Comprehensive Regulatory Affairs Solutions
for APAC & Global Markets
RABT Global is a specialist in comprehensive regulatory affairs solutions for medical devices and pharmaceuticals, supporting global and APAC market access through expert consulting, registration, and compliance services.
🌏 APAC Country Coverage
PMDA & Regional Submissions
TGA & Regional Submissions
CDSCO
Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines
Global Reach — APAC and Worldwide
RABT supports clients from startups to large corporations, expediting approvals and reducing operational costs while ensuring timely, compliant product launches in APAC and worldwide.
🇰🇷 South Korea
🇦🇺 Australia
🇳🇿 New Zealand
🇮🇳 India
🇸🇬 Singapore
🇲🇾 Malaysia
🇻🇳 Vietnam
🤝 Our Promise: Partnering with RABT Global ensures your medical devices go beyond local compliance — achieving rigorous certification, swift market entry, and sustainable success in Asia-Pacific and global markets.
Supporting Global and APAC Market Access
RABT Global differentiates itself by leveraging industry-leading expertise and a proactive, client-focused approach — enabling life science innovators to navigate complex regulations and achieve rapid market adoption, including in rapidly evolving APAC regulatory environments.
Partnering with RABT Global ensures your medical devices go beyond local compliance — achieving rigorous certification, swift market entry, and sustainable success in Asia-Pacific and global markets.
RABT Global’s Offerings Include
We deliver regulatory support for medical devices across APAC and worldwide — from QMS guidance through post-market surveillance.
Quality Management System (QMS) Services
Guidance and auditing aligned with ISO 13485 and country-specific requirements, enabling robust quality frameworks and readiness for market access.
ISO 13485
Documentation and Submission Support
Preparation and review of technical files, dossiers, translations, and communication with regulatory agencies such as China NMPA, Japan PMDA, India CDSCO, Australia TGA, Singapore HSA.
Dossier & Submission
Local Representation
Acting as in-country authorized representatives where needed, facilitating smooth regulatory interactions.
Local Representation
Post-Market Surveillance
Vigilance, adverse event reporting, and ongoing compliance monitoring for continuous market success.
Post-Market
Global Reach
RABT supports clients from startups to large corporations, expediting approvals and reducing operational costs while ensuring timely, compliant product launches in APAC and worldwide.
Global
We Deliver Regulatory Support for Medical Devices In
We deliver regulatory support for medical devices across APAC and other APAC members as needed.
North & South APAC
Japan, South Korea, Australia, New Zealand, India
Japan — PMDA
South Korea
Australia — TGA
New Zealand
India — CDSCO
Southeast Asia
Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines
Singapore — HSA
Malaysia
Thailand
Indonesia
Vietnam
Philippines