ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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The Medical Devices Market in Singapore
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
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.
Regulatory Authorities
Class
Risk
Analysis
Blood presure cuffs, scissors, etc
Minimal risk
Class A
Low to Moderate risk
Class B
Implantable devices/devices
Moderate to High risk
Class C
Highest risk
Class D
Classification
Process
Documents Required for Registration of Medical Devices in Malaysia
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Summary of Medical Device
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Information related to the Manufacturer
of Device -
Device Classification
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CSDT
-
Post Market Surveillance Data
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Declaration of Conformity
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Attestation of Medical Device
Medical Devices Registration Services in Malaysia
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Marketing Authorisation Holder (MAH) Services
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Gap Analysis
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Regulatory Intelligence and Strategy
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Consultation and Meeting
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Technical File Preparation and Submission
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Quality Management System Implementation
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Audit Support
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Quality Training
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Response to Queries
-
Clinical Evaluation and Post Marketing
Evaluation
Appoint an Authorized Representative
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The Authorised Representative will be the license holder in Malaysia for foreign manufacturers.
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The Authorised 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 Authorised Representative if they have their subsidiary in Malaysia. Alternatively, their Distributor or Artixio can act as an Authorised Representative on behalf of the manufacturer.
Preparation of Common Submission Dossier Template (CSDT)
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The technical file in CSDT format is prepared and submitted to MDA by the Authorized Representative.
Certification from Conformity Assessment Body (CAB)
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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.
Explore how we can help your MedTech Product launch in Malaysia.
Services Offered
Market Size & Landscape Analysis
KOL Analysis
Price Sensitivity Analysis
Distributor Search and Licensing
Market Access
Marketing Authorization Holder
Post Market Maintenance
Post Market Surveillance Query Responses
Authorized Representative
Regulatory Intelligence & Strategy, Gap Analysis, Remediation and Submission
Regulatory Affairs
QMS Implementation
ISO 13845 Consulting, 21 CFR
820, SOP Development, Audits
Quality Management
Clinical evaluation reports (MEDDEV 2.7.1)
Clinical investigation protocols and reports
Medical Writing & Medical Review
Clinical Services
Contact our team
With Our Expert Regulatory Team based at our Regional Office in Malaysia, Artixio can act as your Authorized Representative and help you launch your products successfully in the country from Strategy, Registration to Post Market Support.
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