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.
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. For example, please see our news item “2021 CHINA MEDICAL DEVICE STANDARDS CATALOGUE RELEASED”.
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.
An extension means that another model will be added on the certificate but this requires that that the function scope of the new model is not larger but must be same or less.
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.
There is a new department set up in 2019 that classifies combination products called the NMPA Standardization Management Center. For particular devices eg pre-filled syringes with auto injection, this will be likely considered a drug with the syringe requiring a drug master filing (DMF).
Combination products considered medical devices might include: Drug containing intrauterine device, drug-containing coronary stent, drug-containing coronary balloon catheter etc.
The biggest differences between medical devices and combination products are the following:
- The time of technical review is much more longer, since the Technical Review Centre of Drugs has to be involved into reviewing the documents of drugs
- There will be more test items and costs, since the drugs part needs to be tested accordingly
- There will be more application documents needed, since the drugs part needs to submit the relevant documents
There are also combination products under drug classification. And such combination product must be applied to NMPA for classification as the first step. NMPA will give a judgment whether it is combination product or drug within one month.
There are a number of recent announcements by NMPA and the regulation is fast-changing in this space, so check our news for the latest.
You may read further information here (in Chinese):
- Notice on adjusting the definition of the attributes of drug and equipment combination products (No. 28 of 2019) “drug-device combination products”
- Notice on registration of drug and equipment combination products (No. 16 of 2009) “drug-device combination products”
- Article 122 of the new measures for the administration of drug registration promulgated on July 1, 2020"
Available in Chinese only, but useful for checking up on your own or others’ product registrations: NMPA database
The original is preferred for a renewal application. However, we have experience with supporting customers apply for renewal even where only a copy is available. Please contact us if you would like to learn more or engage us for this service.
The PTR (Product Technical Requirements) lists all important technical parameters of the device and the related Chinese standards that cover these parameters. Test methods or 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.
For an extension the same rule applies for the PTR of the new and for the PTR of the registered device, so there are two PTRs with all parameters and Chinese standards.
It is simply the fact. The only testing completed outside China that is recognised by NMPA is for biocompatibility. We can evaluate if your existing biocompatibility test reports according to ISO-10993 complies with the latest requirements of China NMPA e.g. GB/T 16886. Please contact us if you would like to learn more or engage us for this service.
Case by case basis - it is up to the reviewer but often Zoom or similar calls are fine.
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.
Yes and they may redact confidential information too.