Apakah perbezaan Surat Pengkelasan Produk & Sijil Pendaftaran Peranti Perubatan? | What is the difference between Product Classification Letter & Medical Device Registration Certificate?

Surat Pengkelasan Produk adalah satu surat rasmi daripada MDA berkenaan status pengkelasan bagi sesuatu produk.

Jika sesuatu produk itu telah dikeluarkan Surat Pengkelasan Produk sebagai peranti perubatan, maka produk tersebut perlu berdaftar dengan pihak MDA untuk mendapatkan Sijil Pendaftaran Peranti Perubatan.

Sijil Pendaftaran Peranti Perubatan adalah satu sijil yang dikeluarkan oleh pihak MDA bagi sesuatu peranti perubatan.

Product Classification Letter is an official letter from MDA regarding the classification status of a product.

If a product has been issued with a Product Classification Letter as a medical device, then the product needs to be registered with the MDA to obtain a Medical Device Registration Certificate.

Medical Device Registration Certificate is a certificate issued by MDA for a medical device.