In order to ensure the product quality is maintained throughout the supply chain, TMDA conducts GDP inspections for all premises that store, sell, transport and distribute medical devices and diagnostic devices to verify compliance with GDP requirements.
GDP requirements are verified during pre-registration inspections of medical devices and diagnostics premises and during routine inspections. The key requirements for GDP include the following: -
- Availability of structure administrative system,
- Adequate personnel with appropriate and adequate training,
- Proper premises in relation to the activity and product(s),
- Documentation of procedures for receiving of products, storage, dispatch, and transportation, recalled, returned, expired, complaints, substandard and falsified products, and
- Monitoring of the conditions i.e Temperature and Humidity where the product are stored and transported.
To view list of TMDA gazetted GDP inspectors click here.