Apakah dokumen yang diperlukan untuk memohon surat pengecualian bagi eksport sahaja | What are the documents required for Export Only?

Dokumen yang diperlukan adalah seperti berikut:

  1. Notification of Export Only Medical Device Form
  2. Registrar of Companies (ROC) certificate of applicant
  3. Declaration Traceability of Evidence of Conformity Attestation Template for Export Only Medical Device
  4. Letter of Authorization for OEM/Contract Manufacturer/Authorized Exporter issued by QMS ISO 13485 cert holder
  5. A copy manufacturer’s QMS ISO 13485 certificate
  6. A copy of Brochure/Leaflet/Label/IFU that contain information on brief description and intended use.
  7. 7) A copy of establishment license (If applicable)

Untuk maklumat lanjut sila layari pautan yang disediakan : https://portal.mda.gov.my/index.php/industry/notification-for-export-only-medical-device

The required documents are as follows:

  1. Notification of Export Only Medical Device Form
  2. Registrar of Companies (ROC) certificate of applicant
  3. Declaration Traceability of Evidence of Conformity Attestation Template for Export Only Medical Device
  4. Letter of Authorization for OEM/Contract Manufacturer/Authorized Exporter issued by QMS ISO 13485 cert holder
  5. A copy manufacturer’s QMS ISO 13485 certificate
  6. A copy of Brochure/Leaflet/Label/IFU that contain information on brief description and intended use.
  7. A copy of establishment license (If applicable)

For more information please visit the information provided:https://portal.mda.gov.my/index.php/industry/notification-for-export-only-medical-device