REGULATION OF MEDICAL DEVICE 4. Classification of medical devices (1) Medical devices ...

REGISTRATION OF CERTAIN MEDICAL DEVICES 19A. (1) This Chapter shall be applicable to ...

Procedure for disposal of confiscated medical device (1) The Court may refer the conf ...

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

3.6 Component means any raw material, substance, piece, part, software, firmware, lab ...

(b) a pivotal clinical investigation on an investigational medical device shall be ma ...

3.8 Design output means the results of a design effort at each design phase and at th ...

6.0 Resource management 6.1 Provision of resources The manufacturing organization sha ...