Mengapa laporan audit ISO 13485 dari Badan yang Dimaklumkan antarabangsa (contohnya, SGS UK) tidak diterima oleh MDA? | Why isn't an ISO 13485 audit report from an international Notified Body (e.g., SGS UK) accepted by the MDA?

Pihak Berkuasa Peranti Perubatan (MDA) memerlukan Badan Penilaian Pematuhan (CAB) berdaftar secara tempatan di Malaysia di bawah Seksyen 10, Akta 737. Ini memastikan CAB memahami peraturan dan piawaian tempatan.

Contoh: Walaupun sesebuah syarikat mempunyai pensijilan ISO 13485 dari badan antarabangsa yang bereputasi, mereka masih perlu menjalani audit oleh CAB berdaftar di Malaysia untuk permohonan lesen establismen mereka.

The Medical Device Authority (MDA) requires that Conformity Assessment Bodies (CABs) be locally registered in Malaysia under Section 10, Act 737. This ensures that the CABs are familiar with local regulations and standards.

Example: Even if a company has ISO 13485 certification from a reputable international body, they would still need to undergo an audit by a Malaysian-registered CAB for their establishment license application.