• 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.

• 2021-10-27 07:06:19

Effective from June 17, 2021, MDA now allows multiple authorized representatives for each medical device (brand name) placed in the market. On the other hand, they will restrict to requiring individual establishment licenses to carry out role/activity of various economic operators, as prescribed in the Medical Device Regulations 2012.

MDA Circular Letter No. 1/2014 contains two components, which are the establishment that acts as an authorized representative (AR) and the establishment that carries out various activities.

• 2021-09-29 02:11:24

MDA wants to advise any organization interested to import and distribute the Covid-19 Self-Test Kit for the Malaysian market to apply through the Conditional Approval Application with MDA.

• 2021-09-29 02:05:59

Starting July 1, 2022, MDA will start to fully enforce the Medical Device (Duties and Obligations) Regulations 2019 or better known as 2019 Regulations. The regulations focus on various medical device-related establishments’ responsibilities on post-market activities.