Both Montenegro and Albania are not members of the European Union. However, they heavily align their medical device regulations with the **European Union Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) as part of their path toward European integration. The systems are national, and approvals in one country are not automatically valid in the other.

Montenegro Medical Device Registration

1. Regulatory Authority

• Ministry of Health (Ministarstvo zdravlja)
• Pharmaceutical Administration (Direkcija za lijekove) is the operational body.
• Medical Devices Department: The specific unit handling registrations.

2. Regulatory Framework

Based on the former EU Medical Device Directives (AIMDD, MDD, IVDD) but transitioning towards the EU MDR/IVDR.
Key national law: Law on Medical Devices (Official Gazette of Montenegro).

3. Classification & Process

Devices are classified per EU rules (Class I, IIa, IIb, III). The process is **national** and requires a local authorized representative.

General Registration Process:

  a. Appoint a Local Authorized Representative (AR): A legal entity in Montenegro is mandatory for non-resident manufacturers.
    b. Prepare Documentation: Technical documentation, EU Declaration of Conformity, labeling (in Montenegrin), instructions for use (IFU), proof of CE marking (from an EU-recognized Notified Body certificate if applicable for the class), and a Free Sale Certificate from the country of origin.
    c. Submission & Review: The AR submits the application and documentation to the Pharmaceutical Administration.
    d. Decision & Registration: Upon successful review, the authority issues a decision and enters the device in the **National Medical Device Registry**. A registration number is issued.
    e. Post-Market Surveillance (PMS): The manufacturer and AR are responsible for vigilance reporting and PMS activities.

Key Points for Montenegro

• Language: All labeling and IFU must be in the Montenegrin (Serbian, Croatian, Bosnian) language.
• Validity: Registration certificates are typically valid for an **unlimited period**, but changes to the device or its certification require notification/update.
• Fees: Government fees apply for registration and maintenance.

Albania Medical Device Registration

1. Regulatory Authority

• Ministry of Health and Social Protection (Ministria e Shëndetësisë dhe Mbrojtjes Sociale)**
• National Agency of Medicines and Medical Devices (AKBM)** – The main executive agency for registration and control.

2. Regulatory Framework

• Law No. 15/2016 “On Medical Devices”** and subsequent bylaws. The framework is closely modeled on the EU MDD/IVDD, with ongoing updates to align with MDR/IVDR.
• AKBM maintains the **Medical Devices Register**.

3. Classification & Process

• Devices are classified per EU rules (Class I, IIa, IIb, III).
• The process is **national** and requires a local authorized representative.

General Registration Process

• Appoint a Local Authorized Representative (AR): Mandatory for foreign manufacturers. The AR must be a legal entity in Albania.
• Prepare Documentation: Similar to Montenegro: Technical File, Declaration of Conformity, CE Certificate (if applicable), Free Sale Certificate, labeling and IFU in **Albanian**.
• Electronic Submission: Applications are submitted via the **AKBM’s online portal**.
• Assessment & Decision: AKBM reviews the application. For higher-class devices, a more detailed assessment is conducted. Upon approval, the device is entered into the national register.
• Issuance of Certificate: A registration certificate is issued, which has a **validity period** (commonly 5 years, subject to change—always verify).
• Post-Market Obligations: Vigilance reporting and PMS are required through the local AR.

Key Points for Albania

• Language: All labeling and IFU must be in the **Albanian language**.
• Validity & Renewal: Registration certificates have an expiry date and require a **renewal process** before expiration.
• E-System: AKBM utilizes an electronic submission and management system, which is becoming more streamlined.
• Fees: Official government fees are applicable for application, assessment, and renewal.

Comparison & Summary Table

Critical Steps & Recommendations for Market Entry

1. Engage a Local Expert: The single most important step. Appoint a **competent Local Authorized Representative (AR) with proven regulatory experience in the specific country. They will handle communications with authorities, submissions, and ongoing compliance.
2. Ensure EU Compliance First: Since both systems are based on EU regulations, having a valid **CE Marking under the EU MDR/IVDR (or MDD/IVDD during transition) is the foundational requirement. Your technical documentation must be in order.
3. Plan for Translation: Budget and time for professional translation of labeling and Instructions for Use (IFU) into the official local language. This is a non-negotiable requirement.
4. Prepare Country-Specific Dossiers: While based on your EU technical file, the submission dossier for each country may have specific administrative forms and requirements (e.g., Power of Attorney for the AR, Free Sale Certificates).
5. Factor in Timelines and Costs: The entire process from AR appointment to registration can take several months. Account for government fees, AR service fees, and translation costs.
6.  Monitor for Regulatory Changes: Both countries are actively working to align with the EU MDR. Stay informed through your local AR about any changes in procedure or documentation requirements.

Disclaimer: This information is for guidance purposes only. Regulations are subject to change. Always consult with your local authorized representative or legal regulatory experts for the most current and project-specific advice before initiating registration in Montenegro or Albania.