Apakah objektif kawal selia peranti perubatan? | What are the objectives of medical device regulation?

Objektif utama bagi kawal selia peranti perubatan di peringkat nasional adalah seperti berikut:

1. Menangani isu kesihatan & keselamatan awam; dan

2. Memudahkan perdagangan & industri peranti perubatan.

Penguatkuasaan bagi aktiviti kawal selia peranti perubatan di Malaysia adalah melalui Akta Peranti Perubatan 2012 [Akta 737_] yang telah berkuatkuasa sepenuhnya pada 30 Jun 2023. Selain peranti perubatan, _Akta 737 turut memperuntukan tanggungjawab serta kewajipan am pengguna peranti perubatan supaya pengguna peranti perubatan menggunakan peranti perubatan yang telah berdaftar dengan selamat dan seperti fungsi yang diniatkan.

The primary objectives of medical device regulation at the national level are as follows:

1. Addressing public health and safety issues; and

2. Facilitating ease of doing business in trade and the medical device industry.

Enforcement of medical device regulatory activities in Malaysia is governed by the Medical Device Act 2012 [_Act 737_], which came into full force on 30 June 2023. In addition to medical devices, Act 737 also stipulates the general responsibilities and obligations of medical device users to ensure they use registered medical devices safely and as intended.