Adakah komponen peranti perubatan perlu menjalani penilaian pematuhan yang dijalankan oleh Badan Penilaian Pematuhan (CAB) mengikut Akta 737? | Does ancillary medical device component have to undergo conformity assessment conducted by Conformity Assessment Body (CAB) in accordance to Act 737?

Komponen peranti perubatan untuk produk kombinasi ubat-peranti perubatan tidak perlu menjalani penilaian pematuhan yang dijalankan oleh CAB. Produk kombinasi ubat-peranti perubatan ini dikawal selia sebagai ubat oleh pihak berkuasa kawalan ubat mengikut keperluan yang tertera dalam Control of Drugs and Cosmetics Regulations 1984 yang dikeluarkan di bawah Sale of Drug Act 1952 dan mana-mana dokumen berkaitan yang diterbitkan oleh National Pharmaceutical Regulatiory Agency (NPRA). Sila rujuk Appendix 5: Endorsement Letter Application Flow Chart.

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BAHAGIAN KAWALAN PRA PASARAN (BKPP)
03 - 8230 0376

Ancillary medical devices component for a drug-medical device combination product is not subjected to undergone conformity assessment conducted by CAB. This drug-medical device combination product is regulated as drug by drug control authority as in accordance with the requirements set forth in the Control of Drugs and Cosmetics Regulations 1984 which is promulgated under Sale of Drug Act 1952 and any other relevant documents published by National Pharmaceutical Regulatiory Agency (NPRA). Please refer to Appendix 5: Endorsement Letter Application Flow Chart for Ancillary Medical Device Component.

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PRE-MARKET CONTROL DIVISION (BKPP)
03 - 8230 0376