A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

Medical Device Consultation in Japan

Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).

Australia’s SaMD Regulatory Deadline

Beginning on November 1st, 2024, Australia’s Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.

Philippines FDA Extends CMDN Deadline to 2024

The Philippines Center for Device Regulation, Radiation Health and Research (CDRRHR) has announced that Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to September 30, 2024.

Hong Kong MDD Adds Singapore as Reference Country

Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.

Philippines Incentivizing Local Medical Device Manufacturing

On March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.

China’s Third Batch of UDI Implementation Deadline in June

Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.

Thai FDA Reduces Application Review Time

On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.

Hong Kong MDD Adds China and Korea to List of Reference Countries

Starting January 1st, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China and the Ministry of Food and Drug Safety (MFDS) of Korea as support of compliance of the medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS. 

Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit

On October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India’s largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, “Paving the way for a USD 50 billion MedTech Industry by 2030,” signifying a collective vision for the industry’s future growth.

Philippines FDA Bans Mercury-Added Products

Released on June 13, 2022, the Philippines FDA released FDA Circular No.2022-003 banning the manufacture and sale of mercury-added products including thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes.