| 16.03 | Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs | V1.1 | 20-Sep-2016 | 463 KB | |
| 8.02 | Medical Devices and IVDs Essential Principles of Safety & Performance showing changes | V1 | 26-Jul-2016 | 966 KB | |
| 8.02 | Medical device IVD essential principles – for comment | V1 | 02-Sep-2014 | 713 KB | |
| 8.04 | Recall, Adverse Event & Post-Marketing Vigilance Reports of Medical Devices & IVDs | V2 | 01-Aug-2017 | 754 KB | |
| 8.05 | Classification of Medical Devices and IVDs | V2 | 01-Aug-2017 | 794 KB | |