UNIT DASAR DAN REGULATORI
- Apakah objektif kawal selia peranti perubatan? | What are the objectives of medical device regulation?
- Apakah Akta Peranti Perubatan 2012 [Akta 737]? | What is the Medical Device Act 2012 [Act 737]?
- Apakah Akta Pihak Berkuasa Peranti Perubatan 2012 [Akta 738]? | What is the Medical Device Authority Act 2012 [Act 738]?
- Adakah semua peranti perubatan perlu didaftarkan dengan MDA? | Do all medical devices need to be registered with the MDA?
- Apakah Perintah Peranti Perubatan (Pengecualian)? | What is the Medical Device (Exemption) Order?
- Apakah tindakan yang boleh diambil oleh MDA jika peranti perubatan didapati tidak mematuhi Akta 737? | What actions can the MDA take if a medical device is found to be non-compliant with Act 737?
- Apakah Peraturan-Peraturan Peranti Perubatan (Pengkompaunan Kesalahan) 2024? | What are the Medical Device (Compounding Offences) Regulations 2024?
- Bolehkah peranti perubatan daripada negara tiada hubungan diplomatik dengan Malaysia (Seperti Israel) diimport dan diletakkan dalam pasaran Malaysia? | Can medical devices from countries without diplomatic relations with Malaysia (such as Israel) be imported and placed on the Malaysian market?