12 November, 2018

Medical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard and industry standards and successive issuances of product guidance and administrative directives. With its 10-year experience in the registration of non-active medical device in China, Qualtech would like to share an overview of the common roadblocks of the registration process a foreign manufacturer frequently encounters. These issues were summed up into six frequently asked questions which are briefly explained in the succeeding paragraphs, along with our experience-based inputs with an intention to provide our readers with relevant approaches to solve these issues hereby identified.

In this article, we won’t talk about the basic information of registration process in China. If you would like to understand this basic information, kindly click on this link.

Does your product belong to an active device group? Please kindly refer to another article <6 Things You Have to Know When Your Medical Device Undergoes the China Registration Process: Active Medical Device Part>

1. If my product has many types, can I list all models under one license? This question often arises with manufacturers who produce consumables or implanted products. To be able to meet pressing market demands, they usually design multiple product models, with several variations in "size", "shape "," color, "product composition" or "materials". Each region has different regulations set for these permissible variants, whether multiple models with differing configurations may be included in one product license. From the review comments or guidelines issued by CMDE, we found that models with differences on the "clinical application sites", "product composition" or "chemical composition" must be split into different product licenses.

2. Can I choose a representative model to conduct the tests? This question is derived from the above query. If your product has multiple models, you need to be very careful when performing the tests. Generally, it is impossible to take all the models to test (or the financial department might knock your door and talk about the testing fee). Therefore, choosing a representative model is an important aspect. You have to evaluate whether this model could adequately represent all models in various tests, and consider about the strong reasons so that you can convince the reviewer. The problem we often encounter is about the multiple models in biocompatibility test report. When the model type of the product is divided by materials or ingredients, the manufacturer does not fully consider all the ingredients. The representative models in the biocompatibility test shall include all ingredients of the product. If not, the reviewer might concern whether the biocompatibility report can covers all models.

3. Is it enough to submit a sterilization validation report in order to verify that my product is sterilized? In the past two years, CMDE’s requirements for sterile products have become more stringent. In addition to the revised national standards for various sterilization modes, the draft of "Guideline for Sterile Medical Devices" was also released in September, which mentions that the applicant shall offer a logical and sufficient sterilization validation report in the registration application. It’s pretty obvious that NMPA is very particular on this requirement. If your product is sterile, we recommend you to take time pondering on the . This will help your company to quickly understand the latest requirements for sterilization issued by NMPA, and incorporate these requirements to your next sterilization validation plan.

4. Can I use the biocompatibility report of raw material instead of final product? For most manufacturers, designing a biocompatibility test plan for a product is a big nightmare. Not only that it’s time-consuming, but also economically draining. Some manufacturers will directly use the biocompatibility report from the material’s suppliers in order to save high testing fee. However, NMPA may not recognize such reports. Based on the latest public comments on CMDE website, the current reviewing strategy is mainly focused on the biocompatibility tests conducted on the final product. In other words, if your company intends to use the final product for biocompatibility test, it is important to consider whether the sampling is representative. If your company intends to make a special sample for testing, then you not only consider the representative problem, but also concern whether the sample is identical to the final product.

5. Does NMPA take care the control of raw materials? Compared with active devices, reviewers will pay more attention to raw materials when reviewing non-active devices, especially if your product is composed of multiple ingredients or components. In addition to the ingredients, the plasticizers and adhesives used in manufacturing are included in the list of raw materials. NMPA would like to know the sourcing of the materials and the certificate of the supplier. If the materials are approved by international standards, then NMPA may be assured, if not, they would consider the performance of your product and ask for other reports to ensure the safety of the product at the material level.

6. How to avoid conducting clinical trial in China? There are two ways to exempt clinical trials in China:

1) Compliance with the catalogue of the device exempt for clinical trial, and

2) comparison of the same variety of products listed in China.

NMPA has issued the latest version of the catalogue of the device exempt for clinical trial in September this year comprising of 855 medical devices and 393 in vitro diagnostic reagent products. The device may be exempted from clinical trial for as long as it is similar to any product listed in the catalogue, in which case you may just have to submit supplementary information about the competitor product which is also registered in China. If there is no any similar device on the catalogue, NMPA also provides another route- comparison of same variety of products, where you only need to obtain the authorization of the manufacturer of similar products listed in China, and compare several necessary information with the equivalent device and analyze published clinical literatures in order to verify the safety and performance of the product. In the latter case, there is still a very high possibility for the device to be exempted from clinical trials.


1. CFDA official website 

2CMDE official website