the Standardization Technology Committee for Medical Devices, the entities undertaking the standardization technology related work for medical devices, local Food and Drug Administration, R&D institutes for medical devices, producers, operators and users of medical devices, respectively during the administration of medical device standards.
Procedures of enactment and revisions of the standards
According to the Measures, the procedures for the enactment and revision of medical device standards should consist of project initiation, drafting, release for public comments, technical examination, approval and issuance, revisiting, abolishment, and so on. Amongst those procedures, we summarized the following bullet points which are worth attention:
- Expedited procedures. As to the medical device standards for which there is an urgent need to enact or revise, the enactment or revisions thereof may follow the expedited procedures provided by the CFDA;
- Improvement of public participation. During the phase of project initiation, the contemplated project of medical device standards reviewed and approved by the CFDA shall be released to the public; during the stage of drafting, the producers, operators or users of the medical devices, the administration departments, the examining institutes, the related educational and research institutes, social entities, and so on, may apply to draft the related medical device standards, and the Standardization Technology Committee for Medical Devices will select the best entity to work on the drafting; in addition, the draft version of the medical device standards shall be released for public comments on the website of the Administration Center for Medical Device Standards, generally for two months;
- Approval and issuance. After being examined by the Standardization Technology Committee for Medical Devices, reviewed by the Administration Center for Medical Device Standards, and approved by the CFDA, the national standards will be submitted to the Administration of Standardization of the State Council for final approval and issuance; while the industry standards will be issued by the CFDA. Both the national standards and industry standards shall be open to the public for review. The Standardization Technology Committee for Medical Devices shall revisit the effectiveness, feasibility and advancement of the issued medical device standards based on the progress of scientific technology, industry development, and the need for supervision, and upon revisiting, decide to keep such standards effective, or revise or abolish such standards. In general, the term for the revisit shall be no longer than 5 years.
For further information, please contact:
Yang Fan, Partner, Jun He
yangfan@junhe.com
