Product Conformity Assessment by Way of Verification

The Medical Device Authority (MDA) of Malaysia requires certain medical devices to undergo a product conformity assessment to ensure they meet the necessary safety, performance, and quality standards before being placed on the market. The conformity assessment by way of verification is a crucial process that involves evaluating the product’s compliance with regulatory requirements through documentation review, testing, and other verification activities. This process is mandatory for manufacturers, importers, and distributors of medical devices in Malaysia under the Medical Device Act 2012 (Act 737). The assessment is conducted by a recognized conformity assessment body (CAB), such as TUV NORD Malaysia.

• Pre-Assessment Preparation (1-2 months)
  • Documentation Review: Prepare and submit all necessary technical documentation, including design, risk management, and manufacturing processes
  • Initial Consultation: Engage with TUV NORD Malaysia to understand the specific requirements for your product.
• Assessment Process (2-4 months)
  • Verification Activities: TUV NORD Malaysia conducts a thorough review of documentation, testing, and other necessary verification activities
  • Addressing Non-Conformities: Implement corrective actions for any issues identified during the assessment.
• Post-Assessment and Registration (1-2 months)
  • Final Review: TUV NORD Malaysia finalizes the assessment and provides a report
  • Submission to MDA: Submit the assessment report to the MDA for product registration.
• Ongoing Compliance (Ongoing)
  • Continuous Monitoring: Regular reviews and updates to ensure ongoing compliance with regulatory requirements
  • Surveillance Audits: Periodic audits to maintain conformity and address any emerging issues

• Extensive Expertise
  • TUV NORD Malaysia has a wealth of experience in conducting conformity assessments for a wide range of medical devices
  • Our team includes experts with deep knowledge of Malaysian regulations and global standards
• Comprehensive Assessment Services
  • Provides a full suite of services, from initial consultation to post-assessment support, ensuring a seamless certification process
  • Tailors the assessment process to meet the specific needs of your product and organization
• Global Recognition
  • TUV NORD is an internationally recognized certification body, adding significant value and credibility to your conformity assessment
  • Our certification is widely respected, facilitating easier market access and international recognition of your products
• Commitment to Quality
  • We are committed to upholding the highest standards of quality in our assessment services
  • TUV NORD Malaysia provides actionable insights to help you improve your product and meet regulatory requirements efficiently
• Efficient and Transparent Process
  • Streamlined and transparent assessment process with clear timelines to minimize disruptions
  • Consistent communication throughout the process, keeping you informed of your product’s progress

For more information on how TUV NORD Malaysia can assist with your product conformity assessment by way of verification, please contact us at:

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