Apakah syarat yang perlu dipenuhi bagi peranti perubatan Akses Khas di Malaysia? | What qualifies a medical device for Special Access Notification in Malaysia?

Peranti perubatan akses khas ertinya peranti perubatan bagi kegunaan pengamal perubatan dalam situasi kecemasan atau dalam keadaan apabila rawatan perubatan konvensional gagal, tidak tersedia atau tidak sesuai;

A medical device qualifies for Special Access Notification in Malaysia if it is intended for use by medical practitioners in emergency situations or when conventional medical treatment has failed, is unavailable, or unsuitable. This is in accordance with the Medical Device (Exemption) Order 2024, which defines a "special access medical device" under these criteria.