GDPMD

Medical-device

GDPMD (Good Distribution Practices for Medical Devices):

GDPMD (Good Distribution Practices for Medical Devices) determines the necessities for a Quality Management System to be set up, carried out, and kept up with by an association in doing exercises in clinical gadgets dispersion to follow the clinical gadget administrative prerequisites.

GDPMD (Good Distribution Practices for Medical Devices) requires an association to show its capacity to keep up with the quality, security, and execution of clinical gadgets in consistence with the clinical gadget administrative prerequisites during dissemination.

With the viable date (1 July 2013) of Act 737 and Medical Device Regulations 2012, makers and merchants of clinical gadgets are needed to apply for their foundation permit to keep doing their assembling, conveyance, or bringing in exercises.

Producers require ISO13485 Medical Devices Quality Management System certificate while Distributors, Importers, and neighborhood Authorized Representative to require Good Distribution Practice for Medical Devices (GDPMD) accreditation before applying for their Establishment License.

Benefits of GDPMD

  • Savings in cost from the 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 continuous improvement processes.