• 2022-06-29 02:17:39

In April 2020, the Medical Device Authority (MDA) has issued a new Guidance Document regarding the classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices (MDA/GD/0061). This document guides the manufacturers and authorised representatives on classifying rehabilitation, physiotherapy, and speech therapy as medical devices.

• 2022-05-26 13:54:50

The Malaysian Medical Devices Authority (MDA) has decided to replace the requirement for lot-to-lot variation testing for the approval of new lots of COVID-19 test kits with the requirement under the establishment's post-market duties and obligations. With these, the establishment need to notify MDA of any new lot of the test kit that will be placed in the market.

• 2022-05-26 13:49:52

Screening and inspection of the importation of medical devices are being carried out at the main entry points of malaysia. This is one of the mechanisms to curb the activities of importing medical devices without a valid license, registration or authorization.

• 2022-04-27 11:25:06

The Malaysian Medical Device Authority (MDA) issued a new guideline document to assist in the registration application of COVID-19 IVD test kits via Medc@st for all previous applications that received Special Access Notification or Conditional Approval and new registration.

• 2022-03-25 11:49:26

The Medical Device Authority (MDA) produced this new Guidance Document to assist the medical device industry and healthcare practitioners in complying with the Medical Device Act (Act 737) and its regulations.

• 2022-02-18 08:27:38

The Medical Devices Authority (MDA) announced the notification prohibiting the sale of optical devices and contact lenses on any e-marketing platform except registered optometrists, opticians, and businesses registered with SSM, following standards published on the Malaysian Optical Council (MOC) official website.

• 2022-01-26 10:39:04

Malaysia's Medical Device Authority (MDA) has published the Fourth Edition of its Guidance Document on Medical Device Labelling Requirements. This guidance document is beneficial in informing stakeholders about the additional requirements and materials that must be included in medical device labelling marketed in Malaysia.

• 2021-12-27 06:12:43

MDA now recognizes MHRA, UK is now an additional recognized foreign regulatory agency by the MDA and its approval type for Great Britain and Northern Ireland can be used for medical devices to undergo a simplified registration route (by conformity assessment) in Malaysia.

• 2021-12-27 06:04:00

In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.

• 2021-11-24 10:12:53

In collaboration with the Ministry of Domestic Trade and Consumer Affairs (KPDNHEP), the controls for the expansion of self-test kit sales will be implemented. The Covid-19 self-test kit can only be purchased from licensed community pharmacies and authorized health facilities.