Full Conformity Assessment for Medical Devices

The Full Conformity Assessment is a comprehensive evaluation process required by the Medical Device Authority (MDA) of Malaysia to ensure that medical devices comply with all applicable regulatory requirements. This assessment covers every aspect of the device’s lifecycle, from design and development to production, post-market surveillance, and more. Full conformity assessment is mandatory for high-risk (Class C and D) medical devices being marketed in Malaysia, as stipulated by the Medical Device Act 2012 (Act 737). The process is conducted by a recognized Conformity Assessment Body (CAB), such as TUV NORD Malaysia.

• Pre-Assessment Preparation (2-4 months)
  • Gap Analysis: Conduct a detailed review of your existing processes and documentation against regulatory requirements
  • Documentation Development: Prepare or refine technical files, risk management documents, and quality management system (QMS) procedures
  • Initial Consultation: Engage with TUV NORD Malaysia to plan the assessment process and identify specific needs
• Assessment Process (6-12 months)
  • Design and Development Evaluation: Detailed review of design processes, risk assessments, and verification/validation activities
  • Quality Management System (QMS) Audit: Comprehensive audit of your QMS to ensure compliance with MS ISO 13485 and other relevant standards
  • Manufacturing and Testing Review: Evaluation of manufacturing processes, testing protocols, and production quality controls
  • Addressing Non-Conformities: Implement corrective actions for any non-conformities identified during the assessment
• Post-Assessment and MDA Approval (1-2 months)
  • Final Assessment Report: Compilation of assessment findings and submission to the MDA for product registration
  • MDA Review and Approval: Await final approval from the MDA, following which your product can be legally marketed in Malaysia
• Ongoing Compliance and Surveillance (Ongoing)
  • Post-Market Surveillance: Continuous monitoring and reporting of device performance in the market
  • Periodic Audits: Regular audits to ensure continued compliance with regulatory requirements

• Unmatched Expertise
  • TUV NORD Malaysia brings extensive experience in conducting full conformity assessments for high-risk medical devices
  • Our team of seasoned auditors and industry experts possesses a deep knowledge of both Malaysian and international regulatory requirements
• Comprehensive Support Services
  • Offers a full range of services from initial consultation through to final certification and post-market surveillance support
  • Tailors the assessment process to meet your specific needs, ensuring a seamless and efficient certification journey
• Global Recognition and Credibility
  • TUV NORD is a globally recognized certification body, lending significant credibility to your full conformity assessment
  • Certification by TUV NORD Malaysia enhances your device’s reputation and facilitates easier entry into global markets
• Commitment to Excellence
  • Dedicated to maintaining the highest standards of quality and integrity in our assessment processes
  • Provides actionable feedback and recommendations to help you optimize your product and processes
• Efficient and Transparent Process
  • A clear, structured, and transparent certification process designed to minimize delays and disruptions
  • Consistent communication throughout the assessment, ensuring you are always informed of your progress and any emerging issues

For more information on how TUV NORD Malaysia can assist with your full conformity assessment for medical devices, please contact us at:

TUV NORD Malaysia 
Website: www.tuv-nord.com/my 
Phone: +603-2162 3561 
Email: malaysia@tuv-nord.com