On 1 December 2025, the Medical Device Authority (MDA) issued an important update regarding the enforcement timeline for the Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. The update provides: A revised enforcement date for the mandatory Import Permit requirement Continued application of existing
The Thai FDA has issued a clarification and reminder that all types of contact lenses whether used for medical or aesthetic purposes are classified as medical devices in Thailand. This announcement aims to promote consumer safety by preventing improper use, ensuring that only high quality and compliant products reach customers,
Overview of the New Circular On 22 November 2025, the Vietnam Ministry of Health (MoH) issued a new Circular detailing updated administrative procedures and regulatory requirements for medical device management. The Circular provides: Specific assignments of authority to the Infrastructure and Medical Device Administration (IMDA) Updated requirements for documentation and
The Medical Device Authority (MDA) of Malaysia has issued an announcement regarding the implementation of a validity period for the Product Classification Letter, effectively revoking the previous announcement dated 1 April 2025. To read the full announcement: Implementation of Validity Period for Product Classification Letter [link] Key Updates 1. Introduction
The Medical Device Authority (MDA) of Malaysia has issued a media statement reminding all stakeholders of their responsibilities concerning the online sale, advertising, and distribution of medical devices under the Medical Devices Act 2012 (Act 737). To read the full announcement: MDA Reminder on Registered Medical Devices [link] Key Updates
The Ministry of Health of the Republic of Indonesia has announced the temporary closing of the Online Medical Device Licensing System (Regalkes) and the Online Certification System (e-SUKA). This measure is carried out in accordance with Minister of Health Regulation No. 11 of 2025 concerning business and product/service standards within
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
