The Comprehensive Department of the State Drug Administration of the State Drug Administration on agreed to build a recovery letter of the reliability and maintenance of the reliability and maintenance of medical equipment

The Comprehensive Department of the State Drug Administration of the State Drug Administration on agreed to build a recovery letter of the reliability and maintenance of the reliability and maintenance of medical equipment

Pharmaceutical Supervision Comprehensive Removal Note [2022] No. 329

Standard Management Center for Medical Device Standards for the State Drug Administration:

Your center's "Letter to apply for the Related Materials Related Materials of Reliability and Maintenance Standardization Technical Standardization Technology of Medical Devices" (National Wealth Bid Management Letter [2022] No. 15), "Regarding the standardization of reliability and maintenance of medical equipment "The letter of materials supplementary materials of the technical port" (National Wealth Bid Management Letter [2022] No. 104) received it. After research, the following opinions were put forward:

I. According to the relevant provisions of the "Administrative Measures for the Standards for Medical Devices", we agree to organize the establishment of medical device reliability and maintenance standardization technical export units.

2. The relevant procedures and requirements of the preparation work are as follows:

(1) Formulate an expert composition plan. The preparatory units solicit candidates for experts in accordance with the principles of extensive participation of relevant parties, and encourage experts, scientific research institutes, and experts from clinical institutions to participate, and improve the representative and extensiveness of members. The preparatory unit shall solicit members publicly on the unit and your center website. According to the collection situation, the preparatory unit and the relevant parties including the experts include the relevant parties to the relevant parties to formulate a plan for the formulation of an expert. Experts formed the relevant requirements of the "Administrative Regulations of the National Professional Standardization Technical Committee".

(2) Research standard areas and system frameworks. Relevant units and experts in the preparatory unit organize further research and demonstration of the professional fields responsible for the exporting unit, strengthen communication with other related technical committees, and propose the standard areas and system frameworks of the exporting unit.

(3) Submit the establishment of a standardized technical batch unit. The preparatory unit prepares to set up a plan material (see attachment) to report your center for review.

(4) Obstical announcement. After the approval of the establishment of the plan, your center should publicize the name of the portfolio, the list of experts, professional fields, international organizations, preparation units, and secretariat undertaking units. The publicity period is 30 days. When the publicity period is expired, if the requirements are met, your center will set up a plan to report to the State Drug Administration for approval.

Attachment: list of medical device standardization technology, the list of plan materials

Comprehensive Department of the State Drug Administration

June 16, 2022

appendix

Attachment: list of medical device standardization technology, the list of plan materials

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