Berapa kerap pengilang peranti perubatan, wakil yang sah, pengimport, dan pengedar perlu berurusan dengan Badan Penilaian Pematuhan (CAB)? | How often are medical device manufacturers, authorized representatives, importers, and distributor required to engage with Conformity Assessment Bodies (CABs)?

Kekerapan berurusan dengan CAB bergantung kepada faktor seperti jenis peranti perubatan, klasifikasi risikonya, dan perubahan peraturan. Pengilang, wakil yang sah, pengimport, dan pengedar mungkin perlu berurusan dengan CAB semasa penilaian awal, untuk pematuhan berterusan, dan untuk penilaian semula.

The frequency of engagement with CABs depends on factors such as the type of medical device, its risk classification, and regulatory changes. Manufacturers, authorized representatives, importers, and distributor may need to engage with CABs during initial assessment, for ongoing compliance, and for recertification.