• 2026-10-26 09:33:44

The Ministry of Food and Drug Safety (MFDS) of South Korea has recently revised regulations concerning medical device adverse event reporting and Korean Good Manufacturing Practice (KGMP) and introduced a new regulation governing the designation and management of organizations involved in medical device quality management.
These regulatory updates aim to clarify adverse event reporting requirements and timelines, while improving regulatory clarity by separating KGMP conformity assessment requirements from provisions governing assessment bodies and training organizations.
This newsletter provides an overview of three regulatory updates that took effect on July 1 and September 22, 2026.

• 2026-10-26 09:17:04

This FAQ summarizes key regulatory resources and consultation opportunities relevant to the development and regulatory submission of Software as a Medical Device (SaMD) in Japan. The information is intended to support manufacturers in understanding regulatory expectations and planning efficient development and submission strategies throughout the product lifecycle.

• 2026-10-26 09:03:49

Australia's Therapeutic Goods Administration (TGA) updated its application audit selection criteria guidance, placing heightened pre-market focus on gynaecological curettes under Criterion 3 (Post-market signals). This article outlines how active post-market signals directly trigger non-mandatory application audits for medical devices, details the mandatory audit conditions under Regulation 5.3, and provides practical submission strategies for sponsors seeking Australian Register of Therapeutic Goods (ARTG) inclusion.

• 2026-10-09 01:44:32

Qualtech invites you to our free webinar on Thursday, October 29, 2026, with the topic "ASEAN Regulatory Briefing: Thailand & Malaysia - Critical Updates Impacting Medical Device Market Access".
Our local regulatory experts from Thailand and Malaysia will share practical insights into the latest regulatory changes, updated requirements, and key considerations affecting medical device registration and regulatory compliance. This session is highly recommended for all medical device manufacturers currently active in, or planning to enter, the Thailand and Malaysian market.

• 2026-09-21 05:48:49

China's obesity burden continues to rise, with about 57% of adults overweight / obese and the rate projected to reach 70.5% by 2030. At the same time, nearly 970 hospitals are estimated to be involved in bariatric and metabolic surgery nationwide, while China's bariatric surgery market is projected to grow from US$207M in 2026 to nearly US$398M by 2031. This article reviews the latest policy, clinical and market developments shaping opportunities in China's obesity-treatment and minimally invasive surgery sectors.

• 2026-09-23 03:31:24

Staying connected with the industry helps Qualtech keep its market knowledge current. Through our participation in CMEF Shanghai and BIO Asia–Taiwan 2026, we exchanged perspectives with manufacturers and industry professionals on market trends, regional expansion, and regulatory considerations across APAC.

• 2026-09-21 03:51:16

Singapore will progressively consolidate healthcare regulatory functions under the Health Sciences Authority (HSA), with functions currently performed by the Ministry of Health's (MOH) Health Regulation Group and subsequently the Secretariat of healthcare Professional Boards to be transferred to HSA. The transition will take place in two phases by the end of 2026 and 2027, respectively, as part of Singapore's move towards a more integrated healthcare regulatory system.

• 2026-09-21 03:40:18

Singapore's Health Sciences Authority (HSA) has enhanced its Change Notification (CN) process for registered medical devices. With immediate effect, up to two CN applications may now be processed concurrently for the same medical device listing, providing greater flexibility for stakeholders in managing regulatory changes and facilitating more timely implementation of device updates.

• 2026-09-21 03:23:41

The Philippine Department of Health has released a proposed Administrative Order establishing Good Manufacturing Practice (GMP) guidelines for local medical device and IVD medical device manufacturers. The proposed Order adopts PNS ISO 13485:2019 as the Food and Drug Administration (FDA)'s official GMP guideline and applicable PNS ISO 14644 standards for clean rooms. A two-year transitory period is proposed to allow affected manufacturers to comply with the new requirements once the Order takes effect.

• 2026-09-21 02:52:44

In Japan, Software as a Medical Device (SaMD) within certification criteria is reviewed and certified by Registered Certification Bodies (RCBs). Any product that exceeds the definition of its generic name, established certification standards, or the range of equivalence to predicate devices is subject to be reviewed by PMDA for approval.
Recently, it has been discovered that several cases in which the main and additional functions of SaMD products exceeded the certification scope. PMDA published this notice to prevent the recurrence of similar inappropriate certifications by standardizing and clarifying the requirements for describing software functions (Reference 1).