This announcement is intended to be used as a guideline and a for distributing medical devices. As well as to ensure medical devices quality, safety and performance including the process throughout the supply chain covering procurement services, transportation and delivery, storage, installation system operation test, service, maintenance, calibration, after-sales service, follow-up on any document management and record keeping.
This announcement is applicable for authorized representatives of foreign manufactures, importers or medical device licensees only. The announcement covers the obligation of GDPMD Organization, Resource management, Supply chain, and Surveillance requirement. Qualtech takes you overview each section.
Organization and GDPMD regulatory compliance system
(1) Organization and Establishment responsibilities: Establishment must arrange to maintain management system that is in accordance with the criteria of Good Distribution Practice for Medical Devices, including the process of identifying and correcting deviations from the management system
(2) Documentation: Establishment must arrange and maintain the documents operating in accordance with the criteria and methods of Good Distribution Practice for Medical Devices.
(3) Document and record control: Establishment must control documents operating in accordance with the criteria and methods of Good Distribution Practice for Medical Devices.
Management review: The highest management shall appoint a representative of the management by determining the authority, duties and responsibilities to ensure that there is a management system that is in accordance with the criteria of Good Distribution Practice for Medical Devices.
(1) Personnel: Establishment must provide personnel with the required competence and sufficient amount to carry out all activities and operations.
(2) Infrastructure: Establishment must define, provide and maintain the basic utilities necessary to achieve in accordance with the requirements by the mentioned implementation.
(3) Cleanliness: Establishment must prepare requirements for cleanliness of the premises including being the responsible person of a document format and keeps a record of cleaning.
(4) Pest control: Establishment must implement the dispose of pests to prevent damage and contaminated with medical devices as well as keeps a record of pest control.
Supply chain and device specific
(1) Authorization: Witten agreement must be made to confirm the authorization.
(2) Communication channels: Establishment must prepare feedback mechanism.
(3) Warehouse and Inventory Management and Delivery to customer: Establishment must conduct audit systems or other activities that are necessary and implemented to ensure that medical device is accepted in accordance to the criteria.
(4) Control of nonconforming medical devices including returned medical devices: Establishment must prepare the operation procedure as a document for handling recall medical device.
(5) Disposal of medical devices: Establishment must prepare procedures for destruction of medical devices in documents format which must comply with the law relevant rules.
(6) Distribution records & Traceability: means documentation of all activities related to medical device distribution which includes receiving, delivering and destroying.
(7) Calibration: means devices or measuring devices used to maintain the condition and distribution of medical device is appropriate and must be calibrated or verifying according to the schedule or before use.
(8) Specific requirements for active medical devices, Installation and Servicing: Establishment must prepare procedure for installation qualification.
(9) Outsource activities: Establishment must ensure that the outsourcing process is controlled under the scope and criteria of Good Distribution Practice for Medical Devices.
(10) Counterfeit adulterate unwholesome and tampered medical devices: Establishment must ensure that any medical device that is found to be forgery, adulteration, misconduct and modifications must be separated from other medical devices.
Practice of surveillance and vigilance
(1) Medical device complaints: Establishment must file documents handling complaints about medical devices and apply them.
(2) Device Defect, Adverse Effect, Field Safety Corrective Action; FSCA and Recall : Establishment must prepare Device Defect & Adverse Effect report.
(3) Internal audit: Establishment must prepare the procedures in document format, which must specify the responsibility, planning, Internal operation and monitoring, reporting and maintaining internal audit records.
(4) Corrective action and Prevention action: Establishment must prepare procedures in document format assigning the appropriate responsible person to handle Corrective action and preventive action.
Translated from official ThaiFDA announcement, by: