Bolehkah Badan Penilaian Pematuhan (CAB) memberikan penilaian awal kepada pengilang, wakil yang diberi kuasa, pengimport, atau pengedar sebelum pensijilan formal? | Can Conformity Assessment Bodies (CABs) provide manufacturers, authorized representatives, importers, or distributors with a preliminary assessment of their medical device before formal certification?
Tidak. CAB tidak sepatutnya menawarkan perkhidmatan pra-penilaian atau perundingan untuk membantu pengilang, wakil yang diberi kuasa, pengimport, atau pengedar memahami potensi jurang dan keperluan untuk pematuhan sebelum proses penilaian formal bermula.
No. CABs should not offer pre-assessment or consulting services to help manufacturers, authorized representatives, importers, or distributors understand the potential gaps and requirements for compliance before the formal assessment process begins.