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:
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.
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.