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Good Distribution Practices for Medical Devices

What is ISO GDPMD ?

Since the effective date of Act 737 and Medical Device Regulations 2012 on 1st July 2013, manufacturers and distributors of medical devices must obtain the necessary licenses to continue their manufacturing, distribution, or importing activities. Manufacturers need to obtain ISO 13485 Medical Devices Quality Management System certification, while Distributors, Importers, and local Authorized Representatives must obtain Good Distribution Practice for Medical Devices (GDPMD) certification before applying for their Establishment License.

Requirements of GDPMD ?

  1. Preliminary

  2. Organization and GDPMD Regulatory Compliance System

  3. Establishment Responsibilities

  4. Resource Management

  5. Supply Chain and Device Specific

  6. Surveillance and Vigilance

Benefits of GDPMD

  • Demonstrate the ability to produce safer and more effective medical devices

  • Meet regulatory requirements and customer expectations

  • Ensure consistency in proper storage, handling, distribution, and traceability

  • Achieve cost savings by reducing defects and rejects

  • Enhance operational efficiency through continual improvement processes

How can Nixan assist you?

At Nixan, we specialize in providing management system training and consultancy services. With our extensive expertise and practical experience, we assist clients in developing effective management systems, from conceptualization to successful implementation.

 

Our consultation approach is designed to help you achieve certification by following these key steps:

01

Identify areas within your current Management System that require improvement or development.

02

Collaborate with your company personnel to create a strategic action plan that addresses these improvement areas and effectively communicates the requirements to key personnel at all levels.

03

Deliver system-related trainings to your company personnel, raising awareness and equipping them with the necessary knowledge and skills for system implementation.

04

Help and guidance in developing and implementing the systems, including the preparation of documentation.

05

Offer advice and support, if needed, in preparing and submitting applications to your certification body.

06

Assist in the development of internal auditing procedures and provide training to ensure effective implementation of the management system.

07

Conduct internal audits to verify the successful implementation of the management system prior to the final audit by your certification body.

08

Facilitate Management Review Meetings to evaluate the performance of the management system and identify areas for improvement prior to the final audit by your certification body.

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