1、 How does the government regulate the operation of medical device products?
1. The first category of medical devices does not require consent or registration, which means they can be directly sold as a type of product;
2. The second type of medical devices shall be subject to filing processing, and a request for filing shall be made to the food and drug supervision department at the city level where the device is located. After approval, the "Medical Device Operation Filing Certificate" shall be issued;
3. The implementation of the third type of medical device is subject to approval. After the materials are fully prepared, a request can be directly made to the food and drug supervision department at the city level where the district is located. After approval, a "Medical Device Operation Approval Certificate" will be issued.
2、 How long does it take to obtain the medical device operation permit?
1. Material acceptance: During the initial acceptance, if the requested materials are incomplete or do not conform to the legal form, the administrative personnel will inform the requester of all the required corrections within 5 working days. If the notification is not made within the deadline, it will be considered accepted from the date of receiving the requested materials;
2. Formal review: The food and drug supervision department at the district level shall review the requested materials within 30 working days from the date of acceptance and conduct on-site verification in accordance with the requirements of the medical device operation quality processing standards. If rectification is required, the rectification time shall not be included in the review deadline.
3. Certification time: For those who meet the prescribed conditions, a written resolution approving the consent shall be made in accordance with the law, and the "Medical Device Operation Consent Certificate" shall be issued within 10 working days.
3、 Will the drug regulatory bureau go to the scene to verify?
Within 3 months from the date of registration of medical device operation companies, the National Medical Products Administration will conduct on-site verification of Class II medical device operation companies in accordance with the requirements of medical device operation quality processing standards.
4、 To which department should a warehouse be set up across administrative regions be reported?
If a warehouse is set up across administrative regions, it shall be handled and filed with the food and drug supervision and processing department of the city level food and drug supervision and processing department where the warehouse is located.
5、 What are the relevant guidelines for establishing the demand for operating medical device products?
1. Operational processing guidelines that cover up the entire quality processing process
2. Guidelines for Purchasing Inspection Records
3. Sales record criteria
4. Self inspection criteria for quality processing (three categories)
5. Calculation information processing system (three types)
6、 Should the materials of the purchase inspection record criteria and the sales record criteria be retained?
1. The records of incoming inspection and sales shall be retained for 2 years after the expiration date of the medical device;
2. If there is no expiration date, it shall not be less than 5 years.
3. The records of purchase inspection and sales of implantable medical devices should be retained for a long time.
7、 What are the demands of medical device operating companies for upstream manufacturers?
Medical device operating companies should purchase medical devices from production or operating companies with talent.
Medical device operating companies should agree on quality and after-sales service responsibilities with suppliers to ensure the safe use of medical devices after sales.
A medical device operating company that has arranged with the supplier to provide product installation, repair, and technical training services may not have a part engaged in technical training and after-sales service, but should have corresponding handling personnel.
8、 What are the requirements of the operating company for the carrier?
If a medical device operating company entrusts other units to transport medical devices, it shall conduct an audit and evaluation of the quality assurance of the medical devices transported by the carrier, clarify the quality responsibilities during the transportation process, and ensure the quality and safety during the transportation process.
9、 Under what circumstances does the drug regulatory authority frequently visit the site for inspections?
（1） Serious doubts were raised during the previous year's supervision and inspection;
（2） Those who have been subject to administrative penalties for violating relevant laws and regulations;
（3） Newly established third category medical device operating companies;
（4） Other scenes that require on-site inspection by the food and drug supervision and processing department.
For medical device operating companies that may have product safety hazards discovered through complaints, reports, other information, and regular supervision and inspection, or medical device operating companies with records of misconduct, the food and drug supervision and handling department can implement flying inspections.
10、 How do you view the evidence of filing and the certificate of consent?
The pattern of the "Medical Device Operation Commitment Certificate" and the medical device operation record certificate shall be jointly formulated by the State Food and Drug Administration.
The "Medical Device Operation Commitment Certificate" and the medical device operation record certificate shall be printed by the food and drug supervision and processing department of the city level district.
The numbering method for the "Medical Device Operation Permit" is: XX Food and Drug Administration Medical Device Operation Permit No. XXXXXXXX. between which:
The first X representative agrees to the abbreviated names of some provinces, autonomous regions, and municipalities directly under the central government where they are located;
The second X represents the abbreviation of the municipal administrative region where the district is located;
The third to sixth X represents the 4-digit promised year;
The seventh to tenth X represents a 4-digit promised serial number.
The method for compiling the registration number of the second type of medical device operation certificate is: XX Food and Drug Administration Equipment Operation Record No. XXXXXXXX. between which:
The first X represents the abbreviation of the province, autonomous region, or municipality where the part of the case is located;
The second X represents the abbreviation of the municipal administrative region where the district is located;
The third to sixth X represents the 4-digit filing year;
The seventh to tenth X represents a 4-digit filing serial number.
11、 If An sells medical devices on the Internet?
The relevant handling regulations for Internet medical device operation shall be separately formulated by the State Food and Drug Administration. At present, this regulation has not been released yet. Internet sales is a major trend, and the introduction of standard regulations and guidelines is just around the corner.

This article comes from: http://www.kzyyl.com/