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