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

2. Applicability: The provisions of this Schedule shall be applicable to manufacturer ...

(v) "intended use" means the use for which the medical device is intended according t ...

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

PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR ...

2. Applicability: The provisions of this Schedule shall be applicable to manufacturer ...

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

7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in dire ...