Medical Device Act 2012 s 7
s 7 Registration and refusal to register medical device
(1) Upon receipt of an application made under section 6 and the Authority being satisfied that—
(a) the medical device has been subjected to the conformity assessment procedures carried out by a conformity assessment body; and
(b) the applicant has complied with any requirement of the Authority made under subsection 6(4),
the Authority may, after such inspection of the premises in which the medical device is being manufactured as it considers proper and necessary to carry out and on payment of the prescribed registration fee, register the medical device for a prescribed period subject to such conditions as the Authority thinks fit to impose, assign a registration number to the medical device and issue to the applicant a certificate of registration.
(2) The Authority shall not register the medical device if it is not satisfied with any matter referred to in subsection (1).
Malay text (authoritative)
Pendaftaran dan keengganan untuk mendaftarkan peranti perubatan
(1) Apabila permohonan yang dibuat di bawah seksyen 6 diterima dan Pihak Berkuasa berpuas hati bahawa—
(a) peranti perubatan itu telah menjalani tatacara penilaian pematuhan yang dijalankan oleh suatu badan penilaian pematuhan; dan
(b) pemohon telah mematuhi apa-apa kehendak Pihak Berkuasa yang dibuat di bawah subseksyen 6(4),
Pihak Berkuasa boleh, selepas apa-apa pemeriksaan premis yang di dalamnya peranti perubatan itu dibuat sebagaimana yang difikirkannya patut dan perlu untuk dijalankan dan apabila fi pendaftaran yang ditetapkan dibayar, mendaftarkan peranti perubatan itu bagi suatu tempoh yang ditetapkan tertakluk kepada apa-apa syarat yang difikirkan patut oleh Pihak Berkuasa untuk dikenakan, memberikan suatu nombor pendaftaran kepada peranti perubatan itu dan mengeluarkan suatu perakuan pendaftaran kepada pemohon.
(2) Pihak Berkuasa tidak boleh mendaftarkan peranti perubatan itu jika ia tidak berpuas hati dengan apa-apa perkara yang disebut dalam subseksyen (1).
Read this section in the full act → · Open Chapter 1 →
Find Act 737 on lom.agc.gov.my ↗
Text as at 1 March 2017 (LOM reprint); amendments made after that date may not be incorporated.
Source: Laws of Malaysia, Attorney General's Chambers of Malaysia (lom.agc.gov.my). Not a copy of the Gazette printed by the Government Printer (Interpretation Acts 1948 and 1967, s 61).
