Bolehkah Badan Penilaian Pematuhan (CAB) beroperasi di peringkat antarabangsa? | Can Conformity Assessment Bodies (CABs) operate internationally?
Ya, sesetengah CAB mungkin mempunyai keupayaan untuk beroperasi di peringkat antarabangsa dan menyediakan perkhidmatan penilaian di luar sempadan Malaysia. Ini amat relevan bagi pengilang yang ingin mengedarkan peranti perubatan mereka di beberapa negara. Walau bagaimanapun, untuk mengedarkan peranti perubatan di pasaran Malaysia, penilaian pematuhan mesti dilakukan oleh Badan Penilaian Pematuhan (CAB) yang berdaftar di bawah Akta 737.
Yes, some CABs may have the capability to operate internationally and provide assessment services beyond Malaysia's borders. This is especially relevant for manufacturers seeking to distribute their medical devices in multiple countries. But to distribute medical devices on the Malaysian market, the conformity assessments must be performed by Conformity Assessment Bodies (CABs) registered under the Act 737.