• 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.

• 2025-10-27 01:46:53

The 2025 update of the FDA-CDRRHR Citizen's Charter introduces notable changes from its 2024 version, reflecting the agency's continued refinement of service standards, including adjustments in processing timelines.

• 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 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 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.

• 2025-09-24 07:40:52

PMDA has revised the approach to biological safety evaluation and abolished the previous notification issued on Jan 6, 2020. The revised approach focuses on providing practical instructions for preparing regulatory submissions.

• 2025-09-24 07:20:49

The FDA has issued draft guidance on marketing submissions for AI-enabled device software functions (AI-DSFs), with a focus on using a predetermined change control plan (PCCP). A PCCP allows manufacturers to plan and manage software changes in a predictable and controlled way, making regulatory review smoother and device performance more reliable.

• 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!​