Registration Strategy for Imported Medical Devices in China

During the regulatory compliance process, starting from the gap analysis to the final step obtaining registration approval for imported medical device are quite complicated and unclear for the foreign companies. It would be a better idea for the foreign companies to make a clear registration strategy to obtain medical device registration approval prior to access the Chinese medical device market.

What needs to be considered while applying for medical device registration?

What are the risks for a new medical device registered in China under CFDA regulations?
Does your registration strategy identify the most cost-effective way to get your medical device approval?
How to find the China legal agent (CLA) and what does your local agent have to be capable of?
What are the regulations and standards applied to your product and how about the current stage of development?
How to analyze the dynamics of registering your medical device in China?
How to define your product in China? Is it a medical device?
How to classify your medical device product in China?
How to conduct a gap analysis for your product?
How to prepare and manage regulatory documentation?
Are the local tests required for CFDA registration?
Whether local clinical trials are needed for registration or not?
Whether the foreign clinical data can be used for CFDA registration or not?
What is the procedure of submission and registration approval?
What is the cost breakdown and duration for a foreign medical device registration in China?

Case study --------Registration Strategy Project
Foreign company A intends to sale their home use medical device in China and they do not have subsidiary office in China.
How to develop the registration strategy for this project?
a) Analyze the general regulatory requirements and risks under CFDA medical device regulations
b) Confirm the classification for the home used medical device
c) Conduct the gap analysis according to the applicable regulations and standards.
d) Compile the registration program
e) Prepare the registration dossiers and submission
f) Find a local partner or establish a local subsidiary to deal with the regulatory problem during the submission and approval.

The medical device registration strategy is different from business strategy. A clear registration strategy is an important step to ensure the medical device CFDA approval successfully with lower cost.
If you would like get the registration strategy report for your medical product, please contact us via md@cirs-group.com, or join our “China Medical Device Regulatory Assistant Program (MDRAP)”.

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