Performance evaluation report from a laboratory designated under subrule (1) of rule ...

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

All relevant clinical and non-clinical safety data will cover only the period of the ...

Improvement General: The manufacturer shall identify and implement any changes necess ...

BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. ...

Definitions In these rules, unless the context otherwise requires, — (a) "academic cl ...

Details of suspected adverse device reaction(s): (a) Full description of reaction(s) ...

Informed consent: (i) In all investigations, a freely given, informed, written consen ...