THE STUDY OF THE IMPACT ENFORCEMENT ON GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES AND REGULATORY DEVELOPMENT IN THAILAND

Abstract

The Principle of Good Distribution Practice for Medical Devices (GDPMD) was included in the handling, storage, delivery, installation and service to provide users or consumers with quality, efficiency and safety of medical devices. The objectives of this research were to study the impact enforcement on Good Distribution Practice for Medical Devices in Thailand and review draft of Good Distribution Practice for Medical Devices. The sample of medical device companies was selected using purposive sampling method and tools used in the study were questionnaire and gap analysis report. The study was conducted with 32 companies by onsite visits and 111 companies by using a questionnaire. The result was found that the companies had been accredited with quality management system or had quality system experiences which were capable to apply Good Distribution Practice for Medical Devices in their organizations. The percentage of companies regarding to requirements of Good Distribution Practice for Medical Devices in appropriated level was 61%. The Percentage of readiness about ability to apply Good Distribution Practice for Medical Devices in intermediate level was 47%, high level was 14%, no capability was 38% and no opinion was 1%. Most companies had a opinion that if Good Distribution Practice for Medical Devices was implemented in B.E. 2018, there should be a transition period for 3 years and they required the training, consultant and budget that be provided by the Food and Drug Administration including revised requirements to be applicable. Therefore, the Food and Drug Administration should have roadmap to enforce Good Distribution Practice for Medical Devices and the regulatory would benefit to customers as well as health professionals. Capacity building for companies, audit agencies and regulators was essential to achieving Good Distribution Practice for Medical Devices enforcement.