Malaysia’s Medical Device Authority (MDA) announced changes to its Medical Device Product Classification Application System (PCAS) and to how long product classification letters stay valid. The changes took effect on October 1. The upgraded PCAS uses a simplified online form. Applicants now... Read More
Medical device registration in Malaysia is mandatory for any medical device imported, exported, or placed on the Malaysian market. The Medical Device Authority (MDA), an agency under the Ministry of Health, administers the registration system. Foreign manufacturers must work through a licensed... Read More
ASEAN member states have agreed in principle to roll out a Single Submission Model for pre-market medical device approvals in phases. Malaysia will serve as the coordinating hub for technical document submissions. The consensus came out of the first ASEAN Medical Device... Read More
Rare disease care across Asia is advancing on two fronts: faster regulatory pathways for orphan drugs, and slow-building efforts to fund and diagnose the roughly 258 million people in Asia living with rare conditions. China’s revised Drug Administration Law implementing rules, effective... Read More
On August 5, the Malaysian Ministry of Health (MOH) announced that it is introducing a Hologram Security Label for registered medical devices, building on a system it has used for pharmaceuticals since 2005. A hologram security label is a physical anti-counterfeiting sticker... Read More
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