KKM : No Online Ad / Sale Of COVID-19 Rapid Test Kits!

The Malaysia Ministry of Health struck back at MYEG, admonishing them for advertising and promoting their COVID-19 rapid test kits without prior approval.

MYEG beat a hasty retreat, offering those who pre-ordered their rapid test kits a refund. Here are the details…

 

KKM : No Online Advertising / Sale Of COVID-19 Rapid Test Kits!

On 24 March 2020, the Medical Device Authority (PBPP) of the Malaysia Ministry of Health issued a statement, directly admonishing MYEG for advertising and promoting their COVID-19 rapid test kits without prior approval.

Allowing the online advertising and sale of such rapid test kits will increase the risk of infection, because the public does not have the necessary knowledge to interpret the results, or handle the situation should they receive a positive result.

MYEG vs KKM : Our COVID-19 Rapid Test Kits Are Real!

That’s why they believe the COVID-19 screening test should be performed by trained healthcare professionals in a health facility certified by the Ministry of Health.

The PBPP notes that while COVID-19 rapid test kits may receive Special Access exemptions to fast-track their availability in the market, it is NOT PERMITTED to promote them through advertisements.

In addition, the PBPP stressed that such “fast tracked” COVID-19 rapid test kits can only be distributed through authorised health facilities.

They also pointed out that anyone who contravenes the Medical Devices Act 2012 (Act 737) can be prosecuted via two sections :

  • Section 5(2) : Fined up to RM 200,000, or jailed up to 3 years, or both
  • Section 44(2) : Fined up to RM 300,000, or jailed up to 2 years, or both

Recommended : COVID-19 Rapid Tests : What You Need To Know!

 

MYEG : COVID-19 Rapid Test Kit On Hold With Refund

After the Malaysia Ministry of Health issued that statement, MYEG placed their their COVID-19 rapid test kits on hold.

They also offered a refund for those who already paid for their pre-ordered test kits.

Recommended : MYEG COVID-19 Rapid Test Kits Are Genuine, But…

 

The Official KKM Statement On The MYEG COVID-19 Rapid Test Kits

Here is the official statement by the Medical Device Authority of the Malaysia Ministry of Health on the MYEG COVID-19 rapid test kits.

Pengiklanan dan penjualan peranti Kit Ujian Pantas COVID-19 (COVID-19 Rapid Test Kit) dalam talian MYEG

Kementerian Kesihatan Malaysia (KKM) melalui Pihak Berkuasa Peranti Perubatan (PBPP) telah menerima pelbagai pertanyaan mengenai kit ujian pantas COVID-19 (COVID-19 rapid test kit) yang diiklan dan dijual secara dalam talian melalui portal MYEG. Kami ingin memaklumkan semakan mendapati PBPP tidak pernah mengeluarkan apa-apa kebenaran kepada MYEG untuk mengiklan, mengedar atau menjual peranti kit ujian pantas COVID-19 ini.

Paparan iklan yang dibuat oleh pihak MYEG ini boleh menimbulkan kekeliruan dan menggalakkan pembelian di kalangan orang awam. Keadaan ini boleh meningkatkan risiko jangkitan kerana dikhuatiri orang awam tidak mempunyai pengetahuan yang mencukupi untuk menginterpretasi keputusan ujian yang diperolehi dan mengendalikan situasi setelah mendapat keputusan ujian tersebut. Ujian pengesanan jangkitan COVID-19 perlu dilakukan oleh kakitangan kesihatan yang berkelayakan dan terlatih di fasiliti kesihatan yang diiktirafkan KKM untuk memastikan pengendalian dan rawatan pesakit dilakukan mengikut prosedur yang ditetapkan dan dengan itu dapat mengekang penularan wabak berkenaan.

Mana-mana syarikat atau establismen yang hendak membekalkan kit ujian COVID-19, hendaklah dipastikan peranti tersebut berdaftar dan syarikat telah mempunyai lesen establismen di bawah Akta Peranti Perubatan 2012 (Akta 737) yang sah. Walau bagaimanapun, semasa penularan wabak ini, mana-mana syarikat atau establismen boleh membuat notifikasi untuk pengecualian daripada pendaftaran bagi peletakan peranti kit ujian COVID-19 di pasaran melalui akses khas (special access). Mana-mana peranti kit ujian COVID-19 yang telah memperolehi pengecualian ini, pengiklanan peranti tersebut tidak dibenarkan sama sekali dan pengedaran hendaklah dibuat secara langsung ke premis-premis kesihatan yang telah dibenarkan. Mana-mana orang yang disabitkan kesalahan dalam hal ini boleh dikenakan hukuman denda tidak melebihi dua ratus ribu ringgit (RM200,000) atau penjara bagi tempoh tidak melebih dua (2) tahun atau kedua-duanya sekali di bawah seksyen 5(2) Akta 737, dan/atau dikenakan hukuman denda tidak melebihi tiga ratus ribu ringgit (RM300,000) atau penjara bagi tempoh tidak melebih dua (2) tahun atau kedua-duanya sekali di bawah seksyen 44(2) Akta yang sama.

PBPP akan terus memantau pengiklanan, pengedaran dan penjualan kit ujian COVID-19 di pasaran termasuk penjualan dan pengedaran melalui platfom dalam talian bagi memastikan kit ujian COVID-19 yang berada di pasaran adalah selamat dan berkesan digunakan. Orang ramai dinasihatkan agar tidak mudah terpengaruh dengan mana-mana iklan berkaitan kit ujian COVID-19 dan sentiasa mengambil langkah-langkah pencegahan jangkitan sebagaimana yang disarankan oleh KKM. Bagi mana-mana pihak yang ingin mengetahui status pendaftaran kit ujian COVID-19 semakan boleh dibuat dengan menghubungi PBPP melalui talian 03-82300300 atau email, [email protected].

Ketua Eksekutif

Pihak Berkuasa Peranti Perubatan

Kementerian Kesihatan Malaysia

Here is our English translation :

MYEG online advertising and sale of COVID-19 Rapid Test Kit

The Ministry of Health Malaysia (KKM) through the Medical Device Authority (PBPP) received many queries about the COVID-19 Rapid Test Kit that was advertised and sold online through the MYEG portal.

We would like to publicly state that our review found that Medical Device Authority never authorised MYEG to advertise, distribute or sell this COVID-19 rapid test kit.

The advertisement by MYEG can confuse and promote purchase by the public. This situation can increase the risk of infection because the public does not have enough knowledge to interpret the test results and handle the situation after obtaining the test results.

The COVID-19 diagnostic test must to be performed by healthcare workers who are qualified and trained in health facilities certified by the Ministry of Health to ensure that the handling and treatment of patient is done according to protocol and thus curb the spread of the epidemic.

Any company that would like to supply COVID-19 Test Kits should be ensure that the device is registered and the company has a legal establishment license under the Medical Devices Act 2012 (Act 737).

However, during this outbreak, any company or establishment can make a request for the exemption of registration for the provision of the COVID-19 test kits in the market through Special Access. If a COVID-19 test kit received such an exemption, it is not permitted to advertise such a device at all, and it should only be made available in permitted health establishments.

Any person who is convicted of this offence can be fined not more than two hundred thousand ringgit (RM 200,000) or jailed for a period of not exceeding two (2) years, or both, under Section 5(2) of Act 737, and/or fined not more  three hundred thousand ringgit (RM 300,000), or jailed for a period of not exceeding two (2) years, or both, under Section 44(2) of same Act.

The Medical Device Authority (PBPP) will continue to monitor the advertising, distribution and sales of the COVID-19 test kits in the market, including online sales and distribution to ensure that the COVID-19 test kit that is in the market is safe and effective to use.

The public is advised not to be easily influenced by any advertisements on COVID-19 test kits and always take the preventive steps as recommended by the Ministry of Health.

Anyone who wishes to know the registration status of any COVID-19 test kit can contact PBPP by calling 03-82300300 or emailing [email protected]

Chief Executive
Medical Device Authority
Ministry of Health Malaysia

 

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