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(v) "intended use" means the use for which the medical device is intended according t ...

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REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE ...

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The parameters for classification of in vitro diagnostic medical devices as follows: ...

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(b) If the in vitro diagnostic medical device contains any of the following then desc ...

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

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Application for test or evaluation of medical device For the purpose of these rules, ...

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Registration of medical device testing laboratory (1) Before grant of registration to ...

6. However, accelerated approval should be used for a drug that represent significant advances over existing treatment or in case there is an unmet medical need for the indication for which the drug is intended, orphan drug for rare disease etc. in accordance with the provision prescribed under Second Schedule of ND& CT Rules, 2019. 7. ND & CT rules recognize the consideration of surrogate endpoin ...