The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
Relaxed Regulation on Innovative Medical Devices
Innovative medical devices are defined as new technologies which are not currently available in China. Currently, all imported devices marketed in China must have regulatory approval in their country of origin as a precondition of CFDA registration. The new draft will remove this requirement for designated Innovative Devices only – manufacturers will no longer have to provide proof of overseas marketing approval or of overseas sales. The relaxed regulation reflects China’s determination of promoting the application of medical technology innovation so that more Chinese patients can benefit from new medical inventions. It’s now an option for manufacturers to strategically target China for first regulatory approval globally without taking a detour.
Abolition of Mandatory in-China Type Testing
For registration of Class II or Class III devices, the type test reports issued by authorised local testing institutions will become now optional. Manufacturers will be able to choose to take the conventional in China testing route or alternately to submit test reports and certificates from accredited third-party testing institutions and in some cases, possibly supported by in-house data. However, the provision of more freedom does not mean CFDA is lowering the bar of approval. Manufacturers must still establish a Chinese Product Technical Requirement – a core document in the CFDA registration submission – which draws on Chinese national and industry standards.
Conditional Approval of Urgently Needed Medical Devices
The revised Order 650 introduces a new pathway for the registration of urgently needed medical devices, such as those intended to treat rare diseases or severe life-threatening diseases with no effective therapy been available, or to deal with emergency public health events, CFDA can make conditional approvals with relevant conditions clearly stated on the registration certificates. This newly added regulation is trying to strike a balance between urgent demands of special medical devices and their supply, the speed of which may be greatly impeded by the regulatory hurdle imposed to ensure devices’ safety and performance in China.
The consultation period on the revisions is now over and we await CFDA’s final determination and publication of the new law. If previous track record is anything to go by, this should be complete within 2-3 months. Possibly in time for a Happy Chinese New Year!
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