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Note 2 : Provision of the medical device for purposes of clinical evaluations and/or evalu...

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5.2 Customer focus Top management of the manufacturer shall ensure that customer requireme...

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4.2.3 Control of documents : Documents required by the quality management system shall be ...

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[87A. Registration certificate to sell, stock, exhibit or offer for sale or distribute a m...

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SALE OF MEDICAL DEVICES 87. Provisions for sale of medical devices (1) Subject to the prov...

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84. Validity of registration A registration granted under sub-rule (3) of rule 83 in Form ...

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(g) "body orifice" means any natural opening in a human body including the external surfac...

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3. Definitions In these rules, unless the context otherwise requires, — (a) "academic clin...

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(C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 o...

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