Indonesian Ministry of Health (MOH) according to the Minister of Health Decree No1196 Menkes Per X 2010 specifies the classification and registration procedures for medical devices. Medical devices are typically classified based on their intended use, performance characteristics, and degree of danger. The following are the general steps for how MOH Indonesia determines the classification of medical devices:
Determine the intended use of the productFirst, MOH considers the intended use of the medical device, i.e., what purpose the product is designed and manufactured for. Based on the intended use, MOH classifies medical devices into different categories, such as clinical diagnostic equipment, surgical instruments, dental equipment, monitoring equipment, etc.
Consider performance characteristicsMOH also considers the performance characteristics of a medical device, including its design, function, method of operation, and how it interacts with the patient or user. These performance characteristics can help MOH further subdivide medical devices into different subcategories.
Assess the degree of riskMOH assesses the degree of danger of a medical device, including its potential hazards to patients, users, and third parties. High-hazard medical devices may require greater regulation and scrutiny.
Refer to international standardsMOH will often refer to international medical device classification standards, such as ISO 10993 (biocompatibility assessment) and ISO 13485 (quality management systems for medical devices), to determine the appropriate classification.
Determine the category of medical devicesBased on the above considerations, MOH divides medical devices into different classifications, which are usually divided into four main categories: Class A, Class B, Class C, and Class D. Class A generally includes low-hazard medical devices, while Class D includes high-hazard medical devices.
Registration ProcedureEach medical device category has different registration procedures and requirements. The MOH sets out the registration process for each category, including the required documentation, inspection and review procedures, etc. **Vendors are required to comply with the applicable registration procedures in order to obtain a medical device registration certificate.
It is important to note that the classification and registration procedures for medical devices at MOH in Indonesia may be adjusted depending on the timing and policy changes. Therefore, medical device vendors should carefully study the latest regulations and requirements before applying for registration to ensure that their products are registered according to the correct classification.
In summary, the classification of medical devices determined by the MOH in Indonesia is usually based on the intended use, performance characteristics, and degree of danger of the product. These classifications determine the registration procedures and requirements for medical devices, helping to ensure the safety and compliance of medical devices in the marketplace. Medical device manufacturers** should be aware of and comply with MOH regulations in order to successfully register their products.