PENGUMUMAN

 

Pelaksanaan Peraturan-Peraturan (Pengiklanan) Peranti Perubatan 2019

Susulan daripada pewartaan Peraturan-Peraturan (Pengiklanan) Peranti Perubatan 2019, dan pengumuman mengenai pelaksanaan Peraturan-Peraturan ini, Pihak Berkuasa Peranti Perubatan (MDA) ingin memaklumkan pelaksanaan kawalan iklan telah mula dilaksanakan pada 4 Mei 2021. Mulai daripada tarikh tersebut, mana-mana establismen, agensi pengiklanan atau mana-mana orang yang hendak mengiklankan mana-mana peranti perubatan berdaftar boleh mula membuat permohonan kelulusan iklan dari MDA.

Dengan pewartaan Peraturan-Peraturan ini, mana-mana iklan peranti perubatan hendaklah memenuhi keperluan-keperluan yang dinyatakan dalam seksyen 44 Akta Peranti Perubatan (Akta 737) dan Peraturan-Peraturan (Pengiklanan) Peranti Perubatan 2019. Bagi memberi panduan kepada mana-mana establismen, agensi pengiklanan atau mana-mana orang yang hendak mengiklankan mana-mana peranti perubatan berdaftar, MDA telah menyediakan dokumen-dokumen berikut—

Permohonan untuk mendapatkan kelulusan iklan peranti perubatan boleh dibuat mulai 4 Mei 2021 dengan mengikuti tatacara permohonan seperti yang dinyatakan dalam dokumen MDA/GL/04 serta menggunakan borang Permohonan Kelulusan Iklan Peranti Perubatan yang dilampirkan dalam dokumen tersebut.

MDA juga ingin memaklumkan bahawa penguatkuasaan sepenuhnya Peraturan-Peraturan ini akan bermula pada 1 Januari 2022.

Sementara itu, MDA akan mengelolakan satu siri latihan berkaitan pelaksanaan kawalan iklan di bawah Peraturan (Pengiklanan) Peranti Perubatan 2019 ini bagi memberi penerangan dan kefahaman mengenai kawalan pengiklanan peranti perubatan dengan lebih terperinci. Sila layari portal, www.mda.gov.my atau hubungi kami di talian 03-8230 0300 bagi mendapatkan maklumat lanjut. Sebarang pertanyaan boleh dipanjangkan melalui sistem pengurusan maklumbalas kami di https://femes.mda.gov.my/ atau emel consultation@mda.gov.my .

Ketua Eksekutif

Pihak Berkuasa Peranti Perubatan

Kementerian Kesihatan Malaysia

20 Mei 2021

 

ANNOUNCEMENT

 

Implementation of the Medical Devices (Advertising) Regulations 2019

Following the gazettement and the announcement of the implementation of the Medical Devices (Advertising) Regulations 2019, the Medical Devices Authority (MDA) would like to inform that the implementation of advertising control commenced on 4 May 2021. From the date of commencement, any establishments, advertising agencies or any person who wish to advertise any registered medical device may apply for advertisement approval from the MDA.

With the gazettement of these Regulations, any medical device advertisement shall meet the requirements set out in section 44 of the Medical Devices Act (Act 737) and the Medical Devices (Advertising) Regulations 2019. MDA has published the following documents to provide guidance to those who wish to advertise any registered medical device—

Application to get the approval for medical device advertisement can be made starting 4 May 2021. It shall be made in accordance with the procedures in document MDA/GL/04 and using the Medical Device Advertisement Approval Application form which is also attached in the document.

MDA would also like to inform that full enforcement of these Regulations will commence on 1 January 2022.

Meanwhile, MDA will organize a series of trainings related to the implementation of the Medical Devices (Advertising) Regulations 2019 to provide detail information and understanding on medical device advertising control. Please visit our portal, www.mda.gov.my or call us at 03-8230 0300 for more information. Any inquiries can be extended through our feedback management system at https://femes.mda.gov.my/ or email consultation@mda.gov.my .

Chief Executive

Medical Device Authority

Ministry of Health Malaysia

20 May 2021