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FUE Hair Transplant Device



  • Medical Device Committee
    19/02/2014 09:12
    The following question was posed to the committee on this forum on 30th January 2014 at 7.18: "Please help me understand the regulatory requirements for getting an FUE Hairplant machine approved in India, US, Europe" The committee has deliberated on a meaningful response to this and the consolidated answer appears below: It is a very broad and open question which is global in scope so there is no simple answer, without more information. EU Regulations The first question to consider as male pattern hair loss is not, in all cases, a medical condition would be: 'Is this a medical device?' The answer to this may vary across the globe. It would not be a surprise if there were differing positions across the EU. If the device meets the definition of a medical device it will have to comply with the requirements of the Medical Devices Directive 93/42/EEC for the European Union. Our advice would be to engage with an EU Notified Body to discuss whether this is a medical device or not and, if so, what classification. Classification is according to a set of rules (Annex IX of the Medical Devices Directive), and is based on the intended use of the device. We advise that you work with an EU Notified Body (http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.pdf&refe_cd=93%2F42%2FEEC&requesttimeout=900) to agree whether the Medical Devices Directive is applicable, and what classification is appropriate. The key factors to be considered are whether the device is powered (Active Device), or manually operated, whether is disposable or re-useable, and whether it is delivered sterile. The route to CE Marking (if the Medical Devices Directive is applicable) will depend on the classification of the device. US Regulations Regulation in the US will again be based on the details of how the device works. Some devices for harvesting hair follicles require a 510k clearance (e.g. under regulation 21CFR882.4560), however other regulations may apply depending on how the device works. If a 510k is required substantial equivalence with a device already legally on the market in the US will have to be demonstrated. India Assuming that device regulations in India follow applicable WHO regulations then it would be comparable to the responses above. Unfortunately it is not possible to be more definitive without further information.
  • David Morgan
    27/08/2018 12:11
    Best Hair Transplant Center in Istanbul Welcome to the Natural Hair Turkey, https://naturalhairturkey.com/en/best-hair-transplant-center-in-istanbul/ , most visited and liked hair transplantation center of Istanbul and Europe. You can find here Aesthetics operation transactions, dental operations, bariatric surgery and everything about the health and care.
  • The Jollity Box Outlook Care Pvt Ltd
    04/07/2019 13:06
    FUE is the hair restoration technique which is safe , free of scars, no stitches, no pain and gives the patient natural results.With the Help of Advanced Technique of Hair Restoration , Permanent Hair fall can be Reversed.
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