India’s Ministry of Health and Family Welfare has proposed amendments to the 2017 Medical Devices Rules to simplify and speed up the licensing process for medical device manufacturing. A draft notification was published in the Official Gazette for public comment, with the... Read More
Malaysia’s Medical Device Authority (MDA) has established an Innovative Medical Device Review (IMDR) program to assist developers of novel medical technologies seeking to align with regulatory expectations before formal product registration. The IMDR program is specifically for innovative medical devices, which are generally... Read More
In late December, Malaysia’s Ministry of Health (MOH) announced a new requirement regarding the use of a FarmaTag hologram security label on drug products. The measure is intended to strengthen labeling and authentication requirements. Also, it will enhance safeguards against counterfeit medicines and improve... Read More
In December 2025, Malaysia’s Medical Device Authority (MDA) published for public comment its draft First Edition of Guidance on the management of changes to registered medical devices. This guidance is an important milestone in how modifications to registered medical devices will be... Read More
Malaysia’s Medical Device Authority (MDA) and Thailand’s Food and Drug Administration (Thai FDA) have recently signed a Confidentiality Agreement and launched a three-month regulatory reliance pilot to accelerate medical device approvals and reduce duplicate reviews in each country. Announced in early December 2025,... Read More
Singapore’s Health Sciences Authority (HSA) has officially opened its new electronic Common Technical Document (eCTD) portal for test submissions. This represents an important move towards the process of digitalizing regulatory submissions for therapeutic products. The eCTD Specification Package version 1.0 will be... Read More
Device registration in Malaysia is done by a Local Authorized Representative (LAR) for foreign device manufacturing companies without a physical presence in Malaysia. The normal device registration process includes going through a detailed conformity assessment before making a registration application submission. In... Read More
India has released a draft bill calling for greater accountability from clinical trial sponsors and contract research organizations (CROs). Companies will need to pay damages and treat participants who suffer from injuries during any trials. If the trial sponsors do not comply, companies would face a... Read More
Malaysia’s Ministry of Health (MOH) has recently announced that it will factor real-world evidence (RWE) in its decision-making for the inclusion of drugs into its national formulary – the “Blue Book.” This change signals a shift toward moving beyond reliance on clinical trial data alone and toward... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More