Monitoring plan General outline of the monitoring plan to be followed, including acce ...

Notes: Central Drugs Standard Control Organization, Ministry of Health and Family Wel ...

Particular requirement for active implantable medical devices and implantable medica ...

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

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

The manufacturer shall ensure that non-conforming product is accepted by concession o ...

3.0 Labelling: The dossier should typically contain a complete set of labeling associ ...

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