The “Regulations for the Supervision and Administration of Medical Devices″ of March 7, 2014, have been in place for a little over a year. While facilitating the registration of low-risk devices, the new requirements for the registration of medical devices including in-vitro diagnostics (IVD) have introduced stricter requirements for medical devices in higher risk classes. Qiuyun Zhao, Coordinator Registration Affairs of TÜV SÜD PS in Beijing, summarizes the key changes.
Simplified registration process for Class I medical devices
Regulation of the market for medical devices and IVD in China falls under the responsibility of the China Food and Drug Administration (CFDA). While medical devices continue to be classified in one of three risk classes, the classification of some products and product groups may have changed. Registration processes and requirements differ according to risk class: low-risk medical devices (Class I) are generally entered in the CFDA database following an administrative review and may then be placed on the market.
Different registration processes for devices in Classes II and III
Before higher risk medical devices can be sold in China, they still have to undergo a relatively complex registration process, which may even include additional clinical trials. There are different processes for initial registration, renewal of registration and alterations to registration. In addition, all overseas medical devices, i.e. all devices imported into China, and all domestic medical devices in Class III must undergo technical review by the Center for Medical Device Evaluation (CDME) of CFDA.
Shorter processing periods
For the technical review, CDME allows 60 workdays for devices in Class II and 90 workdays for devices in Class III. After that, CFDA will decide on registration within 20 workdays.
Product tests and clinical trials in China
Product tests must be carried out on all devices. For Class I medical devices, manufacturers can present their own test reports, for example issued by TÜV SÜD Product Service. Devices in Classes II and III must be tested by accredited testing laboratories in China. A list provides information about which testing laboratories are accredited for which devices. In the case of product families, testing may be conducted on a representative type.
For medical devices in Class I, no clinical trial need be conducted. Medical devices in Classes II and III require clinical trials carried out in authorized clinical institutions, i.e. Clinical Drug Study Sites or authorized hospitals in China. Some medical devices in Classes II and III are excluded from this requirement; they are listed in a “Non Clinical Trial Catalogue”.
Since the end of May 2015 the CFDA has charged the following registration fees.
CFDA has defined very clear requirements, which must be fulfilled by all documents submitted. Applications that fail to comply with these requirements are rejected.
Longer validity of registration
In the future, registrations will be valid for 5 years (previously: 4 years). Manufacturers striving to gain access to China’s lucrative growth market face major challenges, not least of which are language barriers. While the CFDA has an English website with translations of all key regulations, only the original Chinese texts are legally binding. Applications must be submitted in the national language. Documents, registers and lists are only available in Chinese, making the correct classification of medical devices and the search for suitable testing institutes a challenging task. Given this, TÜV SÜD and its team, headed by Qiuyun Zhao, relies on local registration specialists and native speakers who are familiar with the Chinese registration system and know the relevant contact partners.