Provisions for Medical Device Standards

(Decree No. 33 of China Food and Drug Administration)

Issued on April 26, 2017

The Provisions for Medical Device Standards adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, is hereby promulgated and shall be effective as of July 1, 2017.

Minister: Bi Jingquan

April 17, 2017

Provisions for Medical Device Standards

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the Standardization Law of the People's Republic of China, the Regulations for the Implementation of the Standardization Law of the People's Republic of China and the Regulations for the Supervision and Administration of Medical Devices as well as other laws and regulations to promote progress in science and technology, ensure the safety and effectiveness of medical devices, improve health care and enhance medical device standards administration.

Article 2 Medical device standards stated in these Provisions refer to the unified technical requirements for the research and development, manufacturing, distribution, use, supervision and administration of medical devices which are formulated and revised by China Food and Drug Administration as per its duties and issued in accordance with the legal procedures so as.

Article 3 The formulation and revision, implementation, supervision and administration of medical device standards within the territory of the People’s Republic of China shall conform to laws, administrative regulations and these Provisions.

Article 4 Medical device standards are classified into mandatory standards and recommended standards by their legal effects.

Technical requirements that ensure human health and safety shall be formulated as mandatory national standards and mandatory industry standards for medical devices.

Technical requirements that satisfy basic general use, support mandatory standards, and play a role of leading medical device industries shall be formulated as recommended national standards and recommended industry standards for medical devices.

Article 5 Medical device standards are classified into basic standards, method standards, management standards and product standards according to the subjects of regulation.

Article 6 China Food and Drug Administration shall develop the medical device standards plan, establish the working mechanism for medical device standards administration and improve the medical device standards administration system in accordance with laws.

Article 7 Enterprises, social organizations, education and research institutions and individuals are encouraged to participate in the formulation and revision of medical device standards and supervise their implementation.

Article 8 Participation in international standardization activities and formulation of international medical device standards as well as adoption of such standards are encouraged.

Article 9 China Food and Drug Administration shall, in accordance with relevant national regulations, give commendation and awards to organizations and individuals who have made outstanding achievements in the field of medical device standards.

Chapter II Standards Administration Responsibilities

Article 10 China Food and Drug Administration shall perform the following responsibilities:

(1) Organize the implementation of laws and regulations related to medical device standards administration and develop the working mechanism for medical device standards administration;

(2) Organize the development of medical device standards plan and compile the annual working plans for standards formulation and revision;

(3) Organize the formulation and revision of medical device standards pursuant to the law, and issue the industry standards for medical devices;

(4) Guide and supervise medical device standards administration pursuant to law.

Article 11 The Center for Medical Device Standardization Administration of China Food and Drug Administration (hereinafter referred to as "Center for Medical Device Standardization Administration") shall perform the following responsibilities:

(1) Organize research on medical device standards system, draft the medical device standards plan and proposals on the annual working plans for standards formulation and revision;

(2) Undertake administration of the formulation and revision of medical device standards pursuant to law;

(3) Undertake administration of the technical committees on medical device standardization pursuant to law;

(4) Undertake organization of the publicity and training of medical device standards;

(5) Organize survey of standards implementation and coordinate efforts to solve major technical issues during standards implementation;

(6) Undertake work relevant to medical device international standardization activities and foreign exchanges and cooperation;

(7) Undertake informatization of medical device standards and organize the publication of medical device industry standards.

(8) Undertake other standards administration work assigned by China Food and Drug Administration.

Article 12 China Food and Drug Administration shall, based on the demands of medical device standardization, establish technical committees on medical device standardization upon approval in accordance with laws.

The technical committees on medical device standardization shall perform the following responsibilities:

(1) Carry out research on medical device standards and put forward proposals on the standards development plan and standards system in each specialized field;

(2) Undertake the drafting, public consultation, technical review of medical device standards and other organizational work in each specialized field and be responsible for the technical contents and quality of the standards;

(3) Undertake technical guidance of medical device standards in each specialized field and assist in solving technical problems during the implementation of standards;

(4) Be responsible for collecting and sorting documents for medical device standards in each specialized field and establish technical archives;

(5) Be responsible for the follow-up assessment of the implementation of medical device standards in each specialized field;

(6) Be responsible for the consultation and explanation on technical contents of the medical device standards in each specialized field;

(7) Undertake the publicity, training, academic exchange of medical device standards in each specialized field and relevant international standardization activities.

Article 13 China Food and Drug Administration may, based on regulatory needs, determine the technical units charged with medical device standardization in specialized technical fields which are not covered by the current technical committees on medical device standardization following relevant procedures. The technical units shall carry out tasks for medical device standardization in the corresponding fields by referring to the responsibilities of the technical committees on medical device standardization and relevant regulations.

Article 14 Local food and drug regulatory departments shall perform the following responsibilities in their administrative areas in accordance with laws:

(1) Organize the implementation of laws and regulations of medical device standards administration;

(2) Organize and participate in work relevant to the formulation and revision of medical device standards;

(3) Supervise the implementation of medical device standards;

(4) Gather information on problems arising during implementation of the standards and report such information to food and drug regulatory departments of a higher level.

Article 15 Medical device development institutions, manufacturers, distributors and user facilities shall strictly implement the mandatory standards for medical devices.

Medical device development institutions, manufacturers, distributors and user facilities are encouraged to actively develop and adopt the recommended standards for medical devices, actively participate in the formulation and revision of medical device standards, and provide feedback on the problems during the implementation of medical device standards to relevant departments in a timely manner and put forward improvement suggestions.

Chapter III Standards Formulation and Revision

Article 16 Procedures for the formulation and revision of medical device standards include standards project initiation, drafting, public consultation, technical review, approval and issuance, reexamination and abolishment, etc. The specific stipulations shall be formulated by China Food and Drug Administration.

Where the formulation and revision of standards for the medical device supervision is in urgent need, it may be conducted in accordance with the expedited procedures specified by China Food and Drug Administration.

Article 17 The Center for Medical Device Standardization Administration shall solicit project initiation proposals for the formulation and revision of medical device standards openly in accordance with the medical device standards plan.

The corresponding technical committee on medical device standardization (including the technical unit charged with standardization, the same below) shall put forward the project initiation application for the standards plan project in its specialized field after studying the initiation proposals collected.

Where the initiation proposal for the standards plan project involves two or more technical committees on medical device standardization, the Center for Medical Device Standardization Administration shall be responsible for coordinating and determining the leading technical committee which shall put forward the project initiation application for the standards plan project.

Article 18 After public consultation and organizing expert review on the initiation application for medical device standards plan project, the Center for Medical Device Standardization Administration shall propose the medical device standards plan project and the suggestions on the annual working plan for standards formulation and revision, and submit them to China Food and Drug Administration for review.

The medical device standards plan projects that are approved by China Food and Drug Administration shall be released to the public. The national standards plan project shall be submitted to the competent standardization administrative department under the State Council for approval and assignment; the industry standards plan project shall be approved and assigned by China Food and Drug Administration.

Article 19 Medical device manufacturers, distributors, user facilities, regulatory departments, testing agencies, relevant education and research institutions and social groups may submit applications for drafting relevant medical device standards to the technical committee on medical device standardization that undertakes the medical device standards plan projects. The technical committee on medical device standardization shall, in consideration of the technical contents of the standards, select the drafting unit based on the principles of openness, fairness and emphasis on merit.

The drafting unit shall draft the medical device standard on the basis of full verification of the technical contents after conducting extensive surveys, in-depth analysis and research, and drawing experience from relevant international standards. The drafting unit shall then submit the draft for comment to the Center for Medical Device Standardization Administration after preliminary review by the technical committee on medical device standardization.

Article 20 The medical device draft standard for comment shall be open to public consultation on the website of the Center for Medical Device Standardization Administration, lasting for a period of two months in general. The technical committee on medical device standardization that undertakes the medical device standards plan project shall summarize the comments received and give feedback to the drafting unit. The drafting unit shall carefully study the summarized suggestions, and modify the draft for comment to form the proposed draft.

Article 21 The technical committee on medical device standardization that undertakes the medical device standards plan project shall be responsible for organizing the technical review of the proposed draft of the medical device standard. After the proposed draft passes the technical review, the draft for approval, implementation suggestions and relevant materials for medical device standards shall be submitted to the Center for Medical Device Standardization Administration for examination.

Article 22 The Center for Medical Device Standardization Administration shall submit the reviewed medical device standards draft for approval and review conclusions to China Food and Drug Administration for examination. Medical device national standards passing the examination shall be submitted to the competent standardization administrative department under the State Council for approval and issuance; for medical device industry standards passing the examination, China Food and Drug Administration shall determine and announce the date and requirements for their implementation.

Medical device national standards and industry standards shall be disclosed in accordance with the relevant regulations of the competent standardization administrative department under the State Council for public reference.

Article 23 Where modification is needed because certain technical content affects application of the standard or the original standard needs minor addition or deletion after the medical device standard has been approved and issued, a standards amendment form shall be used. The standards amendment form shall be prepared in accordance with the procedures for standards formulation and revision, and reviewed and issued by the original approval department for the medical device standard.

Article 24 The technical committees on medical device standardization shall reexamine medical device standards that have been issued and implemented. The committees shall organize timely reexamination of the effectiveness, applicability and advancement of medical device standards in keeping with scientific progress, industry development and regulatory demands and put forward the reexamination conclusion. The reexamination conclusion include “Remain in force", "To be revised" and "Abolished". The reexamination cycle shall not exceed five years in principle.

The reexamination conclusion for medical device standards shall be submitted to China Food and Drug Administration for approval after passing the review of the Center for Medical Device Standardization Administration. The reexamination conclusion for medical device national standards shall be submitted to the competent standardization administrative department under the State Council for approval; the reexamination conclusion for medical device industry standards shall be submitted to China Food and Drug Administration for review and approval, and standards for which the reexamination conclusion is "Abolished" shall be announced by China Food and Drug Administration.

Chapter IV Standards Implementation and Supervision

Article 25 Medical device manufacturers shall organize the manufacturing in strict accordance with the registered or filed product technical requirements and ensure that the delivered medical devices meet the mandatory standards as well as the registered and filed product technical requirements.

Article 26 Contents of the recommended standards that are referred to in laws and regulations, normative documents and registered or filed product technical requirements shall be implemented compulsively.

Article 27 The product technical requirements of medical devices shall fit the design characteristics, intended use and quality control levels of the products and shall not be lower than the mandatory national standards and mandatory industry standards applicable to the products.

Article 28 The food and drug regulatory departments shall supervise and inspect the implementation of medical device mandatory standards and the registered or filed product technical requirements by medical device enterprises.

Article 29 Any unit or individual have the right to report to the food and drug regulatory departments misbehaviors that violate the medical device mandatory standards and registered or filed product technical requirements. Departments receiving such reports shall take proper actions in accordance with regulations in a timely manner.

Article 30 Information management shall be carried out for medical device standards. The project initiation, issuance and implementation of medical device standards shall be made public in a timely manner.

Article 31 The food and drug regulatory departments shall organize and guide the publicity and training of medical device standards after their issuance.

Article 32 The technical committees on medical device standardization shall conduct follow-up assessment on standards implementation. The Center for Medical Device Standardization Administration shall make statistical analysis on the implementation of mandatory standards based on the follow-up assessment.

Chapter V Supplementary Provisions

Article 33 The serial number for medical device national standards shall be made in accordance with regulations of the competent standardization administrative department under the State Council. The code for medical device industry standards is composed of capitalized Chinese phonetic alphabets. The code for mandatory industry standards is "YY" , and that for recommended industry standards is "YY/T".

The serial number for industry standards is composed of the code, standard number and the year of issuance of the industry standard. The format is: YY　××××1-××××2 and YY/T　××××1-××××2.

××××1 is the standard number and ××××2 is the year of issuance.

Article 34 Social groups established pursuant to laws may formulate and issue group standards. The administration of group standards shall conform to relevant national regulations.

Article 35 The medical device reference sample is the material standards used in the inspection and testing of medical devices, and its administration shall conform to relevant national regulations.

Article 36 These Provisions shall be effective as of July 1, 2017. The Provisions for Medical Device Standards (Trial) promulgated on January 4, 2002 (Decree No. 31 of Former State Drug Administration) is annulled simultaneously.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.