Other information: This section of PSUR shall include details about signals and Risk ...

2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationa ...

Note: 1. All reports submitted as a part of the dossier should be signed and dated by ...

1.8 Domestic price of the device in the currency followed in the country of origin. ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...

Other information: This section of PSUR shall include details about signals and Risk ...

(b) the intended user (lay person or professional); (c) a general description of the ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...