To bring medical device product to China has multiple ways depending on your business objectives in addition to the 1) and 2) you mentioned here. I will focus on your 1) and 2) here. Based on your 1) and 2), it seems that you are trying to decide 1) whether to register your device as an imported device (made outside of China) with your own brand name (your own company as the market authorization/license holder) or 2) as a domestic China made product with your own brand name (you are still the market authorization/license holder, if not, things could be different) made by a China local contract manufacturer. We have helped our clients with both 1) and 2). 1) for overseas imported devices, there is a straight forward well-established China registration requirements that needs both technical (local type testing, other documents from MAH, COO approval) and clinical documents (if the product is in clinical exempt list: no need for CER; if not: predicate based or none-predicate based CER/CT). For 1) you must have a China entity as your legal agent (your own in-China office or appointing our China office as your local agent if you do not want to set up your own local office). For 2) as a domestic made product with your own brand, in addition to the registration process mentioned in 1), you will need to set up MAH in China and establish new documentation and process on top of 1) the typical import device registration process. In 2), if your device is class II according to China classification, you do NOT go to national MPA, you go to your MAH location's provincial MPA. 2) typically takes longer unless you are under the special national priority area.
If you are trying to utilize 2) for the benefit of Made-In-China (MIC) policy for the benefit of public hospitals tenders, please bear in mind that NOT all devices will be a good fit for this MIC especially if this is your 1st time entry to China and your device is a niche product. MIC for public hospitals tenders are required when all things are similar and especially in volume based high consumable products purchasing, public hospitals are required to purchase MIC products over imported overseas made products. In the past year or so, MIC has gaining more and more emphasize from public hospitals due to government pressure.
One of the key benefits of MIC is if you want to access the China market earlier without waiting for your country of origin (COO) approval or want to attract more local investment, you can do parallel launch between your COO and China.
Without knowing the products and contexts, I simplified and pros and cons. You are welcome to give me a call if you need further understanding.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------
Original Message:
Sent: 11-May-2023 17:39
From: Anonymous Member
Subject: How to bring medical device product to China
This message was posted by a user wishing to remain anonymous
Hi everyone, we are considering 2 pathways to bring a Class II medical device to China:
1) register as an importer with a CER in the application; once we obtain the approval, we directly ship the product to China
2) find a China-based legal rep and a China-based legal address for the NMPA application; find suppliers and contract manufacturers in China and manufacture the product in China for the China market only.
Can anyone provide some pros and cons analysis of each approach?
Has anyone successfully made the 2nd approach?
Also, what are the requirements for the CER? Can we actually use a CER to replace conducting a clinical trial in China? What are the requirements to do that?
Any feedback is greatly appreciated!
Thanks!