The American and the Chinese are the main medical devices market in the world. In these Countries the devices classification is different from the European one. How to proceed therefore to obtain the marketing authorization? Here is what we report from the AFI Symposium of 5-7 June 2019.
For what concern the USA, to commercialize the medical devices of class II and III and some of class I, the authorization by the Food and Drug Administration (FDA) is necessary.
For the majority of the devices the request occurs through the simplified Pre-Market Notification procedure, provided for by the section 510K of the Federal Food, Drug and Cosmetic Act. This procedure is based on the principle of equivalence: the device requesting the marketing authorization is made equal with one that has the same aim, the same mode of use and that is already legally marketed in the USA.
If, instead, no similarity is found, the Pre-Market Approval (PMA) procedure must be started.
A Request for Designation (RFD), a procedure to request not binding opinion, can be activated in case of doubts about the regulatory identity or about the classification of a product, namely if it is a device or a drug.
Also in China the marketing authorization of the national drug agency, the China’s Food and Drug Administration – CFDA, is necessary.
All devices must be registered through the regulatory system of the National Medical Product Administration – NMPA.
The devices of Class I must be notified to the Competent Authority; than the NMPA will issue the market authorization.
For the devices of Class II and Class III, instead, the question is more complicated: before the approval, the devices have to obtain the Registration Certificate through the execution of some test in labs located in the Chinese territory. All this, despite the fact that many foreign device manufacturers have already various clinical data to prove the safety and the effectiveness.
In addition the NMPA has recently issued new and significative regulations on classification, registration, inspections and clinical studies:
- “Regulations of the supervision and administration of China Authorized Representative for Imported Medical Device (Exposure Draft)”, which states that the China Authorized Representative, CAR, is the only person in charge of acting as legal intermediary between the MAH and the NMPA abroad.
- “Administrative Regulations of Drug and Medical Device Overseas Inspection”, that is the first regulation that clarifies the procedure and the responsibility for the inspection abroad. The NMPA will begin strict inspections of the manufacturing processes of all imported medical devices.