China Medical Device Registration (NMPA)

CMC Medical Devices offers China Medical Device Registration and Approval

We provide Representation services in China, facilitating the entry of your products into the Chinese market and ensuring compliance with local regulations. We ensure compliance with Chinese regulations and facilitate the entry of your medical devices into the Chinese market.

Authorized Representative in China

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CMC Medical Devices Shanghai Co., Ltd. can represent foreign manufacturers without branches in China as your Authorized Representative in China, to assist in completing the registration of imported medical products with the National Medical Products Administration of China and ensuring the corresponding regulatory compliance of the products.

For manufacturers without branches in China and manufacturers in China, CMC can also provide medical product registration services with the authorities and consultation on related regulations.

Select CMC as your NMPA china

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Frequently asked questions about china medical device registration

Is it mandatory to have a China NMPA agent if my company is based outside China?

Yes, any foreign company that wants to sell products regulated by the China NMPA (National Medical Products Administration) in China must appoint a China-based agent.

What does a China NMPA agent do?

The agent serves as the main point of contact between the foreign company and the NMPA. They handle the registration process, submit documents, respond to regulatory inquiries, and help manage any compliance-related issues.

Is the NMPA agent responsible for the quality or safety of my products?

No, the agent is not responsible for the quality or safety of your products. The company remains fully responsible for ensuring that their products comply with Chinese regulations.

Why appoint CMC Medical Devices as your NMPA china?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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