Intellectual Property: CFDA Asks Feedback for Medical Device Master Files Filling Process

CFDA: 12 IVD Standards to be Updated in 2019 – Huge Impact on Renewals and New Registrations
January 25, 2019
Want to Meet with CFDA Reviewers Face to Face with Questions?
January 31, 2019

Intellectual Property: CFDA Asks Feedback for Medical Device Master Files Filling Process

On January 3, 2019, NMPA (CFDA) issued Medical Device Master Files Filing Process (draft) for feedback. Feedbacks need to be submitted by Feb 4, 2019. Medical device master file in China is a technical document submitted 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.

Highlights for the draft Medical Device Master Files Filing Process:

  • The medical device master files are used in the application for registration, renewal, clinical trial approval of medical devices (including IVDs)
  • NMPA will establish a medical device master files registration platform and a database. The owner of the master files shall submit the main document through the registration platform.
  • Authorizing a legal agent is recommended 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 agent.
  • The documents of medical device master files must be signed and translated into Chinese.

ChinaMed Device, LLC is a NMPA certified legal agent. We help you fulfill the pre and post market legal agent requirements, including the master file requirements, without your need to setup office in China. Translation service is provided. For more information on authorized legal agent, email us at info@ChinaMedDevice.com.

Applicants need to submit the technical confidential documents of the third-party enterprises, such as raw material suppliers, to the NMPA to support the registration applications. 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.

 

For the English version of Medical Device Master Files Record Filing Process (Draft), please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

Please click HERE for more information about the legal agent in China

Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in.

 

About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.