The Comprehensive Department of the State Drug Administration on agreed to build a re -letter of the

The Comprehensive Division of the State Drug Administration on agreed to the establishment of the standardized technical batching unit of oral digital chemotherapy equipment

Pharmaceutical Supervision Comprehensive Control letter [2022] No. 295

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Standard Management Center of the State Drug Administration:

Your Center \"For the application for the application of the standardized technology of the standardization of oral digital chemical equipment \"(National Wealth Bid Management Letter [2022] No. 130) Received. After research, the following opinions were put forward:

1. According to the relevant provisions of the \"Administrative Measures for the Standards for Medical Device\", agree with your center to organize the establishment of the standardized technical port unit of oral digital chemical equipment.

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

[1) Draw 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 a plan for the establishment of a standardized technology port unit. The preparatory unit prepares to set up a plan material (see attachment) to report your center for review.

(4) Public 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: The list of medical device standardization technology batch units forms a list of materials

] Comprehensive Department of the State Drug Administration

June 1, 2022

Annex

Attachment: The list of materials for the standardization of medical device standardization technology for the establishment of a plan and material list

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