Good Distribution Practices for Medical Devices (GDPMD)
It is announced with pleasure that being the first Pakistani Origin Certification Body has achived another land mark of Accreditation Scope Enhancement by adding GDPMD Accredited Certification notified by Pakistan National Accreditation Council (PNAC), Federal Ministry of Science & Technology.
As per Drug Regulatory Authority of Pakistan (DRAP) Act, 2012 (XXI of 2012), Importers, Exporters, Distributors and Sellers of Medical Devices are required to comply with Good Distribution Practices for Medical Devices (GDPMD) to get registration/license from Drug Regulatory Authority of Pakistan (DRAP) for distribution of Medical Devices in Pakistan.
Good Distribution Practices for Medical Devices (GDPMD) specifies a quality system used for handling, storage, delivery, installation, re-call, service and secondary assembly requirements for Medical Devices.
Good Distribution Practices for Medical Devices (GDPMD) compliance/certification gives confidence to customers that organization complies to legal and regulatory requirements as well as quality is maintained throughout supply chain of Medical Devices to include but not limited to instruments, medical equipment, implants, disposables and software used mainly for the purpose of diagnosis, monitoring and treatment of diseases.
Benefits of GDPMD
- GDPMD ensures compliance to regulatory requirements (DRAP) thus ensuring license to distribute/trade of medical devices
- it reduces risks, time, money and improves performance, product/service quality & customer satisfaction
- requirement for establishment licence for registration with DRAP
- enhance business growth
- supports integration with other management system like ISO 9001, EMS 14001 etc.