Medical Device Authority

What Medical Device Authority does

Medical Device Authority (MDA) is a Malaysian federal statutory agency established on 15 March 2012 under the Ministry of Health Malaysia pursuant to the Medical Device Authority Act 2012 (Act 738), with full operations commencing 16 June 2012. MDA is the sole regulator responsible for implementing and enforcing the Medical Device Act 2012 (Act 737), governing pre-market registration, establishment licensing, product classification, advertisement approval, post-market surveillance, and enforcement for all medical devices placed on the Malaysian market.

MDA operates a portfolio of interconnected e-government platforms anchored by MeDC@St 2.0+ (Medical Device Centralised Online Application System) for registrations and licensing, MEDCREST for mandatory problem reporting and recalls, MDAR for public verification of registrations, FEMES for complaints, the Product Classification System, BayarNow for fee payments, and an e-Training Academy. The agency's revenue model is fee-based under the Medical Device Regulations 2012, with prescribed charges for manufacturer licenses (RM 4,000 new / RM 2,000 renewal), authorized representative licenses, importer and distributor licenses (RM 2,000 / RM 1,000), certificates of free sale, and advertisement approvals.

MDA's customer base spans medical device manufacturers, authorized representatives, importers, distributors, healthcare institutions, and healthcare professionals, all subject to Act 737 oversight. The agency engages internationally with WHO, WTO, ASEAN/ACCSQ, GHWP, APEC, IMDRF, ISO, and IEC, and has recently extended regulatory reach into e-commerce (Lazada Malaysia) and digital advertising (ByteDance Malaysia) channels while piloting a bilateral evaluation pathway with China NMPA. Governance is provided by a Board of Directors chaired by a senior Ministry of Health figure, with Dr. Muralitharan Paramasua serving as Chief Executive.

Name

Medical Device Authority

Legal name

Medical Device Authority (MDA), Ministry of Health Malaysia

Website

https://portal.mda.gov.my

Company type

Private

Founded year

2012

Operating status

Operating

Short description

Medical Device Authority (MDA) is Malaysia's federal statutory agency under the Ministry of Health that regulates medical devices — handling registration, establishment licensing, post-market surveillance, and advertisement approval — for manufacturers, importers, distributors, and authorized representatives operating in Malaysia.

Ownership category

akta.pro rank

Product category

Medical Device Regulation

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615)

SIC

Services-Health Services (8000)

akta.pro primary industry

Medical Device Regulators (HLAJADAC)

Keywords

• Medical device regulation
• Medical device registration
• Establishment licensing
• Post-market surveillance
• Regulatory compliance

Headquarters

HQ city

Selangor

HQ country

Malaysia

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Medical Device Registration Fees: Fees collected for registration of medical devices under Act 737, including new registrations, re-registrations, and change notifications.
2. Establishment License Fees: Fees for issuance and renewal of establishment licenses for manufacturers, authorized representatives, importers, and distributors. Manufacturer license: RM 4000 new, RM 2000 renewal. Multi-role licenses require separate applications.
3. Certificate of Free Sale / Manufacturing Certificate: Fees for issuance of certificates for medical devices intended for export or domestic sale.
4. Advertisement Approval Fees: Fees for evaluation and approval of medical device advertisements under Section 44 of Act 737.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels8 records

Core offering

Medical Device Authority (MDA) is a federal statutory agency under the Ministry of Health Malaysia that regulates medical devices in Malaysia under the Medical Device Authority Act 2012 (Act 738) and Medical Device Act 2012 (Act 737). Its core offering is regulatory oversight of medical devices across pre-market registration, establishment licensing, post-market surveillance, and enforcement. It delivers these services through a digital platform ecosystem including MeDC@St 2.0+, MDAR, MEDCREST, FEMES, Product Classification System, BayarNow, and e-Training Management System.

Product overview

Medical Device Authority (MDA) Malaysia operates a portfolio of interconnected e-Government platforms for medical device regulatory oversight under the Medical Device Act 2012 (Act 737) and Medical Device Authority Act 2012 (Act 738). The core platform is MeDC@St 2.0+ (Medical Device Centralised Online Application System), which handles medical device registration, re-registration, change notifications, and establishment licensing. Supporting platforms include MEDCREST for post-market surveillance and vigilance reporting, FEMES for complaints and feedback management, and MDAR for public verification of registered devices and licensed establishments. Additional services include the Product Classification System for device categorization, RIS for regulatory information subscription, e-Training for industry professional development, EMS for event management, and BayarNow for cashless payment processing. These systems collectively form a digital regulatory ecosystem supporting pre-market control, post-market surveillance, enforcement, and industry facilitation functions.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Authority Register (MDAR) Public search portal allowing verification of medical device registration status and establishment license information by the public and industry stakeholders.
• Medical Device Centralised Online Application System 2.0+ (MeDC@St 2.0+) Centralized online application system for medical device registration, re-registration, change notifications, and establishment licensing. Includes automated re-registration route for streamlined market access. Target users are manufacturers, authorized representatives, importers, and distributors.
• Medical Device Centralized Reporting System (MEDCREST) System for post-market surveillance and vigilance reporting including mandatory problem reporting, field corrective actions, and medical device recall submissions used by manufacturers, healthcare professionals, and the public.
• MDA Feedback Management System (FEMES) System for receiving and managing complaints related to criminal misconduct, violations of organizational ethics, and enforcement complaints from the public and industry.
• Product Classification System (PC) Online portal for product classification applications to determine whether a product is categorized as a medical device or non-medical device. Transitioned to fully online application process for industry users.
• Regulatory Information Subscription (RIS) Subscription service providing regulatory updates and information dissemination to stakeholders regarding medical device regulations and MDA announcements.
• Event Management System (EMS) Platform for managing MDA training events, seminars, and industry engagement activities including registration and scheduling.
• MDA e-Training Management System Online training management system for MDA Academy (COE) including speaker registration, syllabus management, and training schedule for industry professionals on GDPMD, ISO 14971, and medical device sterilization topics.
• BayarNow Cashless Payment Gateway Cashless payment gateway enabling industry to pay for licenses, certificates, and other MDA services online.
• Certificate of Free Sale / Manufacturing Certificate (CFS) Online system for issuance of Free Sale Certificates and Manufacturing Certificates for medical devices intended for export or domestic sale, with separate CFS application management portal.

Quantifiable outcome

• Full operation since 16 June 2012, serving the Malaysian medical device industry for over a decade

Named customers3 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• China NMPA (National Medical Products Administration)coreStrategic or Co-development Partner · 1 July 2026Malaysia-China Joint Evaluation Pilot Programme (Phase 2: 1st July to 30 September 2026) for accelerated medical device approval process.
• ByteDance MalaysiaminorChannel Partner/ Reseller/ Distributor · 14 May 2026Stakeholder engagement meeting with ByteDance Malaysia regarding medical device advertising on digital platforms.
• Lazada MalaysiacoreChannel Partner/ Reseller/ Distributor · 12 May 2026Collaboration to strengthen online medical device control through Lazada's e-commerce platform. Session held at Cyberjaya on 12 May 2026.
• World Health Organization (WHO)coreStrategic or Co-development PartnerInternational cooperation with WHO on medical device regulatory matters and global health standards harmonization.
• World Trade Organization (WTO)coreStrategic or Co-development PartnerCollaboration on trade-related regulatory matters affecting medical device imports and exports.
• ASEAN (Association of Southeast Asian Nations)coreStrategic or Co-development PartnerRegional cooperation through ACCSQ (ASEAN Consultative Committee on Standards and Quality) for harmonized medical device regulations.
• Global Harmonization Working Party (GHWP)coreStrategic or Co-development PartnerInternational collaboration for harmonizing medical device regulatory frameworks. Hosted 28th GHWP Annual Meeting in Kuala Lumpur, Malaysia.
• APEC (Asia-Pacific Economic Cooperation)coreStrategic or Co-development PartnerRegional economic cooperation forum engaging in medical device regulatory harmonization activities.
• IMDRF (International Medical Device Regulators Forum)coreStrategic or Co-development PartnerInternational forum for medical device regulatory convergence and cooperation.
• ISO (International Organization for Standardization)coreStrategic or Co-development PartnerTechnical standards cooperation for medical device quality and safety standards (e.g., ISO 13485, ISO 14971).
• IEC (International Electrotechnical Commission)coreStrategic or Co-development PartnerTechnical standards cooperation for electrical medical devices and equipment.
• Kementerian Perdagangan Dalam Negeri dan Kos Sara Hidup (KPDN)coreStrategic or Co-development PartnerInter-agency collaboration between KPDN enforcement division and MDA for domestic trade and cost of living issues related to medical devices.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Pharmaceuticals and Medical Devices Agency (PMDA), Japan: Japan's combined regulatory agency for pharmaceuticals and medical devices. Comparable in providing pre-market review, post-market safety measures, and as an IMDRF member with significant regional regulatory influence in Asia.
• China National Medical Products Administration (NMPA): China's national medical device regulator. Explicitly mentioned as a bilateral cooperation partner through the Joint Evaluation Pilot Programme, making it a directly comparable peer in scope, regulatory framework maturity, and emerging-market regulatory convergence.
• Singapore Health Sciences Authority (HSA): Singapore's multi-product health regulator covering medical devices, pharmaceuticals, and complementary products. Comparable as a Southeast Asian peer regulator with a strong digital registration framework (MEDICS) and ASEAN regulatory harmonization leadership.
• U.S. Food and Drug Administration (FDA) – Center for Devices and Radiological Health (CDRH): The U.S. federal regulator for medical devices under the FD&C Act. Most directly comparable to MDA in function (pre-market approval, post-market surveillance, establishment registration) though operating at much larger scale and with global influence through MDSAP participation.
• Therapeutic Goods Administration (TGA), Australia: Australia's regulator for therapeutic goods including medical devices under the Therapeutic Goods Act. Directly comparable in scope (ARTG registration, conformity assessment, post-market monitoring) and as an MDSAP member with strong international harmonization activity.
• Indonesia – Badan Pengawas Obat dan Makanan (BPOM): Indonesia's national regulator for food, drugs, cosmetics, and medical devices. Comparable as the largest ASEAN medical device regulator with similar regulatory framework scope and ASEAN harmonization participation.
• Thailand Food and Drug Administration (TFDA): Thailand's medical device regulator under the Medical Device Act. Direct ASEAN peer with comparable scope in registration, licensing, and post-market surveillance; relevant for regional regulatory harmonization comparisons.
• Health Canada – Medical Devices Directorate: Canada's federal medical device regulator under the Medical Devices Regulations. Comparable in statutory mandate covering pre-market licensing, post-market surveillance, and MDSAP participation, though serving a single national market.
• UK Medicines and Healthcare products Regulatory Agency (MHRA): The UK's medical device regulator post-EU exit. Comparable in statutory medical device oversight including UKCA marking, post-market surveillance, and as an IMDRF member with strong innovation frameworks for AI/SaMD.

Broad incumbents

• European Commission – DG SANTE (Medical Devices): Oversees the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR), implemented through Notified Bodies rather than a single agency. Comparable as a higher-level regulatory authority though structurally distinct from a single national agency like MDA.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCCdsH5L_BPlk4KzWwEg3OvA
• Facebookfacebook.com/MedicalDeviceAuthority
• LinkedInlinkedin.com/company/mdamalaysia
• Instagraminstagram.com/medical_device_authority/?hl=en

Revenue estimate

Valuation estimate

Number of profiles

Profiles22 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medical Device Authority