Where can we access Chinese standards in English?
The official English version of the standards is currently unavailable.
Are overseas devices always classified as Class II or III in China even if the device is Class I in EU/US?
No, the medical devices are classified according to the rules set by the China NMPA. Sometimes they would be stricter for better governance and control, however, domestic and foreign companies face the same requirements in China.
If I'm making an extension application to my NMPA certificate, what does this mean?
An extension means that another model will be added to the certificate, however, the intended function of the new model must not exceed the scope of the already existing model.
Labelling - our QA prohibits printing certain data information on the Chinese label, could we simply state that the user should refer to the English label?
Sure, it would be required in accordance with the Chinese regulations.
How are combination products regulated in China?
There is a new department set up in 2019 that classifies combination products. There are also some certain devices like pre-filled syringes with auto injection that would be considered as a drug product.
Combination products cover: Drug containing intrauterine device, drug-containing coronary stent, drug-containing coronary balloon catheter, etc.
Here are the differences between medical devices and combination products:
• The time of technical review for combination products would take longer, since the Technical Review Centre of Drugs will be involved in reviewing the documentations
• There will be more test items and costs involved, because the drugs need to be tested accordingly
• There will be more application documents needed for submission"
Helpful tips: Submit an application to the NMPA to confirm whether your product falls under the combination product category or drug product category (results available within a month).
• Notice on adjusting the definition of the attributes of drug and equipment combination products (No. 28 of 2019)
• Notice on registration of drug and equipment combination products (No. 16 of 2009)
• Article 122 of the new measures for the administration of drug registration promulgated on July 1, 2020
What is the NMPA website to check on products registered with the NMPA?
Do you need the original NMPA certificate or the copy would also be sufficient?
The original certificate is preferred for a renewal application. A copy can be sufficient, but it would be declared lost for changing the NMPA legal agent.
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. There are no test methods, test reports or testing details required at this stage.
What happens to the PTR with a product change or extension application?
The same rule applies to the PTR for new or registered device.
Why doesn't China accept foreign testing?
Currently, we do not have an official answer from the China authorities, however, they do accept overseas biocompatibility testing.
How do meetings work for the NMPA reviewers during Covid?
It depends on each case. Scheduling an online conference meeting is one of the options.
Can you share a copy of the exemption catalogue?
The exemption catalogue covers more than one single document. Leave us a message, so we can provide what you need in specific.
Do manufacturers get notified if their PTR and IFU are applied through the NMPA disclosure system?
Yes and to redact confidential information too.