Is a manufacturing license required to produce materials for prosthetic-orthotic devices?

Category: Healthcare

Description of the problem:

If so, which department issues the license? How do I get a license?

Answer:

The term "materials used in prosthetic-orthotic devices" should be "materials used in prosthetic-orthotic devices".

The materials used in prosthetic-orthotic devices belong to the medical device, the production of such products must first obtain the "medical device manufacturer license", and then obtain the variety of "registration certificate", the main two certificates are issued by the provincial Food and Drug Administration. The license should be applied for by the applicant situation, the specific procedures vary from province to province, please refer to the State Council's "Regulations for the Supervision and Administration of Medical Devices", and to the location of the provincial Food and Drug Administration Medical Devices Division consulting.