Moldova Medical Device Registration

Navigating Medical Device Regulations in Moldova: Insights from the Medicines and Medical Devices Agency (AMDM)

Regulatory Authority

Medicines and Medical Device Agency (AMDM)

The Medicines and Medical Devices Agency (AMDM) is an administrative authority, empowered with regulatory and supervisory powers in the field of medicine, pharmaceutical activity and medical devices.

AMDM has the status of a legal entity under public law, it has a stamp with the State Coat of Arms of the Republic of Moldova, its own balance sheet, treasury accounts, financial and material means, and other attributes in dispensable for the good functionality of the institution.

AMDM carries out its activity in accordance with the Constitution of the Republic of Moldova, the laws and decisions of the Parliament, the decrees of the President of the Republic of Moldova, the ordinances, decisions and provisions of the Government, with the international treaties to which the Republic of Moldova is a party, being subordinate to the Government of The Republic of Moldova.

Link for Regulatory Authority

https://amdm.gov.md/en

Local Regulation for Moldova Medical Device Registration

EUMDR 2017/745

Classification of Medical Devices

• Class I
• Class IIa
• Class IIb
• Class III
• Class IV

Listing or Registration Requirements

1. Medical Device with CE marking – By Notification

The device without the national SM conformity marking shall follow the following steps:

• Appoint Authorized Representative
  
• Carry out registration of the medical device by notification to the Medicines and Medical Device Agency.
• Ensure compliance to all requirements of the Regulations.

2. Medical Device without a CE marking – By National Conformity Assessment and Registration

• Such device will be subjected to conformity assessment route in compliance to regulatory requirements of Moldova.
• Data on registered medical devices should be entered in State Register of Medical Devices.
• For Class I – compile Technical File and issue Declaration of Conformity
• For other Classes – submit application form and technical documents to designated conformity assessment and obtain certificate of conformity.
• Perform registration of medical device by notification to the Medicines and Medical Devices Agency.
• Place the national SM conformity mark.

Documents Required for Moldova Medical Device Registration

• • Technical File
  • QMS certificate
  • Labelling and IFUs

License Validity

5 years

Package Labelling Requirements

The product labeling information may be presented using international symbols. However, for medical devices intended for use in the Republic of Moldova, the labeling, including the user manual, must be provided in Romanian. In the case of medical devices featuring international symbols on their labels, the following details should be included in Romanian:

1. Manufacturer’s name or brand name, along with the name and address of the authorized representative in the Republic of Moldova.

2. The medical device’s name, essential data for identification, and package contents.

3. For devices made to order, the label should state: “dispozitiv fabricat la comandă” (device made to order).

4. If the device is designated for clinical studies, the label should indicate: “exclusiv pentru investigaţii clinice” (exclusive for clinical investigations).

5. Any specific storage and/or handling conditions.

6. Special operational instructions, if applicable.

7. Warnings and/or precautions that need to be observed

Who should make this Communication?

• Manufacturer
• Authorized Representative

Additional Comments

The national conformity mark “SM” (Securitatea conformcerinţeloresenţiale Moldova)indicates that the manufacturer or his Authorized representativeis responsible for placing this mark, has checked the conformity of the products to all main requirements applied in the technical regulations and that the products has been subjected to conformity assessment procedures provided by all applicable technical regulations.

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk