GDPMD

Good Distribution Practice for Medical Devices (GDPMD) is a certification standard established by the Medical Device Authority (MDA) of Malaysia. The GDPMD certification ensures that organizations involved in the supply chain of medical devices—including importers, distributors, and authorized representatives—comply with the regulatory requirements for the safe distribution and handling of medical devices. GDPMD certification is mandatory under the Medical Device Act 2012 (Act 737) for companies involved in the importation, storage, distribution, and management of medical devices in Malaysia.

• Pre-Certification (1-3 months)
  • Gap Analysis: Review current practices against GDPMD requirements
  • Documentation Preparation: Develop or update procedures and documentation to align with GDPMD standards
  • Training: Conduct training sessions to ensure staff are aware of GDPMD requirements
• Certification Process (3-6 months)
  • Stage 1 Audit: Initial audit to assess readiness for GDPMD certification
  • Stage 2 Audit: Detailed audit to verify full compliance with GDPMD requirements
  • Corrective Actions: Address any non-conformities identified during the audit
• Post-Certification (Ongoing)
  • Surveillance Audits: Regular audits by the certification body to ensure ongoing compliance with GDPMD
  • Continuous Improvement: Ongoing monitoring and improvement of processes to maintain certification

• Proven Expertise
  • TUV NORD Malaysia has extensive experience in certifying organizations involved in the medical device supply chain
  • Our auditors have in-depth knowledge of GDPMD requirements and the regulatory environment in Malaysia
• Comprehensive Services
  • Offers end-to-end certification services, including consultation, auditing, and post-certification support
  • Tailored solutions to fit your organization's specific needs, ensuring a smooth and effective certification process
• Global Recognition
  • TUV NORD is an internationally recognized certification body, adding credibility to your GDPMD certification
  • Our certification is respected globally, facilitating easier partnerships with international suppliers and customers
• Commitment to Quality
  • TUV NORD Malaysia is committed to delivering the highest quality certification services
  • We provide actionable insights and recommendations to help you improve your distribution processes continuously
• Transparent and Efficient Process
  • A clear and efficient certification process with defined timelines to minimize disruptions
  • Transparent communication throughout the certification journey, ensuring that you are always informed of your progress

For more information on how TUV NORD Malaysia can assist with your GDPMD certification, please contact us at:

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