Monthly Archives: September 2019

In Indonesia, registrants looking to register a medical device to establish a distribution/marketing license must independently determine the risk class of the device according to the type of product being registered. Medical devices are classified in accordance with the ASEAN Medical Device Directive (AMDD) and the medical device class determines the requirements for registration. The AMDD is a harmonization of medical devices regulations across the ASEAN region and has been incorporated in PERMENKES No. 62 of 2017 concerning the License of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies in Indonesia.

Previously, medical device classification was carried out by the Registrant, then verified/amended by the Evaluator of the Assessment Directorate. An application in which the medical device was incorrectly classified was returned to the registrant for correction. Mistakes in classifying the risk of medical devices can pose risks to the safety of patients. In addition, it can slow down medical licensing services and result in Non-Tax Revenue (PNBP) pricing errors, which can result in state losses due to underpayment. From the registrant’s side, any overpayment cannot be refunded.

Medical device risk classification according to AMDD is not user-friendly and can be difficult to understand. Therefore, to support registrants in determining medical device risk classes independently, the MoH in Indonesia has created a new feature on the registration system wedsite (www.regalkes.kemkes.go.id) known as Sistem Klasifikasi Risiko Alat Kesehatan (SIKLARA). SIKLARA can be found in the information (informasi) menu on the website. SIKLARA is a Medical Device Risk Classification System that aims to identify the risk of medical devices in accordance with the AMDD and has been trialled on the site since mid-2019. The classification of risk of medical devices determines the safety, quality and efficacy of medical devices.

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

SIKLARA is only an electronic general guide that is carried out independently. Information obtained from the results of risk determination using this system does not constitute an absolute decision. The risk classes obtained through this system can be further reviewed by the Assessment Directorate using printable results as proof of self-assessment. The final outcomes of using SIKLARA system are similar to the Health Science Authority’s Risk Classification Analysis Tool. However, this classification system is still not linked to the online registration system, where usually the applicant determines the class based on the category, subcategory and product type of the device. The MoH has not announced when  SIKLARA will be synchronized with the online registration system.

Today, Singapore is home to more than 60 multinational MedTech companies undertaking a range of activities from acting as regional headquarters to manufacturing, research and development. The Asia Medical Technology market is expected to grow at a CAGR of 8% and is projected to overtake the European Union market as the second largest market globally by 2020 and Singapore’s strategic position would enable MedTech companies to tap into these regional opportunities.

Singapore’s strong design and engineering capabilities, the base of automation suppliers and the presence of high-quality assurance standards have helped it to undertake the manufacturing of high-value medical products. With the Smart Nation initiative and the shift towards connected devices, Singapore has been able to offer companies a strong and established base to build new business models around big data and patient-centric care. All these factors have contributed to Singapore being a critical manufacturing base for diverse medical technology products such as implantable pacemakers, contact lenses and life science instruments for global markets.

According to the Economic Development Board, 60% of the world’s microarrays and one third of the world’s thermal cyclers and mass spectrometers are manufactured in Singapore. Many MedTech companies have established their R&D presence in Singapore, with many investing in end-to-end capabilities ranging from product design, to optimisation and validation; many more leading global MedTech companies have established their regional headquarters in Singapore.

Singapore has a focussed innovative R&D ecosystem which helps MedTech companies flourish. Singapore offers a highly skilled workforce from world class universities together with research institutions and innovative start-ups, which enable MedTech companies to tap into a vibrant innovation ecosystem. With a strong presence of more than 25 R&D centres established by multinational MedTech companies and a local pool of over 220 MedTech start-ups and small-medium enterprises, MedTech companies have increasingly been plugging into this network of innovation, talent and ideas to develop next-generation products and solutions for regional and global markets. Singapore, being a hub for marketing, business innovation, regulatory, and e-commerce, is the ideal place to expand access in Asian markets.