Article Five. Accessories of medical devices shall, for the purpose of this Interim Regulation, be treated as if they are medical devices in their own right and shall comply with all relevant provisions of the Interim Regulation. To obtain marketing authorisation, medical devices shall comply with the relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA, and additionally with provisions specific to the KSA concerning labeling and conditions of supply and/or use.
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Sources: Guidance for Medical Device Authorized Representatives, Guidance for Medical Device Authorized Representatives