Adakah Badan Penilaian Pematuhan (CAB) satu-satunya entiti yang bertanggungjawab untuk penilaian dan pensijilan peranti perubatan? | Are Conformity Assessment Bodies (CABs) the only entities responsible for assessment and certification of medical devices?

Tidak, walaupun CAB memainkan peranan penting dalam penilaian pematuhan, pengilang peranti perubatan Kelas A juga mempunyai pilihan untuk mengisytiharkan sendiri pematuhan peranti perubatan mereka. Walau bagaimanapun, peranti perubatan Kelas B, C, dan D memerlukan penilaian oleh CAB.

No, while CABs play a crucial role in conformity assessment, manufacturers of Class A medical devices also have the option to self-declare the conformity of their medical devices. However, classes of B, C, and D medical devices require assessment by a CAB.