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There will also be a law enforcement regulation that will soon apply to distribute medical devices. The company has invited the Quality Service and Administration Division, the Thailand Institute of Scientific and Technology Research (TISTR) and Medical Devices Control Division, the Food and Drug Administration (FDA) to create the opportunities for Improvement (OFI) and to assess and to prepare for the certification.

There are auditors, consultant, and observer of the two institutes has assessed comprised:

1. Explore medical devices storage (Infrastructure, Cleanliness, Pest Control).
2. Organization Chart, Establishment Responsibilities.
3. Designated Person, Management Review, Review Input, and Review Output.
4. Internal Audit, Corrective Action, and Preventive Action.
5. Specific Requirement for Active Medical Devices, Installation and Servicing, Outsource Activities, Counterfeit Adulterate Unwholesome, and Tempered Medical Devices.
6. Authorization, Communication Channels.
7. Calibration.
8. Personnel, Training, Competency, and Awareness.
9. Documentation, Document Control.
10. Receipt of Stock, Storage, Stock Rotation, Delivery to Customer.
11. Traceability, Distribution Records.
12. Medical Devices Complaints.
13. Control of Nonconforming Medical Devices Including Returned Medical Devices.
14. Disposal of Medical Devices and.
15. Field Safety Corrective Action: FSCA, Recall, Device Defect, Adverse Effect.

The assessment spending the full day of 20 April 2018, Summary of the results: The company has a minor defect level. This can be modified and improved manually. The company has the potential to apply for certification in accordance with the guidelines and procedures for distributing medical devices. To ensure that the next.