• 2025-10-27 03:24:28

The Malaysia Medical Device Authority (MDA) has published the latest Conformity Assessment Body (CAB) guide and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment by Way of Verification process, which includes updates on additional recognized regulatory authorities and revised verification procedures to help establishments streamline registration and ensure regulatory compliance.

• 2025-10-27 02:53:36

The Malaysian Medical Device Authority (MDA) has been recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP). MDA will now accept MDSAP audit reports and certificates as evidence of QMS compliance, streamlining device registration and reducing audit duplication for manufacturers.

• 2025-09-24 10:06:53

Malaysia has emerged as a dental powerhouse, attracting international patients with world-class treatments at affordable prices, while fueling one of ASEAN's fastest-growing dental device markets. With over 3,700 private clinics and a nationwide network of public facilities, the country is well-positioned to meet rising demand driven by medical tourism and a tech-savvy private sector. Yet, Malaysia also faces a domestic oral health challenge, highlighting both the urgency and the opportunity for innovation.

• 2025-09-24 08:22:59

The Medica Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme to streamline approvals for Class B–D devices. The main purpose are to fast-track market access, cutting cost, reducing duplication and enhanced patient care.

• 2025-08-25 03:35:27

The Ministry of Health Malaysia (MOH) has announced an international regulatory collaboration with China National Medical Products Administration (NMPA). This collaboration aims for accelerate pre-market approvals, quicker market access, reduced costs and enhanced patient care while strengthens Malaysia's role as regional regulatory hub.

• 2025-07-10 10:12:51

Malaysia Medical Device Authority (MDA) has announced that the re-registration function will be made available in the upgraded MeDC@St 2.0+ system exactly one year before the expiration date of the registration certificate. The implementation helps establishment in better planning and managing device re-registration and change notification in advance.

• 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

• 2025-05-29 09:42:50

Malaysia Medical Device Authority (MDA) authority issues the new guidance documents of Importation of Medical Device for Re-export (IRE), MDA/GD/0069 in March 2025. This guidance document outlines the procedure for importing medical devices into Malaysia for re-export purposes. It is particularly beneficial for importers and manufacturers by providing clear regulatory steps, approval requirements, and compliance guidelines to facilitate smooth procedure.

• 2025-03-25 03:01:27

Effective March 1, 2025, all medical device advertisement applications must be submitted exclusively through the online Google Form platform. This transition is designed to enhance operational efficiency, simplify the submission process, and provide a smoother, more user-friendly experience for all applicants.

• 2024-10-10 09:23:31

The Medical Device Authority (MDA) announced the outcomes and implementation plan for the MDA-CAB 2023 Workshop held on December 6–7, 2023, as well as the current MDA-CAB 2024 Workshop Series I scheduled for March 1, 2024.