Directorate of Assessment Indonesia is providing an assurance for medical devices and household health supplies distributed.
Before products enter the market for distribution all medical devices and household health supplies must attain a marketing authorization number.
This is to ensure that the product quality, safety and efficacy requirements are met. Additionally, providing legal certainty and a healthy business environment. Alongside providing public assurance in the products they use.
This initiative would be done in 4 simple steps.
Step 1: Product Testing
Tests would be done to the product to identify and check for quality and safety requirements and to ensure product consistency and also detect the presence of fake or illegal products.
Step 2: Label Controls
To prevent misleading information from being included. Also ensure that advertising and labeling are objectives, ethical and not include any misleading information or language.
Step 3: Vigilance System Supervision
To prevent the recurrence of the same event and to correct any unexpected event which can potentially still occur even the product has passed its assessment. Such as serious injury, death or deterioration in the health of the patient.
Step 4: Clinical and Technical Information Audit
This activity is under the MoH Directorate Surveillance roles & duties.