Some devices are no longer managed as class I medical devices in China
from CIRSby Edwin
Medical device manufacturer are not required to register for class I medical devices under the new medical device regulations (known as decree No. 650 ), and only required to record in CFDA, and the record keeping effects permanent once it approved by CFDA. It significantly simplifies the administrative approval process and reduces the cost and duration for applicant.
CFDA have modified the classification of class I medical devices and issued the "Catalogue of class I medical devices" on May 30th 2014. Any devices not listed in this catalogue will be considered as non class I medical devices. There are some devices deemed to be no longer managed as class I medical devices in China:
Sterile medical device
Sanitary materials contained disinfectant
Surgical instruments used with the endoscope
Orthopedic surgical instruments directly contacted with intervertebral space when used
Collective packing product contained higher control level medical devices
Foreign devices manufacturer need to understand that you are required to update your registration if the classification of your product changed. If you would like to confirm the new classification of your medical device and how to comply with it, please join CIRS regulatory assistant program (MDRAP).
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