(1) A person who, prior to the appointed date, has imported, exported or placed in the market medical devices shall, within twenty four months from the appointed date, apply for the registration of the medical devices under section 6.
(2) A person who, prior to the appointed date, has been importing, exporting or placing in the market medical devices and intend to continue importing, exporting or placing in the market such medical devices shall, within twelve months from the appointed date, apply for an establishment licence under section 16.
(3) A person referred to in subsection (1) or (2) may continue to import, export or place in the market the medical devices pending determination of its application for registration of a medical device or for an establishment licence, as the case may be.
LAWS OF MALAYSIA
Malay text (authoritative)
Kecualian dan peralihan
(1) Seseorang yang, sebelum tarikh yang ditetapkan, telah mengimport, mengeksport atau meletakkan dalam pasaran peranti perubatan hendaklah, dalam tempoh dua puluh empat bulan dari tarikh yang ditetapkan, memohon bagi pendaftaran peranti perubatan itu di bawah seksyen 6.
(2) Seseorang yang, sebelum tarikh yang ditetapkan, telah mengimport, mengeksport atau meletakkan dalam pasaran peranti perubatan dan berniat untuk terus mengimport, mengeksport atau meletakkan dalam pasaran peranti perubatan sedemikian hendaklah, dalam tempoh dua belas bulan dari tarikh yang ditetapkan, memohon lesen establismen di bawah seksyen 16.
(3) Seseorang yang disebut dalam subseksyen (1) atau (2) boleh terus mengimport, mengeksport atau meletakkan dalam pasaran peranti perubatan sementara menunggu keputusan permohonannya bagi pendaftaran sesuatu peranti perubatan atau bagi lesen establismen, mengikut mana-mana yang berkenaan
UNDANG-UNDANG MALAYSIA
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).
