PARAMETERS FOR CLASSIFICATION FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. Basic princi ...

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

Sponsor or manufacturer Name and address of the sponsor or manufacturer of the inves ...

"specimen receptacle" means a device, whether vacuum type or not, specifically inten ...

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

Personnel: (i) organisation chart showing the arrangements for key personnel; (ii) qu ...

3. Premises and Facilities: (i) layout of premises with indication of scale; (ii) nat ...

Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the r ...