Overall synopsis of the clinical investigation A summary or overview of the clinical ...

Overall synopsis of the clinical investigation A summary or overview of the clinical ...

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

2.0 Device description and product specification, including variants and accessories ...

2.0 Device description and product specification, including variants and accessories ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a s ...

REGISTRATION OF CLASS A (NON-STERILE AND NONMEASURING) MEDICAL DEVICES 19G. Applicat ...