• 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.

• 2026-09-21 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).

• 2026-09-21 02:42:09

The Department of Health (DH) of Hong Kong issued a letter regarding the updated regulatory requirements for the use of injectable and infusible product in licensed Private Healthcare Facilities (PHFs) which cover pharmaceutical products, human organ/human tissue product, and medical device. For medical devices, the DH has announced that all injectable and infusible medical devices used in licensed PHFs must be listed under the MDACS, effective 1 March 2027. This new requirement specifically includes injectable dermal fillers and injectable mucous membrane fillers.

• 2026-08-25 04:02:15

Planning to enter or expand your medical device business in Japan or South Korea? Join Qualtech's free webinar on September 17, 2026, for a focused discussion on key regulatory developments shaping medical device market access in these two important Asian markets.
The session will cover practical considerations for leveraging existing biocompatibility reports for PMDA requirements and navigating South Korea’s evolving framework for digital healthcare products and digital medical devices.

• 2026-08-25 07:50:09

The Medical Device Authority (MDA) of Malaysia has announced the new Automated Re-Registration Route within the MeDC@St 2.0+ platform, effective from 13 July 2026. This initiative aims to support continuous product availability, reducing administrative workload, and improving regulatory efficiency while maintaining compliance with existing MDA requirements.

• 2026-08-25 07:35:09

The Ministry of Health Malaysia (MOH) will gradually implement a Hologram Security Label for registered medical devices to help identify genuine, registered products with the Medical Device Authority (MDA) and prevent the sale of counterfeit and unregistered devices. The official announcement is scheduled to be made during IMDEC 2026 event on 26 August 2026.

• 2026-08-25 04:50:05

Indonesia's medical device regulatory framework places increasing emphasis on demonstrating compliance with applicable healthcare standards through appropriate testing and validation. Manufacturers and applicants should ensure that the required test results, validation documents, and supporting certifications are available as part of the product registration and compliance process. Recent requirements highlighted for in vitro diagnostic products (IVDs) include specific provisions for performance testing, instrument connectivity, and software validation.

• 2026-08-25 04:38:17

The Hong Kong Department of Health (DH), through its Medical Device Division (MDD), has established the "Novo Lane" under the Medical Device Administrative Control System (MDACS) to prioritize the processing of eligible innovative medical device listing applications. The initiative is intended to facilitate earlier access to innovative medical technologies while maintaining regulatory oversight of medical device safety and performance. As part of its regulatory approach, the MDD continues to monitor the safety and performance of listed medical devices after they are placed on the market.