Dear Stacy
A China legal agent (also known as NMPA Legal Agent) is appointed per NMPA certificate ie for each product registration. A manufacturer can appoint one China legal agent for one certificate. Therefore if each product is registered under a separate certificate, they can each have a different legal agent.
There is no clear paragraph to specify this, but you can refer to the general requirement for legal agents in Article 14 of the Provision for Medical Device Registration which is available on the English section of the NMPA website here: http://english.nmpa.gov.cn/2019-07/25/c_390617.htm.
Others may have further to add or clarify.
Regards
Hamish
hamish.king@cisema.com------------------------------
Hamish King
Director Business Development
Hong Kong
------------------------------
Original Message:
Sent: 04-Nov-2020 07:49
From: Stacy Novak
Subject: China Legal Agent
With multiple product lines, can a manufacturer appoint more than one China legal agent. If yes, can you point me to the regulations?
Thank you
------------------------------
Stacy Novak
Alachua FL
United States
------------------------------