Questions our customers have frequently asked us

Where can we access Chinese standards in English?
There is no official translation of Chinese regulations into English. Cisema translates some of the more frequently used depending on customer needs. Please ask us for more information.

Are overseas devices always classified as Class II or III even if Class I in EU/US?
No, depends on the device. There are many overseas manufacturers with Class I devices. Note that China classification system tends to be more conservative than overseas but domestic and foreign companies face the same requirements.

If I'm making an extension application to my NMPA certificate, what does this mean?
An extension means that another model will be added on the certificate but this requires that the function scope of the new model is not larger but must be same or less.

Labelling - my QA prohibits printing of certain data on my Chinese label (I would instead like to simply state that the user should refer to the English label).
Doesn't matter, Chinese regulations require it.

How are combination products regulated in China?
There is a new department set up in 2019 that classifies combination products. For particular devices eg pre-filled syringes with auto injection - this will be likely considered a drug with the syringe being a DMF.

Combination products considered medical devices might include: Drug containing intrauterine device, drug-containing coronary stent(for example Angioline), 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 the classification of drugs, and such combination product must be applied to NMPA for classification as the first step. Within a month time, the NMPA will make the final decision to determine whether the device would be considered as a combination product or drug product in China.

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)
    https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190531180601758.html
  • Notice on registration of drug and equipment combination products (No. 16 of 2009)
    https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20091112141901388.html
  • Article 122 of the new measures for the administration of drug registration promulgated on July 1, 2020"

Do you need the original NMPA certificate or is a copy only ok?
Original is preferred for a renewal application. However, we have experience in supporting customers to apply for renewal even where only a copy is available.

How detailed does the PTR need to be - should it include testing features?
The PTR 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.

What happens to the PTR with a product change or extension application?
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

Why doesn't China accept foreign testing?
We don't know - it is simply the fact. Note that it will accept overseas biocompatibility testing.

How do reviewer meetings work during Covid?
Case by case basis - it is up to the reviewer but often zoom calls are fine.

Can you share a copy of the exemption catalogue?
This is not one document but a series of regulations released by the NMPA/SAMR.

Will the manufacturers be notified when their PTR and IFU are being applied through the NMPA disclosure system?
Yes and they may redact confidential information too.

For more information or help, let us know by leaving a message.

We are at your disposal

Contact

Do not hesitate to contact us if you have further questions or to request a non-binding offer.
You can contact us at +1 (0)773-449 5169 (US & Americas) or + 49 (0)89-4161 7389-00 (EU and worldwide) or via email.

To obtain further relevant information we recommend you
to visit our knowledge area or our registration page for exclusive information brochures.

TOP