Apakah keperluan pelabelan peranti perubatan yang perlu establismen lakukan bagi meletakkan peranti dalam pasaran? | What labeling requirements must establishments comply with to place medical devices on the market?

Establismen perlu mematuhi keperluan pelabelan peranti perubatan seperti dalam Jadual Keenam Peraturan Peranti Perubatan 2012. Sebagai contoh, label perlu meletakkan no. pendaftaran peranti perubatan, maklumat pembuat dan wakil diberi kuasa (nama, alamat, butiran yang boleh dihubungi) dan arahan penggunaan.

Establishments must comply with the labeling requirements for medical devices as outlined in Schedule Six of the Medical Device Regulations 2012. For example, labels must include the medical device registration number, manufacturer and authorized representative information (name, address, contact details), and instructions for use.