Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium
« Back to Previous Page
like 13 comments  share
Sidahmed Tadjer
Manager Regulatory Affairs chez ASPIDE MEDICAL
December 2017
hello, is it possible de continue to sell a medical device in China if the manufacturer stop it in its own country? The product is registered in China.
< 1 min reading time

source: https://www.linkedin.com/groups/78665/78665-6343475714100064259

Marked as spam
Posted by Sidahmed Tadjer
Asked on December 4, 2017 12:00 am
153 views
  • Follow
  • Unfollow
  • Report spam
like 13 comments  share

Meet your next client here. Join our medical devices group community.

Private answer
Could you ask the question a different way, I don't understand what you're asking. Are you saying a product is (a) registered in China but (b) the manufacturer is based elsewhere and discontinues manufacturing? If the question is that straightforward, I would say no, you can't sell what they don't make.
Marked as spam
like
  • Report spam
Private answer
Sidahmed Tadjer Hi Joe, thank you for your aswer. The manufacturer is European. He stopped the european marketing of the product but continue to manufacture it specialy for Chinaese market. the manufacturer want to discontinue the CE marking of the product.
Marked as spam
like
  • Report spam
Private answer
Ames Gross, Arthur Brandwood, what say you?
Marked as spam
like
  • Report spam
Private answer
Sidahmed Tadjer Hi Jo,
I tried to collect advices of different specialists. The information I collected from some of them is that the registration process in China and in Europe are independent.
The registration of medical device in China is requiring a free sell certificate (for this, the product must be CE marked) but when a product is registered in China the manufacturer can sell it until the end of the registration license whether the CE marking is steel available or not.
The problem I have with this logic is that when the manufacturer registers the product, a technical file is communicated to Chinese authority with the CE certificate of the product and FSC. If the manufacturer stops the CE marking, the technical file is not the same. I don’t know if this change (stopping CE marking) is considered as substantial for the CFDA or not. And also, if this change question the validity of the license.
Sorry if I am not clear.
Regards
Marked as spam
like
  • Report spam
Private answer
THX...I agree with Sidahmed....if the product is no longer made in the US or EU and sold in China....the FSC and country of origin requirements are different than when the product was initially registered in China, so once the inventory in China is exhausted, no more products can be sold in China theoretically....however, if the customs officer isn't told about these changes, they still may let some products into China, using the old approvals,etc. However, this is not a good way to do business...thx,ames
Marked as spam
like
  • Report spam
Private answer
Arthur Brandwood The practicalities of the CFDA process are that once in phase the registration grenadine valid irrespective of International changes. So all is well... until renewal comes around 5 years later.

Separately, CFDA have just proposed *removing * country of origin approval requirements for designated Innovative Devices. The notion is to open a pathway for new technologies to go to China first. See http://brandwoodbiomedical.com/streamlined-cfda-review-process-new-opportunities-in-china/
Marked as spam
like
  • Report spam
Private answer
Diana Downs If it is not CE it cannot be sold
Marked as spam
like
  • Report spam
Private answer
Yes, this happens all the time. Going back to the early 1970’s when a US Nutritional company had a baby formula that did not meet adequate standards and was removed from US market, it continued to be sold in other countries. Blood glucose monitors , for people with diabetes, may have a different name than the US version or even not be available in US market. Same for insulin pumps and I am sure many other medical devices. I would caution that such equipment may in fact be “Fraudulant”. In that such devices are not truly manufactured by the company but are actual copy cats. If any medical device is not being sold directly by the manufacturer or an agent of the manufacturer
I would be concerned about legitimacy.
Marked as spam
like
  • Report spam
Private answer
Diana Downs I'm not sure what you mean by this. Had the company been required to stop manufacturing? Has there been a recall or market pull?
Marked as spam
like
  • Report spam
Private answer
Logically,no
Marked as spam
like
  • Report spam
Private answer
Dave Sheppard, CMAA The easiest way would be to find a good China partner and I'm sure multiple solutions can be achieved.
Marked as spam
like
  • Report spam
Private answer
If China government wants to inspect your company, how to deal with it?
Marked as spam
like
  • Report spam
Private answer
Cornelio Florian But if you know of any risk or possible harm to your customers, you should stop immediately distributing this specific device on your own.
Marked as spam
like
  • Report spam
« Back to Previous Page
Ask a Question
Leave a Comment

We still use LinkedIn to access our site because it’s the only way to “pull in” your LinkedIn photo, name, and hyperlink to your profile page, all vital in building your professional network. When you log in using LinkedIn, you are giving LinkedIn your password, not me. I never see nor store your LinkedIn credentials.

Stay connected with us.

By signing up you are agreeing to our Privacy Policy.

Categories

  • Capital/Investment
    • Business Model
    • Funding
  • Careers
  • Design/Devel
    • Design
    • Development
    • Human Factors
    • Labeling
    • Material Selection
    • R&D
    • Trials and Post-Market
  • Featured
  • Industry
    • Announcements
    • Device Tax
    • Hospital and Health Care
    • Innovation
    • Medtech
  • LinkedIn, etc.
  • Markets
    • Africa
    • Americas
    • Asia
    • Australia
    • Europe
  • Regulating
    • CE Marking
    • EU
    • FDA
    • FDA/EU etc.
    • Notified Bodies
    • Quality
    • Regulatory
  • Selling
    • Distribution
    • Intellectual Property
    • Marketing/Sales
    • Reimbursement
  • Worth bookmarking!
Feature your job here.
logo

Companion to LinkedIn's 350,000 member community

  • Contact
  • Medical Device Marketing
  • In Memoriam
  • Medical Device Conference

The Medical Devices Group   |   Copyright © 2025 Terms, Conditions & Privacy

Medical Devices Group
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.