Medical Device Regulatory Requirements in Moldova
| Regulatory Authority |
Medicine and Medical device agency |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Devices Regulation
About Medical Device
| Click Here
|
| Registration Process |
Chapter 3 of About Medical Device
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it is 3 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in the Moldavian Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
Registration is valid for 5 years from the date of registration in the State Register of Medical Devices. |
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 We are not responsible for errors, omissions, or outdated content.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