Life Sciences & Health Care Bulletin（No. 1）

You will find under this bulletin
Release of the Medical Device Standards Administrative Measures
Formation of Food Safety Tracing Systems
Release of the Medical Device Standards Administrative Measures
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.
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.
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.
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.
Formation of Food Safety Tracing Systems
On March 28, 2017, the China Food and Drug Administration (the "CFDA") released the Several Provisions in Respect of the Establishment of Food Safety Tracing Systems by Food Production and Operation Enterprises (the "Provisions").
Background
On April 24, 2015, the circulation of the Food Safety Law of the People's Republic of China marked the official establishment of food safety tracing systems in China. Subsequently, the State Council and the CFDA successively issued the Opinion on Accelerating the Construction of Important Product Tracing Systems ([2015] No. 95 Document issued by the General Office of the State Council) and the Opinion on Promoting the Improvement of Food Tracing Systems by Food and Drug Manufacturers and Operators ([2016] No. 122 Document issued by the CFDA), putting forward the general guidance on the implementation of food safety tracing systems.
Overview
1. Scope of application
The Provisions apply to food (exclusive of special food1) production and operation enterprises, with the latter including food (inclusive of edible agricultural products) sales, transportation, storage enterprises and catering enterprises. It is further clarified under the Provisions that homemade products sold by food sales (including edible agricultural products) enterprises and the non-prepackaged food sold by catering enterprises shall be excluded although such food production or operation entities may adopt a food tracing system by reference to the Provisions.
2. Tracing information content
The Provision stipulates in detail the specific scopes of the information required to be recorded by food production and operation enterprises for each process during the entire course of food production and circulation (inclusive of production, sales, catering, transportation, storage and transfer, and so on), establishing a systematic standard for food production or operation enterprises to trace and record information. Taking the process for food production as an example, under the Provisions, a production enterprise shall record information on, among other areas, products, raw and auxiliary materials, production, sales, equipment, facility, personnel, recall, destruction and complaints.
3. Requirements for information recording, preservation and connection
In order to ensure the effective operation of tracing systems, the Provisions provides detailed requirements for information recording, preservation and connection, among which include that a food production or operation enterprise shall take actions such as preserving original records and requiring that all records be jointly signed by the personnel who record the information and who are responsible for reviewing the information so as to ensure that the information recorded is true and valid; and the retention period for records and vouchers shall not be less than six months after the expiration of the shelf life of products; or shall not be less than two years for products without a clear shelf life.
4. General principles and objectives for pilots
The Provisions point out that the food and drug regulatory departments at the provincial level shall, by taking into account multiple factors, including the characteristics for the production and operation of food in different categories, the actual business and operation situation of the specific enterprises, and the cost of such tracing systems for manufacturers and operators, carry out pilots in selected representative enterprises of one or several certain types of food (especially high-risk food) and make progress in a steady manner, with the aim of the basic realization of the traceability of food safety of rice, wheat flour, infant formula milk powder, edible vegetable oil, liquor and other food in key areas as early as practical.
Implications
The Provisions are the first systematic guidance in respect of the establishment of tracing systems by food production and operation enterprises, setting out clear requirements of the tracing systems for the food production or operation enterprises to follow. It is worth paying close attention to how the local Food and Drug Administration will conduct pilots in practice accordingly.
1、Pursuant to the Food Safety Law, special food includes health food, formula food for special medical purposes, and formula food for infants.