Apakah dokumen yang diperlukan untuk memohon Sijil Eksport (EC)? | What documents are required to apply for a export certificate (EC)?

Dokumen yang perlu dikemukakan bagi permohonan sijil eksport adalah seperti berikut:

  1. Borang permohonan sijil eksport (klik pautan ini untuk muat turun borang: https://portal.mda.gov.my/images/export/3._EXPORT_CERTIFICATE_FORM.doc)
  2. Surat pengecualian peranti perubatan untuk eksport sahaja dari MDA
  3. Senarai peranti perubatan (klik pautan ini untuk muat turun borang: https://portal.mda.gov.my/images/export/4._MEDICAL_DEVICE_LIST_ECv1.1.docx)
  4. Label peranti perubatan
  5. Surat pengesahan ((klik pautan ini untuk memuat turun borang: https://portal.mda.gov.my/images/export/5._ATTESTATION_TEMPLATEv1.docx))

Untuk maklumat lanjut, kunjungi laman web MDA melalui https://portal.mda.gov.my/index.php/industry/export-certificate

Untuk pertanyaan lanjut, sila hubungi 
BAHAGIAN HUBUNGAN ANTARABANGSA & INDUSTRI (BHAI)
03 - 8230 0208/0209/0395

The documents required for the Export Certificate (EC) application are as follows:

  1. Export certificate application form (click this link to download the form: https://portal.mda.gov.my/images/export/3._EXPORT_CERTIFICATE_FORM.doc)
  2. Export Only Medical Device Exemption Letter issued by MDA
  3. Medical device list (click this link to download the form: https://portal.mda.gov.my/images/export/4._MEDICAL_DEVICE_LIST_ECv1.1.docx)
  4. Medical device label (shall be provided based on importing country information as stated in the application form)
  5. Attestation (click this link to download the form: https://portal.mda.gov.my/images/export/5._ATTESTATION_TEMPLATEv1.docx))

For more information, visit the MDA website via https://portal.mda.gov.my/index.php/industry/export-certificate

For further inquiries, please contact
INTERNATIONAL & INDUSTRY RELATIONS DIVISION (BHAI)
03 - 8230 0208/0209/0395