Bolehkah peranti perubatan daripada negara tiada hubungan diplomatik dengan Malaysia (Seperti Israel) diimport dan diletakkan dalam pasaran Malaysia? | Can medical devices from countries without diplomatic relations with Malaysia (such as Israel) be imported and placed on the Malaysian market?

MDA tiada halangan memproses pendaftaran peranti perubatan yang diimport daripada negara tiada hubungan diplomatik dengan Malaysia memandangkan peruntukkan undang-undang tersebut adalah bukan di bawah fungsi MDA.

Namun sekiranya peranti tersebut dikenakan sekatan perdagangan oleh pihak Jabatan Kastam Diraja Malaysia, pemohon mesti mendapatkan approved permit (AP) daripada agensi yang berkaitan dan memenuhi kriteria tambahan sebelum mendaftarkan peranti perubatan dengan MDA. Bagi maklumat lanjut boleh merujuk Surat Pekeliling MDA Bil. 1/2024.

MDA has no obstacles in processing the registration of medical devices imported from countries without diplomatic relations with Malaysia since such legal provisions are not within the MDA's functions.

However, if the device is subject to trade restrictions by the Royal Malaysian Customs Department, the applicant must obtain an approved permit (AP) from the relevant agency and meet additional criteria before registering the medical device with the MDA. For further information, refer to MDA Circular Letter No. 1/2024.