September 15, 2014
The Chinese medical device market is the fourth largest market in the world. The estimated market value was over 17 billion dollars in 2013 and the market is growing fast. Expected growth is 15-20% per year for the next 10 years, and with Chinese manufacturers not able to meet demand, it makes China an attractive market for foreign medical device companies. On 1 June 2014, the newly revised Regulations for the Supervision and Administration of Medical Devices’ (State Council Order No.650) was put into force. To support the implementation of the regulations, the China Food and Drug Administration (CFDA) formulated and revised five important administrative measures. These administrative measures will go into effect on October 1, 2014.
Chinese Regulatory Environment For Medical Devices
Approval from the China Food and Drug Administration (CFDA) is required for medical devices to be put into the Chinese market.
The most important laws and regulations for medical devices are:
Medical Device Classification And Testing
The CFDA has a similar classification for medical devices as the FDA: Class I devices are carried through routine administration, but Class II and III have stricter controls, accordingly. Provisions for classification are given in CFDA’s Order 15 here: http://eng.sfda.gov.cn/WS03/CL0768/61643.html
(NB: To support the new regulations, the updated provisions for classification are in draft format.)
For Class II and III equipment testing, the manufacturer should draft the technical requirements. The requirements are similar to the Essential Requirements Checklist and should:
For active Class II and Class III devices, the CB test reports do not exempt them from testing, but they can be helpful. The devices will be tested according to the technical requirements in a Chinese testing laboratory that is supervised by the CFDA.
The applicable national standards are:
For Class I, the supplied clinical evaluation report will be accepted.
For Class II and Class III device:
(NB: The ‘clinical trial exemption database’ is still in draft format.)
CFDA Application And Registration
The CFDA application and the required documents need to be provided in Chinese and in English. For the application and contacts, a Chinese Registration Agency is required – the manufacturer signs the English versions of documents, and the agency in China signs the Chinese versions.
In addition to the application, several other documents are required:
(NB: To support the new regulations the document list above will be updated – no official notice of changes to date.)
In principle, the CFDA technical review and administrative review need 90 working days if there are no on-hold comments.
In practice, the expected lead-time for a Class II device is typically 9-16 months (e.g. documents preparation, testing, CFDA review).
SGS China can assist in scheduling the registration process, give an action plan for each step, provide guidance for the CFDA application and document preparation, and review the documents, communicate with the testing lab and follow-up the review process to ensure smooth progress. Additionally, SGS can give relevant CFDA registration regulation consultation.
For more information please visit www.sgs.com/consumermedicaldevices
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