What is the meaning of medical device filing number?
Medical device filing number is the approval lot number of medical devices or products such as plasters for health care effects. It is a medical device product. Does not belong to the drug, is a medical device. Is a low degree of risk, the implementation of national routine management can ensure its safety and effectiveness of medical devices.
Mechanisms that have clinical efficacy can be written directly on the manual, are tested by the clinical view. The product is more secure, and is filed by the State Food and Drug Administration.
A class of medical devices need to go to the Drug Administration for the record?
No need. According to the new supervision and management of medical devices, the operation of Class I medical devices do not require licensing and filing; the operation of Class II medical devices for the record management; the operation of Class III medical devices for licensing management, so only the operation of a class of medical devices is not required to record, the production of Class I medical devices are required to record.
Legal basis: "supervision and management of medical devices"
Article 3 of the State Food and Drug Administration is responsible for the supervision and management of the national medical device business. Food and drug supervision and management departments at or above the county level are responsible for the supervision and management of medical device business in the administrative region.
The higher-level food and drug supervision and management departments are responsible for guiding and supervising the lower-level food and drug supervision and management departments to carry out supervision and management of medical device business.
Article IV in accordance with the degree of risk of medical devices, medical devices business implementation of classification management.
The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices license management.
How to check the record of medical devices?
The State Drug Administration web page medical device product query portal can be viewed!
Can I enter hospitals and pharmacies?
Most of the medicine of the armament size of the cream, you can enter the pharmacy, the formalities to be complete, the hospital can also enter the, but ask the three A is difficult, the general hospital can
Strictly speaking, with a medical device business license of the pharmacy or medical device company can sell armament size of the drug, and then your variety of the health care system bidding in the bidding, you can also go into the hospital to sell.
Pharmaceutical representative of the record on behalf of the impact?
The biggest impact is that the casual flow of pharmaceutical representatives to replace the relatively large restrictions, a direct decision on the pharmaceutical representatives previously composed of part-time personnel, and now must be set to a full-time staff of significant changes