Notice on Soliciting the Pre- project Proposal for the Unique Identification Standard of Medical Devices in 2023

To. All relevant units and individuals:

In order to cooperate with the implementation of the unique identification system for medical devices, do a good job in the pre-project establishment of the unique identification standard in 2023, in accordance with the Administrative Specifications for the Formulation and Revision of Medical Device Standards (Announcement No. 156 [2017] of the NMPA) (hereinafter refer to as the Specifications) , is now open to solicit proposals for the 2023 unique identification standard pre-approval. The relevant matters and requirements are hereby notified as follows:

 I. Scope and requirements of pre- project proposal

i. Scope of pre- project proposal
Basic general standards related to the unique identification of medical devices, focusing on the key technical difficulties in the implementation of the unique identification, such as the implementation of various levels of packaging, multi code parallel operation mode, etc.

ii. Requirements of pre- project proposal

   (i)  The proposal shall comply with the provisions of article 5 of the Specification;

（ii）The proposal shall be based on the demonstration of necessity and feasibility, including the maturity of preliminary pre research work and relevant technology, and the working basis of relevant professional theoretical research and experimental technology of the unit;

（iii）. The proposal shall include a complete draft standard or technical outline.

II. Matters related to proposal submission

i. Relevant production and operation enterprises, users, regulatory authorities, testing institutions, relevant educational and scientific research institutions, social organizations and individuals can put forward standard pre project proposals in this technical field.

ii. The deadline for project proposal solicitation in 2023 is May 31, 2022. The proposing unit or individual is requested to submit the proposal form for medical device standard establishment (see Annex) and complete standard draft or technical outline in electronic and written form before the deadline. Project proposals received after the deadline will be postponed to the next year.

Centre for Medical Device Standardization Administration NMPA

March4，2022

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