Conditions for registration of medical device testing laboratory The following condit ...

(ii) the applicant shall provide adequate space having regard to the nature and numbe ...

(ii) the applicant shall provide adequate space having regard to the nature and numbe ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

(B) Such summary information may include: (i) declaration or certificate of conformit ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

(f) animal studies that provide direct evidence of safety and performance of the devi ...

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