The Good Distribution Practice for Medical Devices (GDPMDS) is a mandatory audit for any organizations involved with importing, wholesale and distribution of medical devices prior to their license application. Certification against GDPMDS qualifies that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification.
In an effort to provide such assurance, organizations will require more than a few quality manuals. Organization needs to include appropriate procedures, suitably qualified personnel, correct processes / facilities / equipment as well as clear and timely documentation, to credibly demonstrate the consistency of quality assurance.
Organizations certified to ISO 13485 will not need to apply for GDPMDS and will find that they have partially fulfilled the GDPMDS requirements. You may want to visit the HSA website to find out more on the difference between GDPMDS and the other standards; and organizations will need to fill the gap before they can be considered compliant.