China medical device registration

China medical device registration approvals are increasing each year. In 2021, 11,314 medical device registrations were approved, of which over 1,700 were new initial registrations. And roughly one third of all approvals were for IVDs. Please note that these numbers do not include class I and II domestic products because such applications are submitted to their respective provincial and municipal MPAs rather than the NMPA. 

The top five categories of medical device registered in 2021 were: 

1) Medical Imaging Equipment

2) Passive Implantable Devices

3) Dental Instruments

4) Neurological and Cardiovascular Surgical Instruments

5) Ophthalmic Devices.


So how do you register a medical device or in-vitro diagnostic (IVD) in China?

Below we outline the process of registering medical devices and IVDs in China in three simple steps.


Step 1: Appoint an NMPA Legal Agent

As a foreign manufacturer, your first step is to nominate a local authorized representative known as the NMPA Legal Agent. NMPA stands for the National Medical Products Administration and is the regulatory body responsible for medical devices and IVDs in China.

The NMPA Legal Agent is responsible for product registration, supervision of clinical tests, post-market surveillance activities amongst other activities. They are your point of contact and representative for all interactions with the regulator (NMPA) and so they should have a wealth of experience with relevant regulatory issues and product standards, as well as a good working history with the responsible authorities. 


Step 2: Determine the risk classification of your medical device or IVD

The next step is to determine the risk classification of your product. The risk class in your domestic or other countries can only serve as an indication; quite often the risk classification is higher in China than in the European Union or United States of America.

Your NMPA Legal Agent will check the medical device classification catalogue. If your product isn’t listed, then they will suggest a risk classification according to the Rules for Medical Device Classification.  

Where it is still unclear, then an official classification application can be made to the NMPA.


Step 3A: If your product is a Class I

If your product is classified as a Class I medical device or IVD in China, then you can submit a Class I filing application. It is a document-based process only involving:

- Preparation of the registration documents

- Writing the Product Technical Requirements (PTR) which is appended to the certificate when issued

- Notarisation and submission of documents.

The process typically takes between 2 and 4 months.


Step 3B: If your product is a Class II and III

If your product is classified as a Class II or III medical device or IVD in China, then you can submit a Class II or Class III registration application. This process typically takes 17 months for Class II and 21 months for a Class III products and involves: 

- Drafting the Product Technical Requirements (PTR) which is appended to the certificate when issued

Product type testing – these are tests to determine the performance and safety of your product against Chinese standards

- Preparation of a Clinical Evaluation Report OR results of a local Clinical Trial will be required as part of the registration (see below for further information) 

- Preparation and submission of registration application

- Response to any requests for supplementary information. 

Is a China clinical trial needed for my product?

As your NMPA Legal Agent we will determine whether an in-China clinical trial is required for your Class II or Class III medical device or IVD registration application. Firstly, we will check the clinical trial exemption catalogue which is updated every year or so. If your product figures on this exemption list, then a simplified clinical evaluation is sufficient. If not, then we will analyze your Overseas Clinical Trial Data (OCD) to see if they meet NMPA requirements. And finally, there may be the possibility of using a predicate or Real-World Data (RWD) to avoid in-China clinical trials. 



Let’s have a conversation about registering your medical device in China

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