ISO 13485 Medical Devices Quality Management Systems / Good Distribution Practice for Medical Devices (GDPMD)

What is ISO 13485:2016?

ISO 13485:2016 is an international standard for quality management systems (QMS) specific to the medical device industry. It provides a framework for organizations involved in the design, development, production, installation, servicing, and sales of medical devices to establish and maintain a QMS that ensures compliance with regulatory requirements and the consistent delivery of safe and effective medical devices.

The standard is applicable to all manufacturers and providers of medical devices, components, contract services and distribution of medical devices. 

Key requirements of ISO 13485:2016 include:

1. Regulatory Compliance: Ensuring that the organization complies with relevant regulatory requirements and standards specific to the medical device industry.
2. Quality Management System: Establishing and maintaining a QMS that encompasses all relevant processes and functions within the organization.
3. Management Responsibility: Demonstrating leadership and commitment to the QMS by top management, including setting quality policy and objectives.
4. Resource Management: Ensuring that the necessary resources, including personnel, infrastructure, and work environment, are available for the effective functioning of the QMS.
5. Product Realization: Addressing all aspects of product development, from design and development through production, installation, servicing, and final delivery.
6. Measurement, Analysis, and Improvement: Implementing processes for monitoring, measurement, analysis, and continual improvement of the QMS and product quality.
7. Documentation and Records: Creating and maintaining documentation that supports the QMS and its processes, including records of quality-related activities.

About GDPMD

With the effective date (1 July 2013) of Act 737 and Medical Device Regulations 2012, manufacturers and distributors of medical devices are required to apply for their establishment license to continue carrying out their manufacturing, distribution or importing activities.

Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors, Importers and Local Authorized Representative require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment License.

Key Requirements of GDPMD in Malaysia include:

1. Licensing and Registration: Companies involved in the distribution of medical devices are typically required to obtain the necessary licenses and registrations to operate legally in Malaysia.
2. Quality Management System: GDPMD emphasizes the need for a robust quality management system (QMS) to ensure the proper handling and distribution of medical devices. This includes implementing standard operating procedures, document control, and records management.
3. Storage and Transportation: Proper storage and transportation conditions must be maintained to prevent damage or deterioration of medical devices. This may include temperature and humidity control, appropriate packaging, and safe handling practices.
4. Product Traceability: The ability to trace the movement and location of medical devices within the supply chain is a fundamental requirement. This ensures that any issues or recalls can be addressed effectively.
5. Regulatory Compliance: Compliance with GDPMD is necessary to align with Malaysian regulations governing medical devices. It also helps ensure that products meet safety and efficacy standards.
6. Training and Competency: Staff involved in the distribution process should receive appropriate training and demonstrate competency in handling medical devices.

Benefits of ISO 13485 and GDPMD

1. Enhanced product quality and safety.
2. Compliance with regulatory requirements.
3. Global market access.
4. Enhanced customer confidence, brand reputation and customer trust.
5. Improved risk management.
6. Operational efficiency with improved processes, reduced waste, and cost savings.