What Is the Classification of Medical Device Products? Come and Understand

According to Article 38 of the "Measures for the Management of Medical Device Registration and Records" (Order No. 47 of the General Administration of Marketing), the registered second and third categories of medical device products are designed, raw materials, production processes, scope of applications, use, and use. A substantial changes in the method may affect the safety and effectiveness of the medical device, and the registrant shall apply to the original registration department for the change of registration procedures; if other changes occur, the original registration department shall be filed within 30 days from the date of the change. According to the nature of product changes, the change is divided into the following three categories. Which three categories are it? Let's take a look together.

I. The contents of the registration certificate include the product name, model, specifications, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc. This class of changes belongs to the change of license items. The registration application should be submitted to the original registration department. Generally, technical review and administrative approval are required. If substantial changes occur, on -site assessment is required.

Second, the contents of the registration certificate include the name of the registered person and the residence, the name of the agent and the residence, the house number of the production address, etc. The change of this class is a change in the registration item and should apply to the original registration department for the filing of the change item

Third, the contents of the registration certificate include the production process and the content of the manual. This type of situation should be reported to the provincial pharmaceutical regulatory department where the provincial pharmaceutical regulatory department is located. Most provinces have implemented electronic declaration methods. However, the regulations of the application methods have different regulations. Generally, changes in production processes pass through major issues.