The Common Confusion While Applying for Record Keeping (Registration) for Medical Device of Class I - Regulatory News - Medical Devices

Within this year, CIRS has obtained the record certificate for medical device of class I for many Europe manufacturers successfully. During communication with manufacturers, we find the manufacturers always have the common confusions about certificate and notarization. We will help you solve the confusions through the following content.

At first you shall know the record procedure for imported medical devices of Class I in China, please click here to understand the more information.

The confusions about certificate and notarization always arise in the Step 3, Dossier Preparation.

1. License name confusion

The different name of license between Europe and China leads to the manufacturer cannot know which license are required.
Manufacture shall submit the supporting documents as registration certificate for medical device, business license, and production certification in China. What are their name of corresponding certificates in Europe?

中文	In China	In Europe
醫療器械注冊證	Registration for Medical Device	Product Certificate of Registration
企業營業執照	Business License	Company Certificate of Registration
企業生產許可證	Production License	EC Certificate & Declaration of Conformity

2. Notarization confusion

Pursuant to Operation Specification of Registration Approval for Class III Medical Device and Imported Medical Device, the original documents of application for imported medical device shall be sealed and signed by your legal person. And all the documents shall be notarized.
Document notarization is divided into consistency notarization and authenticity notarization.

2.1 Consistency notarization refers to the copies of certificates are consistent with the originals.

2.2 Authenticity notarization refers to refers to the seal and the signature is authentic.

Notarization form	Documents
Consistency notarization	Copy of Registration Certificate Copy of Business License Copy of GMP/ ISO13485/ Production License
Authenticity notarization	Instruction and Label Risk analysis report Technical requirements Clinical evaluation materials Manufacturing information POA of China agent Certificate of Analysis (COA) Declaration of Conformity

The purpose of notarization is to ensure the documents of registration are true, and the action of applicants is their true intentions.

For any more questions on the record keeping for imported medical devices of Class I, please feel free to reach CIRS.

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