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China Medical Device and IVD Registration FAQs: What Foreign Manufacturers Need to Know About NMPA Requirements
While China’s regulatory framework is well defined, many overseas companies still encounter uncertainty around classification rules, Chinese technical standards, Product Technical Requirements (PTR), labeling obligations, type testing, and certificate renewals. With these common challenges in mind, the following FAQs address the issues foreign manufacturers most frequently encounter when preparing products for approval by the National Medical Products Administration (NMPA).
Many of these questions arise when companies apply familiar EU or U.S. regulatory assumptions to the Chinese system—only to discover that several requirements differ in important ways. Clarifying these differences early helps manufacturers avoid delays, unnecessary testing, or incomplete documentation during the registration process.
Continue below for answers to the most common NMPA medical device registration questions, or contact Cisema today for expert assistance navigating China's regulatory pathways.
Chinese Standards and Classification
Before submitting a registration application, manufacturers must first understand how China defines medical device risk classes and which national standards apply to their product. Because China maintains its own regulatory standards system, companies cannot assume that classifications or testing frameworks from other markets will directly apply.
The following questions address how manufacturers access Chinese standards and how overseas products are categorized within the NMPA system.
Where can we access Chinese medical device and IVD standards in English?
There is still no official electrical version for standards. All Chinese standards are only available in paper for sale. All standards are sold only in paper format. We can translate relevant standards into English and identify applicable standards for your particular product published by different governing bodies.
The NMPA occasionally publishes standards catalogues and guidelines, which can be a useful starting point. For example, please see our news item “2021 CHINA MEDICAL DEVICE STANDARDS CATALOGUE RELEASED”.
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.
What does it mean to submit an extension application for an NMPA medical device registration certificate?
An extension adds a new model to an existing certificate. The functional scope of the new model must not exceed that of the originally registered device.
If you would like to explore the topic in more detail, see our in-depth resources:
- IVD Risk Classification in China: Regulatory Guide for Manufacturers
- Medical Device Risk Classification in China: Complete Guide
Labeling and Documentation Requirements
Once classification and applicable standards are clear, manufacturers must prepare documentation that aligns with China’s regulatory format. Two areas frequently raise questions: Chinese labeling requirements and the structure of the Product Technical Requirements (PTR) document.
The following FAQs clarify how these documentation elements function within the NMPA approval system.
What are the NMPA requirements for Chinese medical device labeling if certain data cannot be printed?
All medical devices or their packaging must include standardized Chinese labeling. If space is limited, the label must at minimum include: product name, model/specification, production date, shelf life or expiry date, and 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.
How detailed must the Product Technical Requirements (PTR) be for NMPA medical device registration?
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. It lists the technical parameters and applicable Chinese standards for the device. Test methods and test reports do not need to be included in the initial PTR; instead these are 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 during a product change or extension application?
Both the registered device and the new model require their own PTRs. Each PTR must fully list parameters and applicable Chinese standards.
Combination Products
In some cases, a product contains both pharmaceutical and device components. These drug–device combination products follow a different regulatory pathway from standard device registrations.
Understanding how the NMPA evaluates these products helps manufacturers determine the correct submission strategy.
How are drug–device combination products regulated in China by the NMPA?
Combination products are classified by the NMPA Standardization Management Center, established in 2019. Items such as pre-filled syringes with auto injectors are often regulated as drugs, with the syringe typically requiring a drug master filing (DMF).
Combination products considered medical devices might include: Drug containing intrauterine device, drug-containing coronary stent, and drug-containing coronary balloon catheters.
The biggest differences between medical devices and combination product registration include:
- Longer technical review due to involvement of the Drug Evaluation Center
- More testing items and higher costs
- Additional drug-related application documents
There are also combination products under drug classification. Such combination product must be applied to NMPA for classification as the first step. NMPA will then 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
Testing, Exemptions, and Renewals
Beyond documentation preparation, manufacturers must also address operational regulatory requirements such as type testing, clinical trial exemptions, and certificate renewals. These administrative steps often determine how efficiently companies maintain regulatory approval in China.
Which website can we check for China NMPA-registered medical devices and IVD products?
The NMPA maintains a medical device registration database (Chinese only), useful for checking both your own registrations and other manufacturers’ products: NMPA database
Is the original NMPA certificate required for renewal, or is a copy acceptable?
The original certificate is preferred for renewal applications. However, renewals may still be possible using only a copy. Please contact us if you would like to learn more or engage us for this service.
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.
Do manufacturers receive notifications when PTRs and IFUs are submitted through the NMPA disclosure system?
Yes. Manufacturers are notified and may redact confidential information.
Why doesn't China accept foreign testing?
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.
Final Thoughts
For many foreign manufacturers, the challenge of China medical device registration is not the existence of clear rules, but understanding how those rules differ from familiar regulatory systems.
Questions about classification, Chinese standards, PTR documentation, labeling formats, and testing requirements often arise once companies begin preparing an application. Addressing these issues early helps manufacturers avoid costly delays and ensures the registration dossier aligns with NMPA expectations from the outset.
If your team is preparing for Chinese market entry or reviewing an existing China registration strategy, experienced regulatory guidance can significantly streamline the process. Cisema supports international manufacturers with expert NMPA medical device and IVD registration services, helping companies interpret requirements, coordinate testing, and manage submissions to bring products to the Chinese market efficiently.
Further Information
Explore Cisema’s services for medical device registration in China
Manufacturers seeking deeper guidance on China’s regulatory framework may find the following resources helpful:
- Learn all about China's regulatory terminology in the China Medical Device Regulatory Glossary
- Understand classification rules with these detailed explainers:
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