Home About Qualtech NEWS INDONESIA: SIKLARA, Indonesia Medical Device Risk Classification System - July, 2019
INDONESIA: SIKLARA, Indonesia Medical Device Risk Classification System - July, 2019

July 15, 2019

In connection with the registration process of medical devices in Indonesia, where at the initial step Applicants is required to determine the risk classification of medical devices independently, MoH found out that still many applicants determine the class of medical devices incorrectly. The factors include:

1.   Applicant does not have enough knowledge about the device being to be registered.

2.   The complexity of the medical devices that are being registered.

3.   Complexity of the system to determine classification of health devices which is not user friendly and is not easy to understand.

While doing classification incorrectly may resulting in several issues such as: affect a risk of patient safety, excess government payment due to applicant choose higher classification that it should be, and will slow down the licensing time of medical devices.

Based on the description above, MOH made a new feature on the MOH website namely SIKLARA (Sistem Klasifikasi Resiko Alat Kesehatan) which is in English, Medical Device Risk Classification system. This feature aims to facilitate applicants in classifying medical devices and minimalize errors in class determination.

SIKLARA can be accessed via a computer or smartphone. The ways to access SIKLARA are as follows:

1.   Open www.Regalkes.depkes.go.id.

2.   On the information menu, click SIKLARA.

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3.    Once clicked, the SIKLARA page will appear as follows:

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The features of SIKLARA include:

         Beranda (Home)

         Pedoman (Guidance)

         Pedoman Klasifikasi (Classification Guidance)

         Skema Klasifikasi (Scheme of Classification)

         Permenkes (Ministry of Health Regulation)

         AMDD

         Klasifikasi (Classification)

4.    Click Classification Menu, and Classification page will be appeared. Fill up the product name and intended use and click Next.

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5.    After that, on the next page, select a type of health tool, a General Medical Device or an In Vitro Diagnostic Medical Device.

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6.   Start to answer according to the question.

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7.   After completing answering questions on the system, the system will issue the classification results. The results that will appear are Class, Rule and Sample Device.

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In addition, the applicant can also see and print a summary of questions and answers, where the Printable Results can be used as proof of self assessment and can be consulted with the Directorate of Medical Device Assessment because this medical risk classification system is only an electronic guide that is carried out independently and information obtained from the results of determining the risk of using this system is not an absolute decision.

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The final outcome of using SIKLARA system, similar to HSA's Risk Classification Analysis Tool

 

However, this classification system is still not linked to online registration system, where usually the applicant determine the class based on the category, sub category and product type of the devices which follow US FDA. MoH hasn’t mentioned the target on when to synchronize SIKLARA with online registration system yet.

 

Reference:

1.         MedicalDeviceRiskClassificationSystem

2.         SIKLARA

 

Tags:

Indonesia Medical Device Risk Classification System, Classification Tools, SIKLARA

 

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Home About Qualtech NEWS INDONESIA: SIKLARA, Indonesia Medical Device Risk Classification System - July, 2019