GDPMD (Good Distribution Practices for Medical Devices) specifies the requirements for a Quality Management System to be established, implemented and maintained by an organization in carrying out activities in medical devices distribution to comply with the medical device regulatory requirements.
GDPMD (Good Distribution Practices for Medical Devices) requires an organization to demonstrate its ability to maintain quality, safety, and performance of medical devices in compliance with the medical device regulatory requirements during distribution.
The aim of GDPMDS is to ensure that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality of the medical devices is maintained throughout the storage and distribution process. The certification to GDPMDS is a mandatory requirement in the application of an Importer’s or Wholesaler’s License.
Although some of the requirements of GDPMDS are similar to ISO 9001:2000 requirements, the scope of ISO 9001:2000 is not sufficient to meet the requirements for GDPMDS. Companies that are certified to ISO 9001 by one of the accredited certification bodies may arrange with the certification body to expand the next ISO 9001 audit to meet GDPMDS requirements.