When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and wealthier. China accounts for 1/5 of the world’s population – about 1.3 billion people. Most marketing departments feel that this huge market is worth the incredible effort that it takes to register medical devices. China registration is therefore usually in the international registration strategies for most large medical device companies.

Many aspects of the China registration process are unique to China. In this blog post I want to talk about the basic differences between Chinese Domestic and Chinese Imported registrations. In China, the type of registration depends on where the product is manufactured (the country of origin, not the location of the legal manufacturer). If the product is manufactured in China, it is registered through a local branch of the SFDA and is considered a “Domestic” (also called “Provincial”) registration. If the product is made outside of China, it is registered through the federal branch of the SFDA and is considered an “Imported” (also called “Federal”) registration. These two types of registration can be so different; it is almost like registering in two different countries.

Domestic registrations generally take longer and are more difficult than imported. They require a Medical Device Manufacturing Enterprise License and a Product Registration Certificate (imported products only require the Product Registration Certificate). The philosophy of Chinese government is that they should have more say in material that is manufactured within their borders. Clinical trials are more often needed for domestic registrations. I have even had to change the format for the Simplified Chinese Instructions for Use to meet the desires of the Local SFDA during a Domestic Registration. There was no regulation that required us to change the format – the SFDA did not want any change to the IFU content, only the order in which the material was presented. The change required was purely an aesthetic request, but the product could not be registered otherwise. I have found that the local SFDA tries to exercise more control over the product than the federal SFDA.

Another major difference: Domestic registrations can be “bundled” - similar product lines can be rolled together into an existing certificate. These bundling registrations can greatly reduce the time required for registration from years to weeks. We try to do it as much as possible for this reason. Imported products do not have a “bundling” option, but have a separate certificate for each product line. The down side of the “bundling” registrations is that they can wreak havoc with the Chinese labeling requirements. But don’t get me started on the Chinese labeling requirements - that is a great subject for my next blog post!!

- Daria

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