NMPA issued Notice regarding Medical Device Master Files Register on March 12, 2021. The draft was published in January 2019.
Medical device master file in China is a technical document that owner of the file submits to NMPA Center of Medical Device Evaluation (CMDE) to authorize the applicant to use in the medical device registration but does not directly disclose the content to the applicant.
The purpose of the medical device master file is to protect the technical secrets of the documents’ owner and to avoid the repeated submission of the same technical documents by different parties.
Legal representative will play a big role in the master files for overseas device applicants and owners. Authorizing a legal agent is a must for foreign manufacturers to communicate filling process and renew master files in time. The owners of master file shall specify the name, address, contact and authorized authority for the legal representative.
China Med Device, LLC is NMPA certified legal representative. We can help you fulfill the pre and post market legal agent requirements without your need to setup office in China. Translation service is provided. info@ChinaMedDevice.com.
The document states that:
- The registration applicant shall guide and assist the owner of the master file to establish the master file. The applicant shall bear full responsibility for the medical devices they declare.
- It is applicable for imported Class II, Class III and domestic Class III devices and IVDs.
- The CMDE establishes a master document registration platform and a database. The owner of the master document can submit the master document registration information through the registration platform and obtain the master document registration number after registration. The CMDE will review the main documents after the related medical device has filed the relevant application for registration.
- The documents of medical device master files must be signed and translated into Chinese.
For master files-related requirement on digital Certificate Authority in the electronic Regulated Product Submission (eRPS) and the template for master fillers, please email us at info@ChinaMedDevice.com.