Asia-Pacific Roundup: Malaysia, Thailand implement medical device reliance program after successful pilot
Agencies in Malaysia and Thailand have implemented a regulatory reliance program for medical devices after a successful three-month pilot.
Malaysia's Medical Device Authority (MDA) and the Thai Food and Drug Administration (Thai FDA) signed a confidentiality agreement to deepen collaboration in December 2025. The agencies piloted the medical device reliance program from February to April 2026. Having completed the pilot, the agencies have transitioned to the full implementation of the program.
Effective immediately, companies that have received Thai FDA approval for a medical device can use MDA’s verification process to bring the product to market in Malaysia. Bypassing the full evaluation route streamlines the regulatory process in Malaysia. The conformity assessment process takes about 1.5 months, after which MDA requires 14 to 30 working days to review the paperwork, depending on the class of medical device.
The Thai FDA has set up an equivalent program. Any devices approved in Malaysia can bypass the external expert evaluation with the full common submission dossier template filing. MDA said bypassing that step significantly streamlines the local registration process. The program strengthens the regional medical device ecosystem and supports timely access to medical devices in both countries, MDA said.
During the pilot, the reliance model significantly optimized the registration process for Class B, C, and D medical devices by leveraging the regulatory reviews of a trusted partner, MDA said. MDA and the Thai FDA reduced regulatory duplication, accelerated medical device launches, and improved patient access to healthcare technologies, according to the Malaysian regulator.
The program provided a streamlined path to market “while simultaneously ensuring safety, upholding rigorous performance standards through increased administrative efficiency,” MDA said. The agency cited the “supportive participation of industry stakeholders” in the pilot as evidence of the success of the initiative.
Transitioning to full implementation continues MDA’s expansion of its reliance program. In recent months, Singapore’s Health Sciences Authority and the Thai FDA have joined bodies in Australia, Canada, the European Union, Japan, the UK, and the US on the list of regulatory authorities or notified bodies recognized by MDA.
Indian Pharmacopoeia Commission seeks feedback on bacterial endotoxin test rules
The Indian Pharmacopoeia Commission (IPC) has released draft guidelines on bacterial endotoxin tests for consultation.
IPC has proposed changing the section of the existing guidelines about alternate test methods. The draft text lists gel-clot limits test, semi-quantitative gel-clot, kinetic turbidimetric, kinetic chromogenic, and endpoint chromogenic methods as validated methods for the detection of endotoxins, components of bacterial cell walls that can cause fever, shock, and organ failure if present in drug products.
All the validated methods are mentioned in another section of the guidelines. Laboratories may choose a method that is not mentioned elsewhere in the document provided they meet certain criteria, IPC said in the draft guidelines.
The alternate test must be fully validated to ensure that decisions based on its output are “equivalent to or better than decisions made using the validated pharmacopoeial methods and ultimately approved by the appropriate regulatory authority,” IPC said.
IPC named recombinant Factor C (rFC) and recombinant cascade reagents (rCR) as examples of alternate tests. Traditionally, bacterial endotoxin testing has used reagents sourced from horseshoe crabs. Interest in animal-free alternatives fueled research into recombinant DNA technology, leading to the creation of rFC and rCR.
Both reagents contain the recombinant Factor C constituent of the clotting cascade, while rCR also includes Factor B and the proclotting enzyme. Authorities around the world have supported use of the reagents in recent years as part of a push to improve testing and reduce the harvesting of crabs.
IPC shared the guidelines alongside other draft proposals. The pharmacopeia is seeking feedback on text about the effectiveness of antimicrobial preservatives, checking water for injection for contamination, and other topics. IPC is accepting feedback until 11 June.
Malaysia’s NPRA launches inspection dashboard to strengthen regulatory oversight
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published a dashboard of data on its inspection activities.
The dashboard covers good clinical practice (GCP), good laboratory practice, bioequivalence, and ethics committee inspections. NPRA has collated data on its inspections and their outcomes since 2019 on an interactive dashboard. The dashboard shows how often NPRA inspected each type of site, the reason for the inspection, the number of inspections by year, and how often sites were noncompliant.
Other sections of the dashboard provide a detailed, and in some cases longer-term, analysis of specific types of inspection. The GCP section details the minor, major, and critical findings identified by NPRA inspectors since 2014. NPRA has divided the data by category, revealing the number of compliance issues related to topics such as informed consent and subject protection.
The dashboard is part of NPRA’s efforts to strengthen regulatory oversight and enhance transparency, in line with the principles of the World Health Organization’s Global Benchmarking Tool. NPRA is encouraging stakeholders, including sponsors, contract research organizations, and bioequivalence centers, to refer to the dashboard for information on its inspections.
Philippine FDA meets with e-commerce platforms to stop online health product sales
The Philippine Food and Drug Administration (FDA) has stepped up efforts to stop the online sale of unregistered health products.
FDA said it met with representatives of the e-commerce platforms Lazada and Shopee to discuss ways to address the “continuous presence of violative health products being sold through online platforms.” The agency discussed aligning regulatory requirements with the platforms’ existing systems and processes, particularly in the reporting, review, and takedown of flagged products.
Representatives from Lazada and Shopee expressed openness to improving their systems for detecting and removing non-compliant listings, FDA said. The platforms have safeguards in place, but all parties see room for improvement.
FDA sought the companies’ support for a proposed memorandum of cooperation developed with the Department of Trade and Industry’s E-Commerce Bureau. The proposal is intended to establish a clearer framework for joint efforts to curb online sales of non-compliant health products.
Australian court fines company $1.3M over import and supply of COVID-19 tests
The Federal Court of Australia has ordered Key Promotional Products (KPP) to pay AU$1.75 million ($1.3 million) for the unlawful import and supply of COVID-19 tests.
KPP allegedly imported and supplied more than 240,000 units of unapproved COVID-19 detection rapid antigen test kits to Australian retailers between January and March 2022. The court also ruled that KPP made more than 2,300 false or misleading representations in claiming that the tests were approved by Australia’s Therapeutic Goods Administration (TGA).
The tests were not included in the Australian Register of Therapeutic Goods and had no exemptions or approvals that permitted their sale or supply in Australia, TGA said. Tests need to be registered, or have written approval or exemption, to be lawfully imported and supplied.
The court ordered the spouse of KPP’s registered director to pay AU$250,000 for managing the company’s day-to-day operations and knowingly aiding and abetting the unlawful import and supply of the tests, TGA said.
Other News:
The World Health Organization selected the Translational Health Science and Technology Institute, India, as its biomanufacturing training center in Southeast Asia. The institute is one of six centers around the world that will provide training aligned with regional priorities and regulatory environments. Press Release
