Frequently Asked Questions about the registration of medical device and IVDs in China
Below you will find answers to questions we get asked by clients the most about registering medical devices or IVDs in China.
1 Where can we access Chinese standards in English?
There is still no official electrical version for standards. All Chinese standards are only available in paper for sale. We can translate them for you into EN and we can search for applicable standards for your particular product published from different governing bodies.
Occasionally the NMPA publishes lists of standards and guidelines. These can be a helpful starting point.
2 Are overseas devices always classified as Class II or III even if Class I in EU/US?
No, it depends on the device. There are many overseas manufacturers with Class I devices. However, the China classification system is more conservative than many other countries, so it is often the case that a class I product in the home country is class II in China. Both domestic and foreign companies face the same requirements.
3 Labelling - my QA prohibits printing of certain data on my Chinese label (I would like instead to simply state that the user should refer to English label).
All MD or their packaging must carry a standardized Chinese label. If the label has limitations in size it has to contain at least the following information: Name, model and specification of the product, production date, shelf life or expiry date, and the label must clearly indicate the phrase "see operating instructions for further details". Please contact us for our experts to check your label. We provide Chinese label templates for our registration customers.
4 What is the NMPA website to check on products registered with the NMPA?
Available in Chinese only, but useful for checking up on your own or others’ product registrations: NMPA database
5 How detailed does the PTR need to be - should it include testing features?
The PTR (Product Technical Requirements) lists all important technical parameters of the device and the related Chinese standards that cover these parameters. Test reports are not required in the initial PTR version – instead this will be covered in the test lab report.
The PTR guidance document relates to formatting features and generally intricate testing details won't be required.
The PTR is one of the most important documents for the China registration. It is annexed to the NMPA certificate and is equally important as the certificate.
6 Can you share a copy of the exemption catalogue?
This is not one document but a series of regulations released by NMPA/SAMR. Please contact us and we will check the clinical trial exemption catalogue for you.