GDPMD Consultancy

In Malaysia, GDPMD certification is not only essential for companies involved in medical device distribution but also a prerequisite for obtaining an Establishment License (EL) from the Medical Device Authority (MDA). Under Medical Device Regulation 2012, Establishment License authorizes the company to import, store, distribute, or manufacture medical devices within the country. Companies seeking to apply for an establishment license must demonstrate compliance with GDPMD requirements as part of the licensing process. The certification signifies the company’s adherence to quality distribution practices, strengthening their position in the medical device industry and facilitating regulatory approval for their operations.

Our GDPMD training program allows participants gain a deep understanding of GDPMD guidelines, regulatory compliance, risk management, and quality control. The training also covers documentation essentials, ensuring efficient and compliant distribution processes. Moreover, our program keeps your team informed about the latest industry trends and regulatory changes, empowering your organization to maintain a leading position in the medical device distribution sector.

Our GDPMD audit assesses your distribution processes, documentation practices, risk management, and quality control procedures. We review your supply chain, storage, handling, and distribution practices to identify opportunities for improvement. Additionally, the audit ensures alignment with GDPMD guidelines, applicable regulations, and industry best practices, resulting in an optimized and compliant medical device distribution system that meets regulatory standards and enhances overall performance.

The GDPMD certification process involves two parties: the consultant and the certification body (CAB). For the consultant’s part, it typically takes approximately 2 to 4 months to complete the necessary assessments, gap analysis, and implementation of improvements. The certification body’s process usually takes around 1 month to conduct the final audit and issue the certification. However, in special cases, the entire process can be expedited and completed in as little as a month, as demonstrated in a previous case where urgent fulfillment of tender requirements was needed. Our team is dedicated to providing efficient solutions tailored to your specific needs and timeline.

We conduct a thorough review, develop tailored documentation, and provide regulatory guidance to align with GDPMD requirements. Besides, our GDPMD training will enhance your team’s awareness and compliance culture.

In Malaysia, to obtain GDPMD certification, you need to appoint two parties: the consultant and the certification body (CAB). The approximate cost for the consultant’s services typically starts from RM 6,000 to RM 9,000, while the certification body’s fees range from RM 3,000 to RM 5,000. However, please note that these costs are provided as a reference and may vary based on factors such as the types of medical devices, business size, and other unique requirements. For an accurate quote tailored to your company’s specific context, please contact our company to receive personalized pricing details.

The process for a medical device company to obtain GDPMD certification typically involves the following steps:

1. Engage a GDPMD Consultant: The company appoints a GDPMD consultant to guide them through the certification process and ensure compliance with GDPMD guidelines.
2. Gap Analysis: The consultant conducts a comprehensive gap analysis to assess the company’s current practices and identify areas that need improvement to meet GDPMD requirements.
3. Implementation of Improvements: Based on the gap analysis, the company implements necessary improvements to align with GDPMD standards and best practices.
4. Internal Audit: The consultant performs an internal audit to verify that the implemented changes meet GDPMD guidelines.
5. Certification Body Selection: The company selects a certification body (CAB) accredited by the Medical Device Authority (MDA) to conduct the final certification audit.
6. Final Certification Audit: The chosen CAB conducts the certification audit to assess the company’s compliance with GDPMD requirements.
7. GDPMD Certification: Upon successful completion of the audit, the company is awarded GDPMD certification, demonstrating their adherence to quality distribution practices for medical devices.

1. Industrial Knowledge: Our experienced team possesses in-depth industrial knowledge, understanding the nuances of medical device distribution and compliance requirements.
2. Fast-Track Implementation Program: We offer a dedicated fast-track program, fully committed to completing the certification project as quickly as possible without compromising on quality.
3. 100% Certification Guarantee: We are confident in our expertise and commitment to excellence, guaranteeing your company’s successful GDPMD certification.

The company is required to conduct an annual GDPMD internal audit and undergo a surveillance audit from the Certification Body each year.

The responsibility for complying with GDPMD shall include the authorized representative, importer, distributor, and logistics partners handling warehousing and transportation of the medical devices.