Is CFDA certification a medical device registration certificate? 

The State Food and Drug Administration, officially established on March 22, 2013, has the full name in English: China Food and Drug Administration, abbreviated CFDA. It is a directly affiliated institution of the State Council. It is the national government's pharmaceutical supervision and management department and is part of China's pharmaceutical administrative supervision management organization system. It belongs to the national pharmaceutical affairs management organization system.

As the competent department of medical devices, the State Food and Drug Administration (CFDA) regul related matters through the "Regulations on Supervision and Management of Medical Devices". ◾According to the Medical Device Production Supervision and Management Measures issued by the CF, any company that wants to establish a second-class and third-class medical device production enterprise in China must obtain a medical device production enterprise license. ◾According to Medical Device Registration Management Measures issued by the CFDA, any production company that wants to sell and use medical devices in China (including devices within and outside the territory) should apply registration with the corresponding food and drug supervision and administration department. In short, the CFDA is responsible for every process of the medical device industry, from production, sales to, and is the issuing authority for medical device products' [identification cards]. CFDA certification - Identification of medical device products Medical device registration refers the process by which the CFDA conducts a systematic evaluation of the safety and effectiveness of medical devices that are intended to be sold and used in accordance with legal procedures, in order to whether to approve their sale and use. Obtaining a [certificate] like CFDA certification is not as simple as getting an ID card for oneself. Medical device registration not only has a very complicated application process, but the requirements for the required supporting documents are also  very high, even for the registration application

Let's take a look, in general, what documents are needed to apply for a medical device product registration certificate:

() The applicant's business qualification certificate.

(2) Intellectual property status and proof documents of the product.

(3) A summary of the product research development process and results.

(4) Product technical documents, which should at least include:

1. The scope of application or intended use of the product;

2. The working principle or mechanism of action of the product;

3. The main technical indicators and their determination basis, the indicators required for the main raw materials and key, the main production process and process flow chart, and the inspection methods for the main technical indicators.

(5) Proof documents of product innovation, which should at least include

1. Academic papers, monographs, and document reviews published in core journals that fully explain the clinical application value of the product;

2. Analysis and comparison of application of similar products that have been listed in China and abroad (if any);

3. The innovative content of the product and its significant value in clinical application.

6) Product risk analysis materials.

(7) Product instructions (draft).

(8) Other documents proving that the product conforms to the provisions of Article2 of this procedure.

(9) A self-declaration of the authenticity of the submitted documents.