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(f) Undertaking signed stating that the manufacturing site is in compliance with the prov...

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(iv) the person holding registration certificate shall maintain records of tests for evalu...

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22.0 Information required to be submitted for the in vitro diagnostic medical device: (1) ...

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17.0 In use stability: This section should provide information on in use stability studies...

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(2) Our Authorised agent shall, — (a) act as the official representative for obtaining imp...

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DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the audit ...

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(ii) Directors, executives and personnel responsible for carrying out evaluation and verif...

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In vitro diagnostic medical devices for blood grouping or tissue typing (a) Subject to cl...

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87D. Suspension and cancellation of Registration Certificate.— (1) Where the registration ...

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