NMPA Notice on Printing and Issuing the Guidelines for On-Site Inspection of the Good Supply Practice for Medical Devices

NMPA Department of Drug Supervision [2024] No. 20

To medical products administrations of all provinces, autonomous regions and municipalities directly under the central government, and Xinjiang Production and Construction Corps:

The revised Good Supply Practice for Medical Devices (hereinafter referred to as the Regulations) will be implemented as of July 1, 2024. To standardize and instruct the on-site inspection of the Good Supply Practice for Medical Devices, the National Medical Products Administration (NMPA) has formulated the Guidelines for On-site Inspection of Good Supply Practice for Medical Devices (hereafter referred to as the Guidelines), which is hereby printed and issued.

The Guidelines are applicable to the drug regulatory department based on the Regulations to conduct on-site inspection of distribution license (including change and renewal) of medical device distributors, and on-site inspection after distributing filing of medical device distributors, as well as additional various supervision and inspection of medical device distributors. During the inspection process, medical device distributors can determine the reasonable lacking items according to their distribution mode, distribution scope, distribution varieties, etc., and give the reasons in writing, which shall be confirmed by the inspection team of the drug regulatory department.

I. On-site inspection of medical device distribution license (including change and renewal)

During the process of on-site inspection of medical device distribution license (including change and renewal), for the distributor applicable items that all meet the requirements or can be rectified on-site, the inspection result shall be "passed"; if the number of non-compliant items in the key items (marked as “※” items) is ≤ 10% and the number of non-compliant items in the general items (unmarked items) is ≤ 20%, the inspection result shall be "rectified within a specified time"; If the number of non-compliant items in key items is > 10% or the number of non-compliant items in general items is > 20%, the inspection result shall be "failed".

If the inspection result is "rectified within a specified time", the distributor should complete the rectification within 30 working days after the end of the on-site inspection and submit a one-off rectification report to the original inspection department. If the review concludes that all rectification items meet the requirements, the drug regulatory department will issue a written decision to grant a license. If the distributor fails to submit a rectification report within 30 working days or the review concludes that there are still items that do not meet the requirements, the drug regulatory department will issue a written decision not to grant a license. If the inspection result is "failed", the drug regulatory department can directly issue a written decision not to grant a license.

In this Guidelines, the percentage of non-conforming critical items = Number of non-conforming critical items ÷ (Total number of critical items - Number of confirmed reasonable lacking critical items) × 100%; The percentage of non-conforming general items = Number of non-conforming general items ÷ (Total number of general items - Number of confirmed reasonable lacking general items) × 100%.

II. Additional supervision and inspection

During the process of daily supervision and inspection and on-site inspection after distributing filing of medical device distributor, for the distributor applicable items that all meet the requirements or can be rectified on-site, the inspection result shall be "passed". If any item does not meet the requirements and cannot be rectified on-site, the inspection result shall be "rectified within a specified time".

If, during the inspection, the distributor is found to have violated the relevant provisions of the Regulations for the Supervision and Administration of Medical Devices as well as Provisions for Supervision and Administration of Medical Device Distribution, it shall be dealt with in accordance with laws and regulations. Among them, if the non-conformity items found in the inspection affect or fail to ensure the safety and efficacy of the products, after evaluation by the drug regulatory department, they shall be dealt with in accordance with the provisions of Article 86 of the Regulations for the Supervision and Administration of Medical Devices, and Articles 22 and 24 of the Provisions for Supervision and Administration of Medical Device Distribution, in accordance with the laws.

This Guidelines shall be implemented as of the date of issuance. The Guidelines for On-Site Inspection of the Good Supply Practice for Medical Devices (CFDA Department of Medical Device Supervision [2015] No. 239) issued by the former China Food and Drug Administration is annulled simultaneously.

National Medical Products Administration

July 30, 2024