Device certification - Medical Devices Group

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July 2016

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Medical devices sold in Europe carry the CE Mark. Does anyone have a list of non-EU countries who also require the CE Mark? (e.g. the Saudi regulatory body will accept the mark)
Thanks for your feedback!

source: https://www.linkedin.com/groups/78665/78665-6164116792726867974

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Posted by Joy Griffiths

Asked on July 27, 2016 12:00 am

59 views

	Private answer Robert Poyser I would not say non-EU countries require CE mark, but generally most recognise the CE mark and of course FDA approval when registering the device for their market, some countries like China, you have to go through their device certification process. Middle east has a complex registration process, but does accept CE and FDA. Marked as spam Report spam
	Private answer Robert Poyser Most Non EU countries require some form of the following documentation. -C of C -CE Mark/FDA 510K cert -Manufacturers Authorisation letter (to sell) -Copy of IFU -Copy of labelling -Some type of registration form/document And some inc middle east need the documents legalising/apostilling Marked as spam Report spam
	Private answer Joy Griffiths Thanks for your feedback Robert - much appreciated! Marked as spam Report spam
	Private answer Hello Joy, Mexico requires CE mark for sanitary registration, and also many other certifications such as UL and ISO. FDA approval is needed only if you're registering under NA-FTA. Marked as spam Report spam
	Private answer Bill Paine China has a CCC Marked as spam Report spam
	Private answer i need for pakistan Marked as spam Report spam
	Private answer Robert Poyser For Pakistan, this may be a bit out of date Ministry of Health, Special Education and Social Welfare Pakistan Secretariat Islamabad, Pakistan Tel: (92-51) 9202566 Fax: (92-51) 9205481 Contact: Dr. Farzana Ch., Drug Controller. Marked as spam Report spam
	Private answer Joy Griffiths Thank you for your responses - much appreciated! Marked as spam Report spam
	Private answer Marc Weiser I believe Australia TGA accepts CE for their approvals. Marked as spam Report spam
	Private answer Joy Griffiths Thanks Marc! Marked as spam Report spam
	Private answer In India CE and US FDA approvals are considered as good credentials but not mandatory for home registration Marked as spam Report spam
	Private answer For Australia, TGA accepts CE for Class IIa, Class IIb and Class III not Class I, however in some cases such as Device including medicine and Devices with animal origin , manufacturer will need to obtain TGA Conformity assessment Marked as spam Report spam
	Private answer Joy Griffiths Thanks for the extra feedback! Marked as spam Report spam
	Private answer Peter Saalmann Russia does not accept the CE mark but theC E documents are of big help for the registration Marked as spam Report spam
	Private answer CE is required in Turkey, FDA approval is considered as a plus. Marked as spam Report spam
	Private answer Manuel Saccani For Saudi Regulation it's necessary MDMA Certification (it's accept the EU documents) Marked as spam Report spam
	Private answer Hi joe, Morocco requires CE mark for sanitary registration, and also many other certifications such ISO Marked as spam Report spam
	Private answer Joy Griffiths Wow - thanks everyone for your comments! Really appreciate the feedback from so many different markets! Marked as spam Report spam

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