MAH and distributor are very different concepts for overseas manufacturers. If you licensed your product tech to your distributor as a domestic product, the distributor could be a MAH. For an overseas manufacturer, if you want to register and sell under your own brand, you are the MAH. You need a local LA to help you register the product. Not all consulting companies can be LA. We are a NMPA (CFDA) certified LA and can help you register as an independent 3rd party. We can be responsible for your submission as well as post market activities. We also have a QA manager as well as test engineer to support further post market and submission local testing at NMPA (CFDA) testing centers.
I have explained the difference between LA and MAH in a different thread. I am giving a talk on the key updates of 2018 and also publishing a Blue Book on the 2018 updates and changes. You can visit our website China Medical Device - Accelerate Your Medical Device's Entry Into China to sign up CFDA news roundup and indicate you are interested in the upcoming webinar. Or email me gpalma@ChinaMedDevice.com
LA and MAH are very different concepts and meant for different targets. Not easy to explain in a few sentences. MAH concept was introduced this year and is being piloted in 3 areas in China for domestic Chinese manufacturers. MAH system is implemented to support China innovation speed to market. For the 1st time, manufacturers and market entities of the product can be separated inside China under the MAH system. LA current decree will be replaced soon with a new LA decree. LA is needed for all imported manufacturers who want to register in China. We are a certified LA who can represent foreign manufacturers to do the registration as independent 3rd party. This way you do not need to set up an entity in China or appoint your distributor as your LA.
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.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------
Original Message:
Sent: 10-Jan-2019 09:53
From: Anonymous Member
Subject: Marketing Authorization Holder
This message was posted by a user wishing to remain anonymous
What is the difference between a Marketing Authorization Holder (MAH) and a distributor? For example, you are a device manufacturer based on North America, and you would like to apply for approval of a medical device in say China. You appoint a distributor to apply for CFDA for a licence on your behalf; does this distributor automatically become a marketing authorization holder, who will be responsible for postmarketing activities in China (e.g. adverse event reporting, corrective actions or recalls)? You appoint a third party consulting company to register on your behalf in a foreign country, does the consultant become a marketing authorization holder? What is the difference between a sponsor and an MAH?
Thanks. I would appreciate any insight.