In order to strengthen the supervision and management of medical device operation quality, standardize and guide the on-site inspection of medical device operation quality management norms, according to the "Medical device operation quality management norms", China Food and Drug Administration has formulated the "Guiding Principles for on-site inspection of medical device operation quality management norms" (hereinafter referred to as the "Guiding Principles"), which are hereby issued.
The Guiding Principles are applicable to the on-site verification of the business licenses (including changes and renewals) of Class III medical device wholesale/retail enterprises by food and drug supervision departments, and the operating equipment of Class II medical device wholesale/retail enterprises.
On-site verification after the case, as well as various kinds of supervision and inspection of medical device business enterprises. During on-site inspection, medical device enterprises shall be inspected according to the inspection items and corresponding key inspection contents listed in the Guiding Principles.
Check the implementation of the Quality Management Standard for Medical Device Management. Medical device business enterprises can determine the reasonable missing items according to the characteristics of their business mode, business scope and business varieties, and explain the reasons in writing.
The team confirmed.
In the on-site verification of the business license (including change and extension) of the third category of medical device wholesale/retail enterprises, all the items applicable to the enterprises meet the requirements are "qualified".
Check. "If there are key projects that do not meet the requirements or the number of projects that do not meet the requirements in general projects is > 10%, it is considered as' unqualified inspection'". The food and drug supervision department shall make a written decision on whether to approve the license according to the review.
All key projects meet the requirements, and the number of unqualified projects in general projects is ≤ 10% as "rectification within a time limit". The enterprise shall complete the rectification within 30 days after the on-site inspection, and submit the rectification to the original examination department at one time.
Change the report. After examination, if all the rectification projects meet the requirements, the food and drug supervision department shall make a written decision to approve the license; Failing to submit a rectification report or review unqualified items, food and drugs within 30 days.
The product supervision department makes a written decision not to grant permission.
The proportion of unqualified items in general projects referred to in the Guiding Principles = unqualified items in general projects/(total number of general projects-reasonable missing items confirmed in general projects) * 100%.
In all kinds of supervision and inspection of medical device operating enterprises and on-site verification of second-class medical device wholesale/retail operating enterprises after operation, all the items that meet the requirements applicable to operating enterprises are "qualified"; Any project that does not meet the requirements is "rectification within a time limit".
In case of violation of the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Devices, it shall be dealt with according to law.
After the inspection, the inspection team shall fill in the On-the-spot Checklist of Medical Device Management Quality Standards and the On-the-spot Inspection Report of Medical Device Management Quality Standards.