The MoH in Indonesia has released SIKLARA- a medical device risk classification system that lines up with AMDD. This system aims to be more user friendly, as well as support registrants in determining medical device risk classes.

Indonesia’s Device Risk Classification System: Overview 

In order to register a medical device and establish a distribution/marketing license in Indonesia, registrants must independently determine the risk class of the device based on the type of product being registered. The risk classification is determined based on guidelines set by the ASEAN Medical Device Directive (AMDD), a harmonization of regulations across the ASEAN region, and can be very difficult for registrants to understand. This makes the registration process long and tedious, slowing down medical licensing services and resulting in Non-Tax Revenue pricing errors that cause state losses.

 

 

What is SIKLARA? 

SIKLARA stands for Sistem Klasifikasi Risiko Alat Kesehatan, which translates to, “Medical Device Risk Classification System,” in English. This is a new feature developed by the Ministry of Health (MoH) on the Indonesian registration system website that serves as a new risk classification tool for medical devices in Indonesia. It acts as an electronic general guide that is used independently by registrants and aligns with AMDD standards. The purpose of SIKLARA is to give registrants some guidance in determining medical device risk class, to eliminate user error, and reduce time to market in Indonesia. SIKLARA has been tested on the website since mid-2019, and has since helped registrants be more effective in determining the risk class of the medical device in question. 

Main features of SIKLARA include: 

  • Home (Beranda)
  • Guidelines (Pedoman)
  • Classification Guidelines (Pedoman Klasifikasi)
  • Classification Scheme (Skema Klasifikasi)
  • MoH regulation no. 62 of 2017 (PERMENKES 62 tahun 2017)
  • AMDD 
  • Classification (Klasifikasi)

 

 

What does this program mean for Indonesia? 

The process of classifying a medical device in any country is long and tedious. In the past, registrants for Indonesia had to carry out this process on their own and have their classification verified by the Evaluator of the Assessment Directorate. In this case, if a device was classified incorrectly, the application would be returned to the registrant and they would have to complete the whole process again. This is costly and can slow down medical licensing services, overall increasing time to bring medical devices to market. With SIKLARA, the process is becoming much more user-friendly and easier to understand. It aims to support registrants in determining the class of their device and help them interpret and follow the ASEAN Medical Device Directive. SIKLARA is still being developed and primarily functions as a supplementary tool for classification, but is already making changes in the world of regulatory approval. 

 

 

How RegDesk Can Help

RegDesk platform provides medical device manufacturers with reliable and detailed information on changes to the most important regulations in a timely manner. The information provided is necessary to comply with applicable rules and regulations in the sphere of manufacturing, importation, distribution and post-marketing maintenance of medical devices.

 

Source:

SIKLARA, the Medical Device Risk Classification System

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