Ensure quality of medical devices using Good Distribution Practices
Good Distribution Practice (GDP) is part of quality assurance which ensures products are consistently stored, transported and handled under suitable condition as required by the marketing authorisations or product specifications. Wholesalers or importers of medical devices in Singapore are required to attain GDPMDS certification and audits before applying for the licence.
This certification helps to ensure that wholesalers or importers possess the necessary quality management systems, procedures and facilities to handle medical devices, ensuring that they are appropriately stored, transported and handled.
TÜV SÜD’s GDPMDS services involve the entire range of auditing, testing and certification, as well as training solutions that assist our customers in complying with GDPMDS, or other local / international regulations, such as;
- ISO 13485 Quality Management System for Medical Devices
- ISO 14971 Risk Management Requirements for Medical Devices
- ISO 15378 QMS for Medicinal Packaging Materials Suppliers
- ISO 10993-1 Biocompatibility Testing
- Pharmaceutical Testing
- Medical Devices Directive 93/42/EEC
- IEC 60601-1
- IEC 62304