• 2026-04-28 08:33:22

The Medical Device Authority (MDA) has published the latest edition of the guidance document Definition of Medical Device which provides additional clarification on the definition and regulatory interpretation of medical devices, including accessories, components, and spare parts. The document is intended to assist industry stakeholders in the proper identification of device classifications and ensuring compliance with the Medical Device Act 2012 (Act 737).

• 2026-04-28 08:14:56

The Medical Device Authority (MDA) has published the new guidance document, Application for Confirmation Status of Obsolete and Discontinued Medical Device (MDA/GD/0071). This publication was to assist establishments and healthcare professionals in understanding the applicable regulatory framework and in implementing appropriate control measures for obsolete and discontinued medical devices.

• 2026-04-01 08:37:41

The Malaysia Medical Device Authority (MDA) has implemented Circular Letter No. 1 Year 2026 that enforces a compulsory licensing for all medical device tenderers to possess a valid Establishment License. Compliance with Act 737 and related regulations is mandatory, with penalties for violations.

• 2026-04-01 07:01:44

The Medical Device Authority (MDA), Malaysia, announces two key updates for medical device registration. The latest labelling guidance introduces e-labelling requirements, while conformity assessments conducted by Singapore's Health Sciences Authority (HSA) are now recognized through a verification-based process. These updates aim to streamline registration and ensure compliance for medical devices in Malaysia.

• 2026-02-26 08:25:34

The Malaysia Medical Device Authority (MDA) has officially gazetted the Medical Device (Designated Medical Device) Order 2026, effective on 1 June 2026. The Order involved medical device primarily used in aesthetic, therapeutic, and clinical settings. To enhance safety and mitigate risks, designated medical devices shall comply with Malaysian regulatory requirement for entering the Malaysian market.

• 2026-02-26 07:44:34

The Thai Food and Drug Administration (Thai FDA) and the Medical Device Authority (MDA) of Malaysia have initiated the Pilot Reliance Project, a joint effort to facilitate medical device registration by recognizing each othe's regulatory approvals. The pilot project is effective from February 2026 until 30 April 2026.

• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.

• 2025-12-26 03:31:27

The Malaysian Medical Device Authority (MDA) has implemented a Product Classification Letter with a two-years (2) validity in alignment with regulatory requirements. Letters issued before specified dates may expire or require renewal under the updated framework.

• 2025-11-21 08:14:15

The Malaysian Medical Device Authority (MDA) has issued the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], which were gazetted on 11 September 2025. This amendment revises the fee structure for registrations of Class A medical device effective on or after 1 January 2026. Stakeholders are advised to review the changes and plan their submissions accordingly to ensure timely compliance.

• 2025-11-10 07:33:05

Join Qualtech's upcoming webinar, "Southeast Asia Medical Device Compliance Update Series 2025 Part 2: Singapore, Malaysia & the Philippines", to gain valuable insights into three of ASEAN's most active and evolving medical device markets. This session will feature Qualtech's local regulatory experts, who will share the latest updates, policy trends, and compliance strategies across Singapore, Malaysia & the Philippines. Updates include current regulatory developments, harmonization efforts, and practical approaches to maintaining compliance while expanding in Southeast Asia.