China’s medical and healthcare industry is second only in size to the U.S. on a global scale, The vast growth annually for Chinese medical devices has enjoyed increased expansion across the board and is expected to keep ascending over the next four years, which is largely due to population growth, and the rise in diseases, disorders and a aging society.
China is rapidly becoming a attractive market for foreign medical device manufacturing companies although there are some issues regarding partnerships between foreign manufacturers in regards to distribution of their products across China without foregoing certain aspects of their intellectual property (IP) rights.
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Registering for Imported Medical Devices in China
When foreign manufacturers want to import medical devices into China, they need to register their products. It requires a Medical Device Registration Certificate (MDRC) that can only be issued by the National Medical Products Administration (NMPA) which was formally known as the China Food and Drug Administration (CFDA).
The document is controlled by a local Legal Agent although it’s actually owned by the foreign manufacturer in question. However, the legal agent is responsible for the entirety of the application registration process, which means that these foreign medical devices need to be approved before they even attempt to apply for Chinese registration.
What is Medical Device Classification in China?
There is a number of medical device classification categories in China that you need to understand. The first one is the Low-Risk Class I level which is for medical devices that are subject to a filing procedure that must be followed in order to make an application with the NMPA. This process takes approximately 4 weeks to complete from the moment of application submission and is essentially an administrative review and MDRC issuance.
The next classification levels on the list are the Medium Risk Class II and High-Risk Class III categories for medical devices that need to be registered and submitted to the NMPA with an application and some supporting documents. These products need testing certificates that have been issued via a local NMPA-certified lab as a major requirement of the application process. Most Class II and III medical devices require clinical testing data on a local level.
When it comes to the authoritative bodies that are responsible in China for managing imported medical devices from foreign manufacturers, there are three main bodies: the provincial bureau, the municipal bureau, and the NMPA.
Foreign manufacturers will have to obtain a license for their medical devices in Class II and Class II categories. This license is better known as medical devices registration certificate. But if the devices are built by a domestic manufacturer, they need two licenses: the production license and the medical device registration license.
Any medical devices that come under Class I will be the responsibility of the foreign manufacturers who need to provide one kind of record, while any domestic manufacturers will need to provide two records that they are responsible for.
Local representation by a Chinese company is required by foreign manufacturers to become the Marketing Authorization Holder (MAH), which is a vital part of submitting a medical device registration.
What Requirements Do Foreign Manufacturers Need?
In the case of medical device companies that are not manufacturers in China, they need to provide samples of the device so the NMPA can perform proper testing.
If they are looking to register devices in Class II and Class III categories, the manufacturers are required to submit documents that prove their device has been tested and approved by the origin country, such as a CE Mark, an ISO 13485 certificate, an approved Premarket Approval Application that has been approved, or a 510(k) letter. Other documentation requirements may also be needed such as any proof of supportive clinical data that needs to be added to the application. Any product data or info on the packaging needs to be translated into Simplified Chinese.
The hiring of Chinese-based agents by the foreign manufacturers is a must because they are needed to represent their company interests in China. These agents have a number of tasks to undergo such as being responsible for providing any maintenance support or technical service in regard to the medical device while also assisting in matters related to device recall if required. The agent also needs to help oversee the registration process and also ensuring there is support in the event of a medical device malfunction.
Foreign medical device registration can be very complicated and fraught with potential issues that can cost time and money. Having someone on your side in China to ensure everything runs smoothly and above the law is not just helpful, but absolutely essential. We can help you to obtain the proper regulatory approval for any medical devices in China.
Our services include foreign investor company registration that covers HR outsourcing, Accounting & Tax compliance, business registration in China, and any other legal services you will desperately need. We are that tried and trusted Chinese agent on the frontline who is reliable, responsible, and extremely experienced in matters related to medical device registration in China.
