Medical Device Act 2012 s 22
s 22 Suspension or revocation of establishment licence
(1) The Authority may suspend or revoke an establishment licence if the licensee—
(a) has contravened any provision of this Act or any regulations made under this Act;
(b) has breached any condition of the licence; or
(c) has been convicted of an offence under this Act or any regulations made under this Act.
(2) If an establishment licence is suspended under subsection (1), the Authority may require the licensee to remedy the contravention or the breach within the period specified by the Authority.
(3) If the Authority is satisfied that the licensee has failed to remedy the contravention or breach as required under subsection (2), or the contravention or breach continues after the establishment licence is suspended under subsection (1), the Authority shall revoke the licence.
Malay text (authoritative)
Penggantungan atau pembatalan lesen establismen
(1) Pihak Berkuasa boleh menggantung atau membatalkan sesuatu lesen establismen jika pemegang lesen—
(a) telah melanggar mana-mana peruntukan Akta ini atau mana-mana peraturan yang dibuat di bawah Akta ini;
(b) telah memungkiri mana-mana syarat lesen; atau
(c) telah disabitkan dengan suatu kesalahan di bawah Akta ini atau mana-mana peraturan yang dibuat di bawah Akta ini.
(2) Jika sesuatu lesen establismen digantung di bawah subseksyen (1), Pihak Berkuasa boleh menghendaki supaya pemegang lesen itu meremedi pelanggaran atau kemungkiran itu dalam tempoh yang ditentukan oleh Pihak Berkuasa.
(3) Jika Pihak Berkuasa berpuas hati bahawa pemegang lesen tidak meremedi pelanggaran atau kemungkiran itu sebagaimana yang dikehendaki di bawah subseksyen (2), atau pelanggaran atau kemungkiran itu masih berterusan selepas lesen establismen itu digantung di bawah subseksyen (1), Pihak Berkuasa hendaklah membatalkan lesen itu.
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).
