ABOUT US
MDDEV
MEDICAL TECHNOLOGY CONSULTANCY
MdDev Sdn Bhd is a company incorporated in Malaysia with a team of MedTech specialists over 25 years in various subject matters, expertise, providing technical consultation, medical technology training and project management in healthcare technology, medical devices and regulatory affairs.
OUR VISION
Our vision for MdDev is to build a world-class consulting firm driven by total commitment to excellent services and compliance to regulations set out by the world regulators.
OUR MISSION
MdDev aims to enable growth in people and organisations through effective knowledge empowerment and methodology application to achieve excellence in best practices within the medical technology sector.
OUR SERVICES
MEDICAL TECHNOLOGY & REGULATORY PROJECT CONSULT
We assist you with development of documentation for project proposal
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Medical device technical & regulatory documentation based on WHO, IMDRF, Good Regulatory Practice (GRP) & relevant international standards
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Hospital support services Documentation (Biomedical Engineering Maintenance Services, Facility Engineering Maintenance Services, Facility Management Services) based on Ministry of Health Policy, international Standards & regulatory requirements
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Maintenance management, testing, commissioning documentation & disposal for medical devices in Healthcare Institution
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MedTech Startup Launchpad
Your Complete Pathway to Entering Malaysia’s Medical Device Market
We can assist new medical device entrepreneurs through MDDEV’s MedTech Startup Launchpad - our end-to-end support platform that ensures a compliant, strategic & successful entry into the Malaysian medical device market
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Company Establishment Support: Guidance on setting up a new MedTech company in Malaysia
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MDA Establishment Licence (EL): Identify the requirements on organisation
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Regulatory strategy & documentation review-requirements for product registration
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Distributor and partner identification, including market mapping and business matching
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Market entry & commercialisation support, connecting clients with healthcare networks & assisting with product placement & launch strategies
ESTABLISHMENT LICENSE
We can assist with the development of regulatory documentation & establishment license applications in Malaysia & ASEAN member states.
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Development of regulatory documents for the establishment license as an authorized representative, distributor, importer & manufacturer
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Assist with MeDC@St 2.0 online establishment registration application in Malaysia
QUALITY MANAGEMENT SYSTEM
Customized development of documentation for quality assurance program in Malaysia & ASEAN member states
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ISO 13485:2016 specifies requirements for a quality management system for organizations involved in manufacturing medical devices
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Good Distribution Practice for Medical Devices (GDPMD) for authorised representatives, distributors & importers in the medical device supply chain
MEDICAL DEVICE & IVD REGISTRATION
We review, evaluate & compile medical device technical documentation for medical devices, IVD & refurbished medical devices for registration & follow up with the competent authority until the issuance of the registration certificate in Malaysia & ASEAN member states.
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Development of documents for medical devices with premarket regulatory approvals
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Development of technical documents for medical devices without regulatory approvals
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Assist with MeDC@St2.0 online medical device registration application in Malaysia
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CFS Application
Conferences, Seminars, Webinars and Training
We provide expert advice in organizing MedTech programs in Malaysia & ASEAN member states
We have the professional & HRDF registered trainers to provide medical device regulatory & quality management training in Malaysia & ASEAN member states
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Collaboration with universities, to organize medical technology training programs
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Registration of medical devices
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GDPMD
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ISO13485:2016
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CE Marking, USFDA 510k and Pre-market authorization
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Certified by Human Resource Development of Malaysia
EVENTS
4-DAY CHINA MEDICAL DEVICE INDUSTRY PROGRAM
BRIDGING INNOVATION & COMPLAINCE: UNLOCKING MEDICAL DEVICE OPPORTUNITIES IN MALAYSIA
10-13 NOVEMBER 2025
Kuala Lumpur & Selangor,
Malaysia
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