Achieving GDPMD certification is a critical step for medical device distributors in Malaysia. However, many companies encounter delays, additional costs, or even certification failures due to avoidable mistakes.
This article highlights the most common pitfalls during the GDPMD certification process and offers practical solution to overcome them.
Mistake 1: Incomplete Documentation
Companies often fail to prepare essential SOPs or maintain proper records. Missing documentation for complaint handling, product recall, or distribution can lead to non-conformities.
Solution: Establish comprehensive SOPs aligned with GDPMD requirements and ensure all records are consistently updated.
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Mistake 2: Poor Storage and Handling Practices
Medical devices require controlled storage conditions. Issues such as lack of temperature monitoring, inadequate segregation, or improper labelling are frequently found during audits.
Solution: Implement temperature and humidity monitoring system, calibrate equipment regularly, and clearly label storage areas.
Mistake 3: Insufficient Employee Training
Untrained employees may not follow SOPs correctly, resulting in error during storage, handling, or documentation.
Solution: Conduct regular GDPMD training sessions for all relevant staff and maintain detailed training records.
Mistake 4: Weak Traceability System
Inability to trace medical devices from supplier to customer is a major compliance issue. This becomes critical during product recalls.
Solution: Implement a reliable inventory or ERP system that tracks batch and lot numbers and maintains accurate distribution records.
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Mistake 5: Skipping Internal Audits
Some organizations skip internal audits because they do not have certified internal auditors on staff. Instead, they proceed directly to the external certification audit. This often leads to non-conformities that could have been identified and corrected earlier, causing delays or even audit failures.
Solution: Internal audits should always be conducted by certified internal auditors to ensure credibility and compliance with GDPMD requirements. Companies can address this by sending their employees for internal auditor training to become certified, or by engaging a qualified consultant to perform the audits.
Mistake 6: Engaging a Non-Recognized Certification Body
Working with certification bodies not recognized by the MDS will render the GDPMD certificate invalid.
Solution: Verify that the certification body is included in MDA’s approved list before engagement. For your reference, please visit the following website: https://mdar.mda.gov.my/frontend/web/index.php?r=carian-cab
Conclusion
Avoiding these common mistakes is key to achieving GDPMD certification efficiently and without unnecessary delays. Proper documentation, employee training, traceability, and internal audits significantly reduce the risk of non-compliance.
At Flexly Consulting Sdn Bhd, we specialize in helping businesses prepare for GDPMD certification. Our team provides end-to-end support, including system development, staff training, and pre-audit assessments. Contact us today to ensure your certification process is smooth, compliant, and successful.
