National Food and Drug Administration Apparatus [2005] No. 208

The professional standardization technical committees and focal units of various medical devices:

In order to solve the problems of China's medical device industry standards as soon as possible and build a more scientific and reasonable medical device standard system, our bureau has decided to conduct a comprehensive clean-up of the current medical device industry standard items starting from June 2005.

The clean-up work is divided into five stages: standard centralized confirmation, evaluation clean-up, data collection and sorting, online publicity, and announcement of the final clean-up results. The medical equipment department of our bureau will make specific arrangements for each stage of the work. The "Medical Device Industry Standard Project Cleanup Implementation Plan" (attachment) is now printed and distributed to you. Please organize carefully and carry out the cleanup work strictly in accordance with the plan requirements.

Attachment: Implementation plan for cleaning up medical device industry standard projects

State Food and Drug Administration

May 24, 2005

Attachment:

Implementation plan for cleaning up medical device industry standard projects

First, the purpose of cleaning up

With the continuous strengthening of the status and role of medical device standardization in the supervision of medical devices, the society's demand for standards continues to increase, and the standards in the medical device industry standards are obsolete, low-tech, and unreasonable in the system structure. A series of issues have seriously affected the market adaptability of medical device industry standards.

In order to solve the problems in China's medical device industry standards as soon as possible, it is urgent to clean up the current medical device industry standard items and establish a standard system that adapts to the socialist market economic system as soon as possible.

Through this cleanup, the existing medical device industry standards will be revised, integrated or abolished, and the uniformity, coordination, scientific rationality, and advanced applicability of the medical device industry standards will be improved. Provide strong technical support for medical device supervision.

Second, the scope of cleaning

The scope of this clean-up work includes:

As of the end of December 2004, the medical device industry standards that have been approved and issued include published and unpublished standards.

Three, clean up objects

(1) Abolish the industry standards that have not been published and have not been used for a long time;

(2) The abolition or revision has serious problems, the technical content is outdated or the original international standard has been revised;

(3) The standards are too small and too small;

(4) Adjust the compulsory medical device industry standards that should not be compulsory into recommended standards;

Four. Legal basis for cleanup

(1) "The Standardization Law of the People's Republic of China" and related regulations;

(2) "Regulations on the Supervision and Administration of Medical Devices."

5. Technical basis for evaluation and cleanup

For the requirements and standards of this medical device industry standardization project cleanup (hereinafter referred to as “trade standard cleanup”), please refer to the "National Standards and National Standards Revision Project Evaluation Manual".

Six. Cleaned up organizations

The State Food and Drug Administration is responsible for the overall deployment, supervision and commissioning of the preparatory group of the Medical Device Standardization Technical Committee of the State Food and Drug Administration (hereinafter referred to as the preparatory group) to carry out the work, each medical device-specific standardization technical committee or standard The focal unit is specifically responsible for implementation.

Contact information of the preparatory group of the Medical Device Standardization Technical Committee of the State Food and Drug Administration:

Contact person: Chen Yanping, Lan Wengchi

Contact number: 68330525, 68330524

Biography 　　True: 68330524

Contact address: Room 807, Zhongyi Building, No. 6, Xizhimenwai Street, Beijing

Postal code: 100044

Seven, the implementation phase, specific steps and requirements of cleanup

The clean-up of the medical device industry standards is divided into five stages: centralized confirmation of standards, evaluation clean-up, data collection and sorting, online publicity, and announcement of the final clean-up results. The detailed implementation rules of each stage will be notified separately.

(1) Standard centralized confirmation stage

Task: Centralize all current medical device industry standard items to the corresponding technical committee or technical focal point.

Time: about 1 month

1. According to the standard catalog issued by the preparatory group, the technical committees analyze and confirm the corresponding centralized management standards according to their work areas, and report the list of centralized management standards to the preparatory group before May 31.

2. The preparation team summarizes the reported results and submits them to the Medical Device Department for confirmation.

3. For medical device industry standards that have no jurisdiction after being confirmed by the Technical Committee, they shall be abolished in principle after publicizing no opinions. If relevant technical committees believe that there are industry standards that retain value, re-determine the focal point and clean up as required.

(2) Evaluation cleanup stage

Task: Each technical committee analyzes and evaluates the medical device industry standards under its jurisdiction one by one as required, and puts forward suggestions for the continued validity, revision, integration, abolition, and change of the standard attributes.

Time: about 5 months

1. For each industry standard, each technical committee shall organize five experts who are familiar with the standard project to conduct evaluations in accordance with the requirements and make clearing conclusions.

2. The Secretariat of the Technical Committee draws an overall conclusion, and reports the evaluation results to the preparatory group as an official document in accordance with the prescribed format and requirements.

(3) Data collection and arrangement stage

Task: The preparation team summarizes the results of the cleanup data and sorts them. For the objectionable items, opinions on handling shall be put forward after coordination. Submit to the Medical Device Department for confirmation.

Time: about 3 months.

(4) Online publicity stage

Task: The Department of Medical Devices will publish the clean-up results on the Internet and listen to the opinions of all parties.

Time: 2 months.

(5) Announce the final cleanup results stage

Coordinate according to the opinions of all parties, determine the final cleanup result, and announce it to the public.