China NMPA Registration

Just found there is less information about China NMPA medical device registration. I have been in this area over 10 years. If anyone have question about China medical device registration, I believe I could help you a lot.

 

Here is to introduce China NMPA registration basic. Here are some milestone you need to do:
1. Before submission:
1.1 Testing
1.2 Documents preparation
1.3 Clinical evlauation
---> Above 3 thing could be done in paralle
---> Time cost: Est. 6 months
2. Submission
---> NMPA will check the format firstly. Some documents need notarization.
---> Time cost: Est. 1 months
3. After submission:
3.1 1st round technical review
---> Time cost: 3 months for class II, 4 months for class III
3.2 Supplementary notice
---> NMPA issue questions. You need to answer
---> Time cost: You have 1 year to answer all questions. Normally take 6 months
3.3 2nd round technical review
---> Time cost: 3 months
4. Approval
---> Time cost: 2 months

Total time cost estimation: 22 months

Some devices are with high risk while the others are with low risk. So normally we could estimate 1.5 ~ 2 year to get the approval.

 

You need to test your device in China testing lab. The testing will perform according to a file called PTR, it's short for Product Technical Requirement.

PTR compiling is based on device's specification, related standards. Here you need to know that some Chinese standards are identical to IEC, ISO standards while some are different. Additionally, there are some Chinese standards which has no corresponding IEC/ISO standards.

If you want to pass the testing in China, 1st you should identify applied standard and analyze the differences between Chinese standard and IEC/ISO standards.

 

China NMPA registration uses electric submission system. All document submit through a software called eRPS. It has 6 chapters and the applicant should submit corresponding documents according to the requirement.

If you already have experience of US FDA or EU MDR, you will find 80% documents are similar. For the rest part you could work with your China colleague to finish them.

 

UDI in China
Based on NMPA regulation, all class III devices need UDI for registration. But for Class II devices, only part of devices need UDI.

 

Clinical Evaluation
You need to confirm your clinical evaluation path before you start the registration work. Some devices don't need clinical evaluation, while some devices need. You could find it in clinical evaluation exemption list.
If your device is not in this list, then you need to do clinical evaluation. And you have two options to prove the effectiveness. One way is to find a similar product to compare, the other way is to do the clinical trial. Or you could combine two ways.

 

Classification
NMPA definate medical device in class I, II, III. Class III is with the highest risk. There is a catalogue you could check to confirm your device's classification. This catalogue list the composition description, intended use, example names, so you could check if the description is your device.

But sometimes, your device is different, or cannot 100% match to the catagolue, then you may need to do classification. Correponding NMPA department will tell you the classification then you could apply based on the classification result. (But for import device, I mean the device is manufactured out of China, no matter it's class II or class III, the documents requirements are same.)

 

Except traditional registration path, there are some other paths:

1. Innovative MD Path

2. Emergency MD Path

3. Priority MD Path


Innovative MD

- Normally this is the GREEN Channel my friends talked about. They think this may shorten the reviewing process, but no… Let’s think about it. It’s an innovative medical device, there must be more uncertainty about safety or effectiveness. Then NMPA will be very careful about this kind devices’ approval. Then what’s the advantage for this path? NMPA will arrange one reviewer for you as contact window. You could communicate with the reviewer about technical and clinical question, EVEN BEFORE SUBMISSION!!! If you prepared all documents & evidence after consultation with reviewer, you sure can get the approval. This is the advantage


Emergency MD

- To be honestly, I don’t want to have this kind device in my hands. If I have, there must be some bad things happening, such as SARS, COVID-19, etc.



Priority MD

- When you submit the dossier, you could also prepare document for priority review. If pass, this could shorten the reviewing process. For example, your device should be the 30th in the line, if it meets priority review requirement, it may jump to the 1st

- Here is the link. You could check the requirement. But not easy.

(https://www.cmde.org.cn/sqrzc/zxfw/lcjteng/lcjtengyx/index.html)