circular of the general administration of food and drug administration on the guiding principles for on-亚博bbin真人

the food and drug administration of the provinces, autonomous regions and municipalities directly under the central government and the food and drug administration of the xinjiang production and construction corps:

in order to strengthen the supervision and management of the quality of medical equipment operation, standardize and guide the on-site inspection of the quality management standards for medical equipment operation, the state food and drug administration has organized and formulated the guiding principles for on-site inspection of the quality management standards for medical equipment operation (hereinafter referred to as the following). referred to as the guiding principles, it is hereby issued.

the guiding principles shall apply to the on-site inspection of the business licenses (including alterations and extensions) of the wholesale/retail business enterprises of the third category of medical devices by the food and drug regulatory authorities, the on-site inspection of the business records of the wholesale/retail business enterprises of the second category of medical devices, and the various supervision and inspection of the medical device business enterprises. on-site inspection shall be conducted according to the inspection items included in the guiding principles and the corresponding key inspection contents, and the implementation of the "standards for the quality management of medical device operation" by the medical device trading enterprises shall be inspected. the medical device business enterprise may, according to the characteristics of its business mode, business scope and business varieties, determine the items which are reasonably missing, and explain the reasons in writing, which shall be confirmed by the inspection team.

in the on-site inspection of the business license (including alteration and extension) of the wholesale/retail business enterprise of the third kind of medical device, the business enterprise shall pass the inspection if all the applicable items meet the requirements. the number of key items that do not meet the requirements or do not meet the requirements in general items is more than 10% of the "failed inspection". the food and drug regulatory authorities shall make a written decision on whether or not to grant permission according to the examination situation.

all the key projects meet the requirements. in general, the number of non-conforming projects less than 10% is "rectification within a specified period of time". the enterprise should complete rectification within 30 days after the completion of the on-site inspection and submit a rectification report to the original examination department at one time. after reexamination, if all the rectification items meet the requirements, the food and drug regulatory department shall make a written decision on approval; if the rectification report is not submitted within 30 days or if there are still non-conforming items, the food and drug regulatory department shall make a written decision on disapproval.

the proportion of non-conforming items in general items referred to in this guiding principles = the number of non-conforming items in general items /(the total number of general items - the number of reasonable missing items identified in general items) * 100%.

in the on-the-spot inspection after the various supervision and inspection of the medical device business enterprise and the operation record of the wholesale/retail business enterprise of the second kind of medical device, the applicable items of the business enterprise are all conforming to the requirements of the "pass inspection"; and the items that do not conform to the requirements of the "rectification within a specified period of time".

if any violation of the regulations on the supervision and administration of medical devices and the regulations on the supervision and administration of medical devices is found during the inspection, it shall be dealt with according to the law.

after the inspection, the inspection team should fill in the "on-site inspection form of medical device management standards" and the "on-site inspection report of medical device management standards".