• 2025-10-27 04:49:01

To simplify preparation and expedite event organization, the Thai FDA announced that no advertising license is required for presenting medical devices at national, or international academic exhibitions and conferences. Academic events that meet the specified conditions may qualify for this exemption.

• 2025-10-27 04:30:17

List of selected frequently asked questions regarding the renewal of the medical device approval certificates. Originally in Thai, this English version offers practical guidance for maintaining compliance with Thai FDA requirements.

• 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.

• 2025-10-27 02:31:38

PMDA released a notification for the medical industry to reference the "Practical Guide for Radio Wave Management of Medical Telemetry Devices", prepared and released by the Electromagnetic Compatibility Conference Japan (EMCC). The purpose of the guide is to provide operational guidelines for radio management of medical telemeter systems (wireless physiological monitoring devices used in hospitals and healthcare facilities), ensuring interference prevention, safety, and proper use. In addition, the guide is intended to promote the development and utilization of practical manuals tailored to individual user groups, such as nurses, clinical engineers, and hospital administrators or administrative staffs.

• 2025-10-14 06:38:43

Join Qualtech's free webinar "Southeast Asia Medical Device Compliance Update Series 2025: Indonesia, Thailand & Vietnam" on October 28, 2025, to gain practical insights into 3 of ASEAN's fastest-growing medical device markets. Learn about key regulatory updates, compliance strategies, and market opportunities directly from Qualtech's local regulatory experts. Stay informed, compliant, and ready for growth in Southeast Asia.

• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-09-24 08:47:47

The Ministry of Food and Drug Safety (MFDS) has announced amendments to both the Enforcement Rules of the Medical Device Act and the Medical Device Standards. The revisions, implemented between April and August 2025, included higher fees for innovative medical device reviews, exemptions from documentation requirements, stricter administrative sanctions, and the establishment of long-term follow-up requirements. In addition, amendments to the Medical Device Standards have been finalized and are scheduled to take effect in July 2026, introducing new standards and aligning existing ones with international norms.

• 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.

• 2025-09-12 04:37:38

Qualtech will participate in the 46th Beijing International Medical Devices Exhibition on September 17–19, 2025. As one of China's premier MedTech events, the exhibition offers a key platform for engaging with healthcare stakeholders and exploring regional opportunities. Our team will be on-site to provide guidance on regulatory strategy and market access across APAC region.

Book a 1-on-1 session to meet us at the event!​