the permission holder shall inform the date of launch of medical device in the marke ...

(b) If the device contains any of the followings, then descriptive information on th ...

Suspension, cancellation, etc. of permission (1) If any person to whom permission ha ...

Abbreviated terms and definitions A list of abbreviated terms and definitions of spec ...

Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC ME ...

Additional elements, which may be required (a) Statement of foreseeable circumstance ...

(vi) Other in vitro diagnostic medical devices (a) An in vitro diagnostic medical dev ...

Details about the Investigator: (a) Name; (b) Address; (c) Telephone number; (d) Prof ...