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.
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.
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.
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.