SCOPE OF SERVICES

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1. COMPREHENSIVE REVIEW OF DEVICE TECHNICAL DOCUMENTATION AND COMPLETE GAP ANALYSIS

2. CONFIRMATION OF CORRECT RISK CLASSIFICATION (CLASS A-D) & REGISTRATION PROCESS

3. ADVISORY ON MDA REQUIREMENTS, APPLICABLE STANDARDS AND DOSSIER STRUCTURE IN READINESS FOR SUBMISSION & CONFORMITY ASSESSMENT

1. PREPARATION, SUBMISSION, AND END-TO-END MANAGEMENT OF PRODUCT REGISTRATION

2. COORDINATION WITH CAB AUDITORS & MDA OFFICERS & TECHNICAL EVALUATORS

3. SUBMISSION OF SUPPORTING TECHNICAL DOCUMENTATION (CSDT) AND MANUFACTURING CONFORMITY EVIDENCE

1. SERVE AS YOUR LEGALLY APPOINTED MALAYSIAN LICENSED AUTHORISED REPRESENTATIVE

2. MANAGE ALL REGULATORY CORRESPONDENCE, RENEWALS AND VIGILANCE REPORTING

3. MAINTAIN COMPLIANCE WITH POST-MARKET SURVEILLANCE OBLIGATIONS

1. HOLDING ALL 3 MDA LICENSES, WE CAN PROVIDE SEAMLESS END-TO-END MARKET ACCESS & SCALABILITY 

2. HOLDER OF MDA IMPORTER / DISTRIBUTOR LICENSES & FULLY CERTIFIED AND COMPLIANT WITH GDPMD TO PROVIDE CUSTOMS CLEARANCE MANAGEMENT, PRODUCT SECURE HANDLING AND NATIONWIDE DISTRIBUTION

3. NETWORK OF PARTNERS WITH PROCUREMENT ACCESS TO GOVERNMENT, HOSPITAL GROUPS AND CLINIC CHAINS. WE ARE STRUCTURED TO SUPPORT MARKET ADOPTION OF REGISTERED PRODUCTS