SCOPE OF SERVICES
1 . REGULATORY ASSESSMENT & STRATEGY DEVELOPMENT
COMPREHENSIVE REVIEW OF DEVICE TECHNICAL DOCUMENTATION AND COMPLETE GAP ANALYSIS
CONFIRMATION OF CORRECT RISK CLASSIFICATION (CLASS A-D) & REGISTRATION PROCESS
ADVISORY ON MDA REQUIREMENTS, APPLICABLE STANDARDS AND DOSSIER STRUCTURE IN READINESS FOR SUBMISSION & CONFORMITY ASSESSMENT
2 . MEDICAL DEVICE REGISTRATION (VIA CAB & MEDC@ST)
PREPARATION, SUBMISSION, AND END-TO-END MANAGEMENT OF PRODUCT REGISTRATION
COORDINATION WITH CAB AUDITORS & MDA OFFICERS & TECHNICAL EVALUATORS
SUBMISSION OF SUPPORTING TECHNICAL DOCUMENTATION (CSDT) AND MANUFACTURING CONFORMITY EVIDENCE
3 . AUTHORISED REPRESENTATIVE (A/R)
SERVE AS YOUR LEGALLY APPOINTED MALAYSIAN LICENSED AUTHORISED REPRESENTATIVE
MANAGE ALL REGULATORY CORRESPONDENCE, RENEWALS AND VIGILANCE REPORTING
MAINTAIN COMPLIANCE WITH POST-MARKET SURVEILLANCE OBLIGATIONS
4 . MARKET SUPPORT & DISTRIBUTION ALLIGNMENT
HOLDING ALL 3 MDA LICENSES, WE CAN PROVIDE SEAMLESS END-TO-END MARKET ACCESS & SCALABILITY
HOLDER OF MDA IMPORTER / DISTRIBUTOR LICENSES & FULLY CERTIFIED AND COMPLIANT WITH GDPMD TO PROVIDE CUSTOMS CLEARANCE MANAGEMENT, PRODUCT SECURE HANDLING AND NATIONWIDE DISTRIBUTION
NETWORK OF PARTNERS WITH PROCUREMENT ACCESS TO GOVERNMENT, HOSPITAL GROUPS AND CLINIC CHAINS. WE ARE STRUCTURED TO SUPPORT MARKET ADOPTION OF REGISTERED PRODUCTS
WE ARE HAPPY TO PROVIDE A TAILORED SERVICE PROVISION FOR MARKET ACCESS AND ADOPTION, ALONG WITH TIMELINES AND FULL COST ANALYSIS UPON REQUEST
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