Translate
31 December 2019
KKM arah henti jualan peranti 'Headphone kurangkan kadar gula'
KKM arah henti jualan peranti 'headphone kurangkan kadar gula'
Bernama | Disember 30, 2019 21:29 MYT
NOOR HISHAM: Tahap keselamatan dan keberkesanan peranti berkenaan tidak dapat disahkan. - Gambar fail
KUALA LUMPUR: Kementerian Kesihatan (KKM) pada Isnin mengarahkan pihak syarikat yang mengedar peranti 'headphone' yang didakwa boleh mengurangkan dan mengawal kadar gula dalam darah supaya menghentikan penjualan dan pengedaran peranti itu serta-merta.
Ketua Pengarahnya Datuk Dr Noor Hisham Abdullah berkata tahap keselamatan dan keberkesanan peranti berkenaan tidak dapat disahkan kerana semakan oleh Pihak Berkuasa Peranti Perubatan (PBPP) mendapati ia tidak berdaftar di bawah Akta Peranti Perubatan 2012 (Akta 737).
Sehubungan itu, beliau berkata penjualan dan pengedaran peranti itu perlu dihentikan serta merta sehingga ia diluluskan di bawah Seksyen 5 Akta 737 dan syarikat memperolehi lesen establismen yang sah di bawah Seksyen 15 akta yang sama.
"Berdasarkan keperluan perundangan, sesuatu peranti perubatan yang hendak diimport, dieksport dan diletakkan dalam pasaran, hendaklah terlebih dahulu didaftarkan di bawah Seksyen 5 Akta 737.
"Dalam proses pendaftarannya tahap keselamatan serta keberkesanannya akan dinilai serta disahkan. Sebarang tuntutan perubatan yang dibuat hendaklah disokong dengan bukti-bukti saintifik dan klinikal selain peranti tersebut hendaklah memenuhi prinsip-prinsip keselamatan dan keberkesanan," kata dalam kenyataan pada Isnin.
Ia sebagai maklum balas terhadap artikel bertajuk "Headphone bantu kurangkan kadar gula pesakit diabetes" yang dilaporkan dalam sebuah portal bertarikh 20 Dis lepas sehingga menimbulkan pelbagai reaksi orang awam yang menzahirkan kebimbangan terhadap keselamatan dan keberkesanan peranti itu.
Dr Noor Hisham berkata penjualan dan pengedaran peranti perubatan yang tidak berdaftar atau tanpa lesen establismen yang sah merupakan satu kesalahan dan jika disabitkan boleh dikenakan denda tidak melebihi RM200,000 atau penjara tidak melebihi tiga tahun atau kedua-duanya.
Pada masa yang sama, katanya sebarang bentuk tuntutan perubatan berkaitan sesuatu peranti perubatan yang disiarkan bagi tujuan pengiklanan hendaklah mematuhi keperluan iklan yang digariskan mengikut Seksyen 44 Akta yang sama dan Peraturan (Iklan) Peranti Perubatan 2019.
Menurutnya, mana-mana orang yang membuat dakwaan yang mengelirukan atau palsu tentang sesuatu peranti perubatan di dalam iklan merupakan kesalahan dan jika disabitkan, boleh dikenakan denda tidak melebihi RM300,000 atau penjara tidak melebihi tiga tahun atau kedua-duanyai.
Orang awam terutama pesakit yang sedang menerima rawatan perubatan bagi penyakit kronik disaran supaya mendapatkan nasihat daripada ahli profesional kesihatan berdaftar sebelum menggunakan mana-mana peranti selain menyemak status pendaftarannya dengan melayari portal rasmi PBPP https://portal.mda.gov.my/.
-- BERNAMA
Popular Posts - Last 7 days
-
‘Alas pintu’ dengan gambar Kaabah sebenarnya sejadah mini - AEON BiG April 13, 2024 Susulan penularan gambar yang mendakwa penjualan ‘alas ...
-
Screenshot of a video shared by the public of the incident at the Kuala Lumpur International Airport (KLIA) Arrival Hall 1 on Sunday. SEPANG...
-
Malaysia detects 3,902 new COVID cases, 8 deaths Melissa Fernando ASTRO AWANi Julai 20, 2022 Malaysia detects 3,902 new COVID cases, 8 de...
-
King expresses hope for increased investment from Chinese companies in Malaysia Bernama April 12, 2024 His Majesty Sultan Ibrahim presented...
-
MAN DIES AS HIS BMW I7 CRASHES AND BURNS, WOMAN FRIEND SERIOUSLY INJURED A man died while his woman friend was seriously injured when the ca...
-
Naz Empire's defamation lawsuit against Awal Ashaari to go to trial as mediation fails Bernama Julai 12, 2022 The defamation lawsuit f...
-
Mohd Shuhaily said the suspect had two previous records for threats and another record for stealing and impersonating a civil servant. - BER...
-
Coach Maloney and FAM part ways after eight years Bernama Julai 13, 2022 The Football Association of Malaysia (FAM) has released under fir...
-
Saudi says application for 1444 H umrah visa opens from today Bernama Julai 14, 2022 The Ministry of Haj and Umrah of Saudi Arabia has ann...
-
Summons discount offer on WhatsApp is fake - PDRM Bernama Julai 17, 2022 14:11 MYT Summons discount offer on WhatsApp is fake - PDRM The Ro...
Popular Posts - Last 30 days
-
Wan Saiful confirms he is no longer PTPTN chairman Bernama Julai 12, 2022 Bersatu Information chief Datuk Wan Saiful Wan Jan today confirm...
-
Saudi says application for 1444 H umrah visa opens from today Bernama Julai 14, 2022 The Ministry of Haj and Umrah of Saudi Arabia has ann...
-
Kedah MB: ECK no longer part of Kulim airport project Bernama Julai 13, 2022 Muhammad Sanusi announced that the ECK Group of Companies (EC...
-
King presents appointment letters to four new envoys Bernama Julai 12, 2022 His Majesty presenting the letter of appointment to M'sian...
-
Following is BEST FBKL's selection of The Top Ramadan 2024 Buka Puasa Buffet's in Kuala Lumpur and the Klang Valley. We hope that y...
-
Naz Empire's defamation lawsuit against Awal Ashaari to go to trial as mediation fails Bernama Julai 12, 2022 The defamation lawsuit f...
-
Paris court grants Malaysia's application to suspend claims by purported heirs of Sultan Jamalul Kiram II Bernama Julai 13, 2022 Dr Wa...
-
Maybank Singapore withdraws lawsuit against NFC chairman, children over housing loans Bernama Julai 12, 2022 Maybank Singapore Limited has...
-
COVID-19: New cases in Malaysia take a slight dip again Melissa Fernando ASTRO AWANI Julai 19, 2022 12:00 MYT COVID-19: New cases in Malays...
Blog Archive
-
►
2023
(3771)
- December (311)
- November (322)
- October (286)
- September (288)
- August (365)
- July (349)
- June (372)
- May (316)
- April (279)
- March (301)
- February (245)
- January (337)
-
►
2022
(4309)
- December (352)
- November (422)
- October (288)
- September (281)
- August (347)
- July (303)
- June (335)
- May (406)
- April (341)
- March (371)
- February (390)
- January (473)
-
►
2021
(9030)
- December (636)
- November (647)
- October (809)
- September (797)
- August (880)
- July (894)
- June (747)
- May (780)
- April (580)
- March (629)
- February (643)
- January (988)
-
►
2020
(6800)
- December (819)
- November (698)
- October (832)
- September (729)
- August (548)
- July (558)
- June (615)
- May (394)
- April (368)
- March (453)
- February (439)
- January (347)
-
▼
2019
(4089)
- December (411)
- November (425)
- October (375)
- September (279)
- August (397)
- July (353)
- June (326)
- May (315)
- April (266)
- March (318)
- February (293)
- January (331)
-
►
2018
(4100)
- December (305)
- November (304)
- October (357)
- September (352)
- August (420)
- July (442)
- June (366)
- May (412)
- April (343)
- March (275)
- February (233)
- January (291)
-
►
2017
(3888)
- December (268)
- November (293)
- October (352)
- September (309)
- August (356)
- July (300)
- June (319)
- May (354)
- April (316)
- March (335)
- February (306)
- January (380)
-
►
2016
(4563)
- December (331)
- November (328)
- October (378)
- September (415)
- August (404)
- July (380)
- June (310)
- May (370)
- April (430)
- March (484)
- February (355)
- January (378)
-
►
2015
(4588)
- December (402)
- November (392)
- October (393)
- September (375)
- August (450)
- July (392)
- June (456)
- May (407)
- April (408)
- March (374)
- February (262)
- January (277)