What is China NMPA Registration?
NMPA is the acronym of National Medical Products Administration. NMPA was formerly called the China Food and Drug Administration (CFDA). NMPA falls under the State Administration for Market Regulation (SAMR) as a vice-ministerial level body. NMPA is responsible for governing and supervising the safety and quality of cosmetics, drugs and medical devices in China.
Why is China NMPA Registration Important?
IVD and Medical Device Manufacturers have to get NMPA Approval and complete the registration successfully in order to market their medical devices in the Chinese market.
How Can We Help?
The registration process of NMPA has rigorous regulatory requirements. Especially, if you are a foreign manufacturer, then you have to be extra cautious in meeting the regulations, in order to import your medical device in the Chinese market. Medmonts's expert crew is always there to assist you through the entire process of NMPA Registration and Approval. We can prepare the required documents and indeed register your medical device with China NMPA.
China NMPA Registration process involves the following steps and we are glad to assist you with all these:
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​Classify your device as one among Class I, Class II, or Class III device based on its risk level
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Hire an agent who is residing in China to manage the NMPA registration of your medical device
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Submit documentation for the approval of proof of the home country
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Submit notarized documentation for proof of the manufacturer qualification
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Prepare the document titled Product Technical Requirement
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If your device is classified as Class II or Class III type, then submit your device for testing in China
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Prepare Technical Documentation if your device is classified to be a Class I type. In the case of Class II or Class III device, prepare registration application encompassing Agent Authorization Letter, appropriate Test Reports, and other applicable technical documents. Make sure that the registration application and documents specified earlier are prepared in the Chinese language
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Administrative Review has to be conducted for Class I type. Complete Application Review has to be conducted for Class II and Class III type devices
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Class I device anticipates a voucher from NMPA, which will be published on the website. Class II or Class III device requires Registration Certificate from NMPA, which is valid for 5 year
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Now you are all set to market your device in China!
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This is just an overview. Each step above has a detailed process to be followed, which we can work upon with ease and expertise!