 | 8.10 | Questions & Answers: Licensing of Medical Device Establishments | V1 | | 29-Dec-2017 | 97 KB | |
 | 8.05 | Classification of Medical Devices and IVDs | V2 | | 01-Aug-2017 | 794 KB | |
 | 8.07 | Medical Device Quality Manual | V2 | | 01-Aug-2017 | 440 KB | |
 | 8.04 | Recall, Adverse Event & Post-Marketing Vigilance Reports of Medical Devices & IVDs | V2 | | 01-Aug-2017 | 754 KB | |
 | 16.03 | Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs | V1 | 1.1 | 20-Sep-2016 | 463 KB | |