The State Drug Administration's notice on issuing the results of the national medical device supervision and random inspection (No. 2)

The State Drug Administration's notice on issuing the results of the national medical device supervision and random inspection (No. 2)

(No. 35, 2022)

In order to strengthen the supervision and management of medical device and ensure the quality and safety of medical device products, the State Drug Administration organizes three varieties of surgical clothes, disposable use of abdominal puncture, small steam sterilizer, etc. Batch (Taiwan) products do not meet the standards.

1. Medical device products that are not complied with the standards stipulated in the sampling items

(1) 2 batches of surgical clothes: produced by Hongchang Biomedical Technology (Pinghu) Co., Ltd. and Xinxiang Changda Medical Device Co., Ltd., involving ethylene oxide residues and steriles do not meet the standards.

(2) A batch of one -time use of abdominal puncture: The production of Tianjin Jonenken Medical Device Technology Co., Ltd., involving the coordination performance does not meet the standards.

(3) 1 small steam sterilization device: The production of Foshan Zhongchuang Medical Device Co., Ltd., which involves a balanced time and maintenance time, does not meet the standards.

The above sample inspection does not meet the specific conditions specified in the standard.

2. For the above -mentioned products that do not meet the standards of standards, the State Drug Administration has requested that the provincial drug supervision and management department of the medical device registrar is located in accordance with the "Regulations on the Supervision and Management of Medical Device", "Measures for Medical Device Production Supervision and Management", "Medical Device Recall Administration Measures 》 The requirements of the administrative processing decision in a timely manner and announced to the society. Provincial drug supervision and management departments should urge medical device registrars to evaluate risk assessment of products that do not meet the standards of random inspection, determine the recall level according to the severity of medical device defects, actively recall the product and publicly recall information; The reasons for qualifying, formulate rectification measures and rectify on time.

announce.

Attachment: Smaller inspection does not meet the standard of the product specified product list

State Drug Administration

July 18, 2022

Attachment: Smaller inspection does not meet the standard of the product specified product list

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