China Launches Medical Device Master File System

by Grace Wang Mar 26, 2021

On Mar. 12, 2021, China National Medical Products Administration (NMPA) announced guidance for the voluntary filing of medical device master files (MAFs) with immediate effect. 

The guidance specifies MAF content, format, and filing procedures. 1

RELATED UPDATE: 

Main Content of MAFs

An MAF should include specific technical contents. The current guidance focuses on the raw materials of medical devices. The following information is provided as the example of content requirement for raw materials:

  • Compositions.

  • Research data on physical and chemical properties.

  • Biological evaluation data or toxicological risk analysis, etc.

Application Scope of MAFs

It is applicable to 

  • imported Class 2 and Class 3 medical devices;

  • domestic Class 3 medical devices;

  • imported Class 2 and Class 3 in vitro diagnostic (IVD) reagents;

  • domestic Class 3 IVD reagents.

Rights and Obligations

It is voluntary for parties to submit MAFs to NMPA as the holders. The MAFs shall be substantively reviewed together after the submission of the related medical device's pre-marketing application.

The filed MAFs can be authorized by the MAF holder to the medical device applicants so that the applicants can incorporate the MAF information by reference as part of their registration application materials.

However, medical device applicants are still the ones that assume the responsibility of ensuring the safety and efficacy of final products2, which is very similar to the MAH system for drug products. 

How to File or Amend an MAF

1. Domestic MAF holders can directly submit MAFs by themselves; if an MAF submitter is a foreign company (including those in Hong Kong SAR, Macao SAR, and Taiwan, China), it should retain an agent or representative in China.

2. Application Documentation

For initial MAF filing applications, the holders shall submit the Application Form for Filing Medical Device Master Files. For any changes to an on-file MAF, such as changes in authorization or agent or modification of the product, the holders should submit the Application Form for Amending Medical Device Master Files.

Business documents and technical information shall be provided as attachments for either submitting or amending an MAF.

Overseas holders should submit the following business documents:

  • Notarized business license of the MAF holder company.

  • The power of attorney letter and letter of commitment with the designated local agent, and the copy of business license of the local agent.

3. All the documents for MAF submission should be signed and sealed by their holder. An MAF must be in the Chinese language or be accompanied by accurate English translations of any of the documents that are in a language other than Chinese. The Chinese translations could be signed and sealed by the designated local agent.

4. The application should be submitted through the online eRPS system after the holder or agent gets the Certificate Authority (CA) digital certificates.

The general information of MAF will be published on NMPA's website (confidential information will not be disclosed). 

Benefits of the Medical Device Master File System

Confidential reviews are allowed for NMPA if the MAF holder prefers not to provide their secret product information to the medical device applicant.

In the case that several applications may be submitted for different products which may use a common material or process, it also avoids repetitive submission and simplifies NMPA's review procedure.


Grace Wang
ChemLinked Regulatory Analyst & Editor
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