GDPMD Good Distribution Practice for Medical Devices

GDPMD: Good Distribution Practice For Medical Devices

As stated by the Good Distribution Practice for Medical Devices (GDPMD) Malaysia, medical device distributors, importers, and authorised representatives are required to establish, implement, and maintain a quality management system in compliance with the Malaysian Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012.

The primary objective of GDPMD is to ensure the quality, safety, and performance of medical devices. This includes various activities such as transportation and delivery, product sourcing and procurement, storage, installation, commissioning, service and maintenance, calibration, after-sales service, as well as tracking, documentation, and record-keeping practices.

Wholesalers and importers of medical devices in Malaysia must implement and obtain a GDPMD certificate to apply for an establishment license.

GDPMD Good Distribution Practice for Medical Devices 2

Why Become GDPMD Certified in Malaysia?

Ensuring ongoing compliance with GDPMD in Malaysia is paramount for patient safety, quality assurance, supply chain efficiency, and international market acess. Periodic audits are conducted to assess and verify adherence to GDPMD criteria, reinforcing the commitment to maintaining the highest standards in the medical device distribution sector locally.

To find out more about how to apply for GDPMD license in Malaysia or the key requirements of GDPMD, you can refer to our articles. Or contact our ISO consultants and training providers in Malaysia for expert guidance and updates on compliance practices.

Who Needs GDPMD Certification in Malaysia?

GDPMD certification is essential for various entities involved in the distribution and handling of medical devices in Malaysia. Here's a brief overview of who should obtain this certification:

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Medical Device Distributors

Companies distributing medical devices must obtain GDPMD certification to comply with Malaysian regulations and ensure product safety.

Importers

 Importers of medical devices into Malaysia require GDPMD certification to meet legal standards and facilitate smooth customs processes.

Wholesalers

Wholesalers handling medical devices in Malaysia need GDPMD certification to guarantee quality and adherence to distribution guidelines.

Manufacturers

Manufacturers of medical devices seeking to distribute their products in Malaysia must obtain GDPMD certification to demonstrate compliance and quality.

Retailers

Retailers selling medical devices in Malaysia benefit from GDPMD certification to assure customers of the products' safety and quality standards.

Healthcare Providers

Healthcare providers involved in distributing medical devices need GDPMD certification to ensure their products meet regulatory requirements and safety standards.

Benefits of Obtaining GDPMD Certification in Malaysia

Regulatory
Compliance

GDPMD certification ensures adherence to Malaysian regulations for medical devices, helping you avoid legal issues and penalties.

Enhanced
Market Access

Being GDPMD certified opens doors to more business opportunities within Malaysia’s medical device market, expanding your customer base.

Increased Consumer
Confidence

Certification signals to customers that your products meet high safety and quality standards, boosting trust and credibility.

Improved Operational
Efficiency

GDPMD standards promote streamlined processes and better management practices, leading to increased efficiency in operations.

Risk
Management

Implementing GDPMD guidelines helps in identifying and mitigating risks associated with medical devices, ensuring safer product distribution.

Competitive
Advantage

GDPMD certification distinguishes your business from competitors, providing a clear edge in the Malaysian medical device industry.

Steps To Certification

With a good understanding and the right preparation  of what is required for the GDPMD requirement and MDA regulations,  most organisations can achieve certification within 3 to 6 months depending on the medical device (category) they supply.

  • 1Request for Quotation

    Call us now and select a package that fits your budget.

  • 2Make Appointment with Our Consultant

    Receive your first-round free consultation

  • 3Introduction to GDPMD Training

    Help your organization to demonstrate commitment towards quality and customer satisfaction.

  • 4Documents Preparation & Implementation

    Identify documents that are needed for your Quality System and Production or Service Processes; start to implement.

  • 5Internal & External Audit

    To confirm that your Management System (QMS) is properly established and maintained while meeting the international standard.

  • 6Get Certified & Impress Your Client

    Show off your certificate on your website and sales collateral.
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Frequently Asked Questions

What is GDPMD?
A crucial component of the integrated supply chain for medical devices is distribution. To assure the performance and safety of medical devices at the point of use, a variety of people and entities are generally in charge of the transportation, storage, installation, product sourcing, procurement, delivery, device tracking, commissioning, servicing, and maintenance. Although, there are cases where an individual or organisation is only accountable for and active in a small portion of the distribution process. The dangers involved with these activities could be on the level with others in the manufacturing environment, and the lack of control over them could impact the devices' performance and safety. The Good Distribution Practice for Medical Devices (GDPMD) was developed to clarify the requirements for adequate administration and management of these operations.
To comply with Malaysian medical device regulatory requirements as outlined in the Medical Device Act 2012 (Act 737), GDPMD details the requirements for a quality management system to be established, implemented, and maintained by an establishment when carrying out activities in the medical device supply chain.
OR
According to the Medical Devices Act of 2012 (Act 737), all businesses engaged in activities are subject to the Good Distribution Practice for Medical Devices (GDPMD). The medical device supply chain companies must create, implement, and keep up a quality management system.
The accreditation confirms a facility's capability to maintain the performance, safety, and quality of medical equipment under its care. Representatives of international medical device producers, importers, and distributors in Malaysia are included in the standard.
Who does GDPMD apply to?
GDPMD applies to the organization that wishes to trade and supply medical devices in Malaysia.
What benefits will GDPMD Malaysia certification bring to my business?
GDPMD Malaysia certification enhances your credibility, ensures compliance with local regulations, and improves your market competitiveness by demonstrating a commitment to quality and safety in medical device distribution.
Should I get GDPMD Malaysia certified?
If you're involved in the distribution, import, or handling of medical devices in Malaysia, GDPMD certification is crucial. It ensures that your operations meet regulatory standards, boosting trust with clients and regulatory bodies.
How long is the GDPMD certification process?
The GDPMD certification process typically takes a few months, including preparation, documentation, and audit phases. The exact duration can vary based on your current compliance status and readiness.
What is the cost of GDPMD Malaysia certification?
The cost of GDPMD Malaysia certification varies depending on the size of your business, the scope of certification, and the consultancy fees. Contact us for a detailed quotation tailored to your needs.

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