Moldova
- Regulatory Authority:
Agency for Medicinal Products and Medical Devices of the Republic of Moldova
- Certificate validity period:
5 years
- Language of labeling and documentation:
Romanian
- Registration period:
45 days
Class I devices
90 days
Class IIa, IIb, III, IV devices
- Medical devices are subject to mandatory registration before being placed on the local market, which is carried out as follows:
CE marked devices: by notification
NOT CE marked: through national conformity assessment and registration
- Authorized Representative:
country resident
- Legislations:
Law of the Republic of Moldova dated 25 May 1993, No.1456-XII “On pharmaceutical activity”
Law of the Republic of Moldova dated 17 December 1997, No.1409-XIII “On medicines”
Order of the Ministry of Health of the Republic of Moldova dated 13 May 2012, No.739 “On authorization of medicinal products for human use and approval of post-marketing changes”
Decision dated 11 July 2018, No.705 “On approval of the Regulation on the conditions of placing on the market of medical devices”
Order dated 12 May 2012, No.358 “On Approval of the Regulations on the Conduct of Pharmacovigilance Activities”
Registration of medical devices in Moldova:
- Medical devices authorized for placing on the EU market (CE-marked) are subject to a simplified procedure for market admission by way of notification
- Medical devices previously NOT placed on the EU market must undergo a conformity assessment procedure in accordance with Moldovan legislation, after which they are entered into the State Register of Medical Devices
It is necessary to: