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Medical Device Registration Consultant

Medical Device Registration Into Qatar

  • REGULATORY AUTHORITY: Medical devices in Qatar are managed by the Ministry of Economy and Commerce (MEC). Currently medical devices do not require registration, and only an import permit is required.
  • CLASSIFICATION SYSTEM: Medical devices are classified according to EU model into risk-based Classes I, IIa, IIb, III, and IV.
  • AUTHORIZED REPRESENTATIVE: A local authorized representative is required to obtain an import permit.
  • ADDITIONAL INFORMATION: Medical devices must be authorized by one of the founding members of the Global Harmonization Task Force (GHTF) to obtain market access.
  • The Malaysian medical device registration process:

    If your device is approved in one of the recognized reference markets (US, European Union, Australia, Japan or Canada) To better understand follow Below process. Here are the basic steps:

  • Determine your classification. Medical devices are classified as Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (highest risk), similar to the classification scheme used in the European Union. Appoint an in-country Malaysia Authorized Representative to manage your device Registration.
  • Prepare an abridged Technical File including your reference country approval, test reports, Malaysian Essential Principles checklist, Malaysian Declaration of Conformity, QMS Certificate, etc. Use ASEAN Common Submission Dossier Template (CSDT) format technical file.
  • Request a technical review of your documentation by a licensed Conformity Assessment Body (CAB).
  • After satisfactory audit by CAB, the verification Certificate is issued.
  • Submit application with CAB certificate and audit report to MDA.
  • MDA begins review. Application will be returned with 90 days to respond for any additional information requests.
  • Upon satisfactory review, MDA grants the registration.