GDPMD - GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES

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 and Importers require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment Licence.
There is a transition period of two years and one year respectively for the industry to submit applications for medical devices product registration and establishment licensing before the law is fully enforced, as provided in Section 80, Act 737. (source: www.mdb.gov.my)
The GDPMD requirements consists of 6 parts:

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 Certification

1. Savings in cost from reduction of defects and rejects
2. Meet regulatory requirements and customer expectations
3. Consistency to proper storage, handling, distribution and traceability
4. Demonstrate ability to produce safer and more effective medical devices
5. Improve operation efficiency through continual improvement processes

SQC Management PG provides management system 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
   1. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
   2. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body

Our customised in-house training services include

1. GDPMD Awareness
2. Understanding, Documenting and Implementing GDPMD
3. Internal Audit of GDPMD

Timelines

Below are the key dates to remember

Highlights

• Regulation becoming operational
  1st July 2013
  
• Establishment Licence
  Before 1st July 2014 (hence need to obtain GDPMD certificate before this date)
• Product Registration
  Before 1st July 2015

Need Advice?

Contact Mr. Eddick at 012 - 405 9003 or email to him at eddick.sqc@gmail.com
for more information pertaining to GDPMD and get a free assessment on your current situation.