Apakah keperluan untuk membuat permohonan pengecualian peranti perubatan yang dibuat khas? | What are the regulatory requirements for custom-made medical devices?

Peranti perubatan yang dibuat khas dikecualikan daripada pelesenan establismen dan pendaftaran, tetapi permohonan pengecualian perlu dibuat melalui Sistem Medcast. Untuk maklumat terperinci tentang proses pengecualian dan keperluan khusus, sila rujuk bahagian Custom-Made Medical Device pada Portal MDA.

Pautan : https://portal.mda.gov.my/index.php/industry/exemption/custom-made-medical-device

Untuk pertanyaan lanjut, sila hubungi 
BAHAGIAN KAWALAN PRA PASARAN (BKPP)
03 - 8230 0376

Custom-made medical devices are exempt from establishment licensing and device registration. For detailed information on the exemption process and specific requirements, please refer to the Custom-made Medical Device section on the MDA Portal.

Link : https://portal.mda.gov.my/index.php/industry/exemption/custom-made-medical-device

For further inquiries, please contact
PRE-MARKET CONTROL DIVISION (BKPP)
03 - 8230 0376