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 licence 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 Licence.

 

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

 

• Savings in cost from reduction of defects and rejects

• Meet regulatory requirements and customer expectations

• Consistency to proper storage, handling, distribution and traceability

• Demonstrate ability to produce safer and more effective medical devices

• Improve operation efficiency through continual improvement processes

 

ELITE provides GDPMD training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.

We use the following consultation approach to assist you in achieving certification:

1. Identify areas requiring improvement or development within your current Management System

2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels

3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems

4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation

5. Advise and assist, if required, with the preparation and submission of applications to your certification body

6. Assist with the development of internal auditing procedures and training

7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body

8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body