In order to guarantee that medical devices and household health supplies meet quality, safety and efficacy requirements, products must obtain a marketing authorization number. This is evaluated by the Directorate of Assessment, Indonesia prior to product distribution
Based upon the Ministry of Health (MoH) regulatory PERMENKES No. 64 of 2015 (concerning the Organization and Work Procedures of the MoH), the Directorate of Production and Distribution of Medical Devices is divided into two directorates:
1. Directorate of Assessment of Medical Device and Household Health Supplies;
2. Directorate of Surveillance of Medical Device and Household Health Supplies
After a product receives a marketing authorization number from the Directorate of Assessment, it can be distributed. At this stage, it is the task of the Directorate of Surveillance to provide supervision of the distributed product. The purpose of supervision is to ensure that medical devices and household health supplies meet the appropriate standards and/or requirements, thereby preventing and controlling any potential consequences that arise from misuse and abuse. This also provides legal certainty, creates a healthy business climate and furthermore, protects the public from the dangers of using medical devices and household health supplies that do not meet the quality, safety and efficacy requirements.
The activities conducted by the Directorate of Surveillance to achieve the aforementioned purposes are listed below:
1. Sampling and Testing
Sampling and testing are conducted by MoH Surveillance when a product is widely used by the public or, when a product has experienced an adverse event. These aim to protect the public from using products that do not meet quality and safety requirements and to ensure product consistency. It also serves as a way to detect the presence of fake or illegal products.
2. Advertising and Labelling Control
Supervision of advertising and labelling are conducted with the aim of protecting the public from misleading information, avoiding dangers/adverse effects, preventing harm to the environment, and preventing material and immaterial losses due to improper use. Advertising and labelling are required to be objective, ethical and should not use misleading information or language that can be open to interpretation.
3. Vigilance System Supervision
Vigilance System Supervision is part of the Medical Device Supervision with the aim of preventing the recurrence of the same event and to correct any unexpected event. An unexpected event can still occur with products despite passing the assessment stage. An unexpected event is defined as one in which serious injury, death or deterioration in the health of patients, users or others is caused directly or indirectly by a product defect (damage or failure, decreased performance, or inadequate marking or instructions for use). Events can be reported by distributors, health service facilities, and the public/patients users of the product.
4. Clinical and Technical Information Audit
This activity is also included in the role of MoH Directorate Surveillance.