Medical Device Regulatory Requirements in Montenegro
| Regulatory Authority |
Institute for Medicines & Medical Devices of Montenegro |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Law on Medical Devices
| Click Here
|
| Registration Process |
Medical Device Registration
| Click Here
|
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Montenegrin Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
The technical documentation and declaration of conformity has to be kept for at least five years after placing the medical product on the market. and for implantable medical devices for at least 15 years; |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025