In May 2015, NMPA issued Technical guidelines for Clinical Evaluation of Medical Devices. For the Class Ⅰ/Ⅱ products not listed in the clinical investigation exemption catalogue of medical device，there are two measures for pre-marketing approval: 1. Clinical evaluation. The clinical materials are also called comparative report on the products with same classification, clinical evaluation report, clinical equivalence evaluation report. 2. Clinical trial. We will check both measures one by one and choose the best according to the specification of the products. The following items refer to the products which need to be registered by the measure of clinical evaluation report.

1. Localization of imported products

2. Renewal of registration is delayed and result in re-registration.

3. The certificate need to be replaced because of the information such as manufacturer changed but no change of the product.

4. The product treated as the subsequent model to the product that has been released on the market and produced by the same manufacturer.

5. The products manufactured in extra plant by the same manufacturer which has released same products on the market.

6. There is no previous model and similar product manufactured by the same manufacturer. But the authorization and technical data of similar product manufactured by the other manufacturer are available.

7. The characteristic, risk level, safety and effecacy of the product without previous model released on market can be proven by clinical evaluation report (CER).

Compared with unpredictability of clinical  invetigation result, clinical evaluation report is based on the clinical literature, clinical data, adverse event data of the similar product, which used to judge whether a product can meet the requirements or intense use, and confirm duraion of intense use is low-risk and shorten. After new regulation issued in 2015, MedicalStrong has established a team for clinical equivalence evaluation. All the members of it have Master degree about relevant field and have minimum 5 years experience in developing clinical equivalence evaluation report. Until now, we have completed 50 cases of clinical evaluation reports for the products such as respirator,