Procedural issues A system shall be established to enable cross-referencing of CRFs a ...

Permission to conduct clinical performance evaluation for new in vitro diagnostic me ...

PRELIMINARY 1. Short title and commencement (1) These rules may be called the Medical ...

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

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

INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed cons ...

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

APPLICATION FOR GRANT OF LICENCE TO MANUFACTURE FOR SALE AND DISTRIBUTION OF CLASS A ...