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MT · S.L. 458.59

Medical Devices And In-Vitro Diagnostic (S.L. 458.59)

Van kracht11 artikelenTekst gecontroleerd op 24.10.2026

Inhoud

  1. Art. 1 Citation.
  2. Art. 2 Interpretation. Cap. 458. Cap. 458. Cap. 465. Cap. 465. 2 [S.L. Cap. 465.
  3. Art. 3 Designation of competent authority and accrediting body.
  4. Art. 4 Administration.
  5. Art. 5 Importation, wholesaling, manufacturing or re-purposing of medicinal devices. 3
  6. Art. 6 Obligation for medicaldevice registeredperson.
  7. Art. 7 Issuing of approval.
  8. Art. 8 Issue of guidelines. 4 [S.L.
  9. Art. 9 Monitoring and review of operations.
  10. Art. 10 Obligation of economic operators to transmit complaints to competent authority.
  11. Art. 11 Fines and penalties.