Suspension, cancellation, etc. of permission (1) If any person to whom permission ha ...

The manufacturer shall ensure that changes to documents are reviewed and approved eit ...

Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out au ...

Maintenance of records.― (1) The manufacturer or, as the case may be, importer shal ...

Whereas the draft of the Medical Devices Rules, 2016 was published, as required under ...

(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and c ...

Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii ...

Provided that, if the registration certificate holder fails to pay the required regis ...