Notice of the State Food and Drug Administration Office on Launching a 2012 Medical Device Manufacturing Inspection

Food and Drug Administration of the provinces, autonomous regions, and municipalities directly under the Central Government (Drug and Drug Administration), China Food and Drug Authentication Research Institute, Drug Certification and Administration Center of the State Food and Drug Administration, Medical Device Technology Review Center of the State Food and Drug Administration, relevant Medical Device Testing Agency:

In order to further strengthen supervision and management of medical device production and promote the supervision and inspection of medical devices, according to the overall arrangements for the 2012 medical device supervision of the State Food and Drug Administration, it is scheduled to organize a flight inspection of medical device manufacturers in October 2012. The relevant matters are hereby notified as follows:

First, check the purpose

Further strengthen the supervision of medical device manufacturing enterprises, supervise and guide local supervision departments to effectively implement their supervisory duties, eliminate potential risks of regulatory risks and hidden dangers of product quality and safety, and continuously improve the quality and safety of medical devices.

Second, check the basis

"Administrative Measures for the Supervision and Administration of Medical Devices", "Regulations for the Daily Supervision and Administration of Medical Device Production", "Standards for the Quality Control of Medical Device Production (for Trial Implementation)", and "Procedures for the Flight Inspection of Medical Device Manufacturing Enterprises (Trial)".

Third, the scope of inspection

(1) As stipulated in the "Special Inspection on Production Quality Management System of High-Risk Medical Device Manufacturing Enterprises Concerning the Handling of Opinions of Enterprises" (Food and Drug Administration, Machinery and Equipment, No. [2011] No. 496), the State Food and Drug Administration will arrange Spot the company.

(2) As stipulated in the Circular on Strengthening the Supervision and Administration of the Use of Aseptic Catheters for Single Use (Food and Drug Administration Circular Letters [2012] No. 7), the State Food and Drug Administration will organize the implementation of flights according to specific conditions. Check the business.

(3) Others According to the "Procedures for Flight Inspection Work of Medical Device Manufacturers (Trial)", the food and drug regulatory authorities may carry out flight inspections.

Fourth, inspection work arrangements and requirements

(I) Selected Inspectors

The State Food and Drug Administration will select inspectors from the relevant provincial (district, city) bureaus and units according to the inspection work, and invite the selected units and individuals to actively support the inspection work and earnestly perform their duties.

(B) Inspector training

Before the inspection begins, the State Food and Drug Administration will organize a unified training for inspectors who participate in flight inspections.

(III) Implementation of inspections

1. The State Food and Drug Administration will timely notify the inspection company of the provincial (district, city) bureau inspection group of the relevant information arrived.

2. Please check with the local provincial (district, city) bureau of the company to send observers to assist in the inspection.

3. After the inspection team arrives, in the case of the scope of inspections (a) and (b), the provincial (district/city) bureau of the local government of the company to be inspected shall notify the inspection team of the implementation requirements of the documents and provide the daily supervision files of the enterprises to be inspected. For the inspection team to check; for the scope of the inspection (3), please check the provincial (district, city) bureau of the inspection company to provide the inspection team daily inspection files for inspection.

4. The inspection procedures were carried out according to the "Flight Inspection Procedures for Medical Device Manufacturing Enterprises (Trial)".

(d) Inspection summary

After the inspection is over, the State Food and Drug Administration will organize a summary meeting to hear inspection reports, determine the inspection conclusions, and study the treatment measures.

V. Other matters

(1) The expenses incurred by the inspectors on transportation, accommodation and food shall be borne by the State Food and Drug Administration.