Since 2015, more than 100 regulations and laws have passed from the central government mandates to CFDA requirements biggest shakeup since 2000. The changes impact not only premarket submission but also registration process evaluation, distribution management, promotion and post market monitoring.
The lefty fee implemented for imported devices (Class II=$34,000, Class III= $49,000) in May 2015 coupled with the requirements for CER or CS, small medical device manufacturers will have to be creative to find their ways for approval in China if their devices are not on the CFDA exempt lists. Days of getting class II premarket submission approvals in 6 to 9 months are gone in $20K are gone. Wrong claims could be penalized. 1st round of unannounced clinical trial study inspection completed. 2nd around is coming.
After attending 3 days of CFDA annual meeting in China, there are several areas that are worth highlighting. I will focus first on the top changes in the Registration System of Medical Devices under New Regulations that were summarized by the chief of CFDA at the plenary session.
- Class I medical device products require filing with CFDA.
- Three types of Registration Application: initial registration, re-registration and registration changes.
- Registration application data: consistence of domestic and foreign products, clinical evaluation, and technical requirements etc.
- Clinical Trial requirements and the approvals with high risks.
- Encourage innovation and fast path of innovative medical devices.
So what does all these mean if you are a small U.S. medtech company? You need to be more strategic about your entry and growth in China and contact us for answers to at least some of these questions.
- Determine whether you should pursue new foreign or domestic registration? China Healthcare 2025 are favoring domestic made products in public tenders. Domestic path could be faster.
- How do you qualify and select which types of registration? Should you simply turn over all the FDA cleared list of products or should you customize it for China?
- If your device is not on the clinical trial exempt list, CER will be the next better alternative than CS. But CER needs CFDA approved predicate device. If you are new to China, you certainly do not have the predicate device, so what do you do to avoid a complete clinical trial even though your products have been on the market in the U.S. for many years?
- If you are out of luck, you have to do clinical trial, in addition to mainland China, there are sites approved in Taiwan and soon in HK that CFDA will accept. But the entire process of EC committee, hospital approval, CS design and stats, patient recruit and management, site monitoring, data/form collection and integrity…… You should make sure that you find experienced people with proven medical device CS track records.
- Whether you are a MNC or a start-up, the innovation path could be a faster and more cost effective way to enter the market in China.
In a nutshell, only 100 ~reviewers at CFDA in China vs 1,000 ~ in FDA in the U.S. means that you should NOT simply entrust your FDA dossier to one of the thousand registration agencies/agents in China. You should find the seasoned agency who understand the differences between FDA and CFDA requirements for your device, who can provide the strategic guidance on how to leverage the new changes in regulation to achieve your business objectives!