The Malaysia and Singapore Healthcare Sectors to Teaming up to Showcase a Pilot Program

Announcement

Singapore’s Health Sciences Authority (HAS) and Malaysia’s Medical Device Authority (MDA) revealed a pilot program that will leverage access to class B, C, and D medical devices. The pilot program will start on 1st September onwards and will run through 28 February. The agencies believe the pilot will help to receive quick approvals and diminish duplication of reviews, and fast patient access to innovative, quality, and safe medical technologies. They focus on doing so by depending on each other’s approvals and assessments.

The devices registered with HAS might go through an abridged review via MDA’s conformity assessment body. The verification path will lessen the review time to 30 working days from 60 under the full conformity assessment path. The devices registered with MDA will benefit from this abridged review by HAS, which will calculatively reduce the review duration by 30% throughout class B and D medical devices. The pilot will examine the streamlined route, develop and refine standard operating procedures, validate the short timeline of processing, and collect feedback.

Regulatory Highlights

Overall, the work is a part of a massive and strong coordination between the two agencies. This pilot program, announced by MDA, was introduced quickly after indulging in a similar involvement with China’s national medical products administration. The agreement rewards companies with device accessibility and authorization in Singapore or China, with quick reach to the Malaysian market. The industries with the approvals in Malaysia have received an advantage from their pipeline access to Singapore and China.

India’s Central Drugs Standard Control Organization (CDSCO) has published an alert about numerous obesity drugs and Novo Nordisk diabetes that were not available in transit as it was stolen. The Philippine Food and Drug Administration actively responded to feedback on the upgradation plans to guidelines on the dedicated use of unauthorized vaccines, medical devices, and unauthorized drugs.

Further, the CDSCO has given a certain time to manufacturers until 1st March 2026 to update QR and bar codes on drug packaging, including the information of the excipients applicable in their products. The Philippine FDA also alerted the public regarding the circulation of counterfeit vaccines that pose an extreme risk to safety and health.

Chief executive at MDA, Muralitharan Paramasua, said, “This strategic collaboration plans to diversify market opportunities, boost technical confidence in the medical device regulatory system, and shows up as a testament to the enduring and close professional relationship between Singapore and Malaysia.”