Medical Devices Registration in Malaysia (NPRA)
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Malaysia
Artixio provides comprehensive, end to end regulatory strategy, registration with NPRA and post approval maintenance and safety services for Medical Devices in Malaysia. Our regulatory consultants bring decades of experience in enabling commercialization of complex devices in the Malaysia.
The Medical Devices Market in Malaysia
Valued at US $2 Billion (est.)
Growing at a CAGR of 7.5%
60% of the World’s Medical Gloves 80% of Catheters Manufactured
95% Medical Devices Imported
Regulatory Authorities
Medical Devices in Malaysia are regulated by the Malaysian Medical Device Authority (MDA). All medical devices must be registered with the MDA before they can be sold in Malaysia. Since 2016, the MDA has mandated foreign manufacturers to register their medical devices under the Medical Device Act. It is also mandatory for manufacturers to obtain certification from Conformity Assessment Body (CBA) in order to receive approval from the MDA.
Class
Risk
Example
Class A
Minimal risk
Blood pressure cuffs, scissors, etc.
Class B
Love to Moderate risk
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Class C
Moderate to High risk
Implantable devices/devices
Class C
Highest risk
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Classification
Process
Appoint an Authorized Representative
• The Authorized Representative will be the license holder in Malaysia for foreign manufacturers.
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• The Authorized Representative will be responsible for post-approval maintenance of the licenses and post-market surveillance.
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• The Foreign Manufacturer can act as Authorized Representative if they have their subsidiary in Malaysia. Alternatively, their Distributor or MedTech Innovators can act as an Authorized Representative on behalf of the manufacturer..
Preparation of Common Submission Dossier Template (CSDT)
• The technical file in CSDT format is prepared and submitted to MDA by the Authorized Representative.
Certification from Conformity Assessment Body (CAB)​
• The Manufacturer needs to obtain a certificate from CAB to submit to the MDA for review and approval of CSDT.​
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• Reference Countries: Products approved in the USA, Canada, EU or Australia will advantage in faster review of application. A certificate from the CAB is mandatory.​
Documents Required for Registration of Medical Devices in Malaysia
Summary of Medical Device
Information related to the Manufacturer of Device
Device Classification
CSDT
Post Market Surveillance Data
Declaration of Conformity
Attestation of Medical Device
Medical Devices Registration Services in Malaysia
Marketing Authorization Holder (MAH) Services
Gap Analysis
Regulatory Intelligence and Strategy
Technical File Preparation and Submission
Clinical Evaluation and Post Marketing Evaluation
Response to Queries
Audit Support
Quality Training
Quality Management System Implementation
Consulting Services
We are helping global top 10 biopharma, devices, consumer health as well as many leading innovative small and mid sized companies using cutting edge consulting capabilities helping develop innovative products, solutions to address unmet medical, health and lifestyle needs among global population.
