Dear All,
Grace is absolutely right regarding the observed deficiencies of some NMPA Legal Agents.
You should be really alerted, because of two points:
- If your answer to the "Supplementary Notice" fails, your application is more or less gone, so please double-check with experienced Regulatory Professionals
- Representation at NMPA as Legal Agent is a very important role with increased responsibilities especially in Post Market Suveillance (PMS). As distributors tend to look only forward to Sales, they often forget to look back …
Therefore I strongly underline Grace´s recommendation to consult specialised Regulatory Professionals. Please feel free to e-mail me at roepke@cisema.de
Best regards,
Markus
------------------------------
Markus Roepke
Business Development D/A/CH
Regulatory Affairs in P.R. China
Cisema GmbH
Munich Area
Germany
roepke@cisema.de------------------------------
Original Message:
Sent: 07-Jul-2021 13:09
From: Grace Fu Palma
Subject: Device Registration China - Aging / Shelf Life Studies
It sounds like your local distributor does not know the China registration process well. We have helped many western manufacturers to register their devices with China NMPA (CFDA, SFDA, depending on which year) registration. When compared with accelerated testing report, real time testing report is preferred. NMPA usually accepts manufacturers self-test report in real time/accelerated test reports if they meet China standards. With language barrier, sometimes distributors' lack of professional regulatory knowledge of the changing landscape with NMPA in the past few years, I am not surprised to see the issues you are facing. Please feel free to email us at info@ChinaMedDevice.com if you need further assistance.
------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
Original Message:
Sent: 03-Jul-2021 09:45
From: Anonymous Member
Subject: Device Registration China - Aging / Shelf Life Studies
This message was posted by a user wishing to remain anonymous
We're currently in the process of registering our device in China through a local distributor. When the technical documentation was reviewed they cited a deficiency as we only have real time aging studies completed. They are stating we must provide accelerated aging also. This seems crazy to me - I could understand it if we had accelerated and not real time, but is that really a thing?! There has been no explanation provided to us as to why this is needed by the local agent. What justification could there be for refusing an application because real time data was available, but accelerated data wasn't? Grateful for any help or insight with the Chinese regulations.
Many thanks in advance!