GDPMD for Medical Devices
WHAT IS GDPMD?
GDPMD specifies the requirements for a quality management system to be established, implemented, and maintained by an established of medical device importer/distributor/ authorized representative to comply with the Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. The objective of GDPMD is to ensure the quality, safety, and performance of the medical device which includes but is not limited to product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration, and after-sales service; tracking, documentation, and record-keeping practices.
The aim of GDPMD is to ensure that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality of the medical devices is maintained throughout the storage and distribution process. The certification to GDPMDS is a mandatory requirement in the application of an Importer's or Wholesaler's License.
Why do you need to implement and certify GDPMD?
1) A license to trade in the logistics and shipping of medical devices
2) Develop a consistent product or service quality, efficiency, and cost benefits
BENEFITS:
- Medical devices are appropriately managed and controlled throughout the supply chain thus ensuring their safety and performance at the point of use.
- Provides assurance to stakeholders through certification that the organization is able to maintain the quality, safety, and performance of medical devices while under its custody.
- Fulfillment of establishment licensing requirements.
The Certification Process
Online gap analysis allows us to see the current
- quality benchmark within your organization,
- the finances required
- the time required for this project (System and Certification Fee)
Your Estimate will be shared with you in 24 hours.
Upon Estimate Approval the project starts:
- A client executive is assigned to your project
- Contact information is shared with you
- The Payment details are provided to you
All Support is delivered Online.
The Client Executive will provide the Documentation Templates and explain to you how to amend it.
You will be required to perform the following tasks:
- Identify your core or business processes.
- Amend documentation that meets your business needs. (Policy statements, objectives, manuals, work instructions, job descriptions, forms.)
- Encourage employees to be aware of the new documented system
- Review, approve, and distribute the documents to those who need access to the information.
- Ensure procedures are being performed as documented.
- Ensure employees are trained properly for the tasks they are performing.
- Create effective reporting systems.
- Monitor the effectiveness of your processes through the use of measurable data, where possible.
- Review and take action to improve in the areas required.
- Plan internal auditing activities.
- Submit your management system documentation for review to ensure it complies with the applicable standard.
- Prepare for review by an external auditor to confirm that the system’s requirements are being satisfied and that the management system is implemented effectively.
- Obtain ISO Certifcaiton
- This periodic on-site review is usually conducted annually.
- It ensures that the certified business continues to comply with Standard requirements, as confirmed during the Recertification Audit at the certification cycle's outset.
- Most are conducted remotely.
Refer to learn more about Types of Audits
