Malaysia: Control of Orphaned, Obsolete and Discontinued Medical Devices in Hospitals, Healthcare Institutions or Any Related Facilities

Halal

On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical devices in hospitals, healthcare institutions or any related facilities. According to the circular letter, an orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements; however, healthcare facilities that are in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority.

On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical device in hospitals, healthcare institutions or any related facilities.

An orphaned medical device is an existing medical device in a hospital, healthcare institution or any related facility that is not registered under Act 737 as it no longer has the manufacturer or authorized representative to register the medical device. Obsolete medical devices are outdated medical devices that are no longer used due to design changes or the evolution of new technologies etc. Discontinued medical devices are medical devices that are no longer distributed in the market or are no longer being produced.

According to the circular letter,
a) An orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements
b) Establishments or healthcare institutions in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority
c) The risk of using orphaned, obsolete and discontinued medical devices the responsibility of the establishment, users and healthcare institution
d) Establishments shall be responsible for post-market issues associated with any obsolete or discontinued medical device for the projected useful life of the medical device as determined by the manufacturer
e) Compliance is required with notification requirements as specified by the Authority

This circular letter shall be used as part of requirements under Act 737 and shall be effective from the date it is issued. The revised circular letter can be referred to here and the original circular letter released in 2018 can be referred to here.

2019-10-02T04:16:12+08:00 September 28th, 2019|Insight, Medical Regulation Updates, News & Events|

International Medical Device Conference (IMDC) and Malaysia Medical Device Expo (myMEDEX)

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The Medical Device Authority (MDA) in Malaysia is organizing both IMDC and myMEDEX to be hosted at the Malaysia International Trade and Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 15 to 17 October 2019. The target audience for these 3-day events includes regulators, industry representatives, researchers, clinicians and members of academia.

The International Medical Device Conference (IMDC) 2019 and Malaysia Medical Device Expo (myMEDEX) 2019 will be held in Kuala Lumpur, Malaysia this October. The Medical Device Authority (MDA) is organizing both IMDC and myMEDEX to be hosted at the Malaysia International Trade and Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 15th October 2019 (Tuesday) to 17th October 2019 (Thursday). The target audience for these 3-day events includes regulators, industry representatives, researchers, clinicians and members of academia.

The International Medical Device Conference 2019 will provide a forum for medical device regulators, healthcare institutions, healthcare service providers, research institutes, conformity assessment bodies, training bodies, medical device testing laboratories and stakeholders to discuss and share experiences on regulations and quality and safety of medical devices. The purpose of this Forum is to provide a platform for regulators and stakeholders of the medical device industry worldwide to meet and receive updates on current affairs pertaining to the medical device industry.

The Malaysia Medical Device Expo is an initiative by the MDA to highlight the latest innovative technologies and advances of global medical devices. The aim is to create an insightful one-stop center for medical device solutions. The medical device industry is one of the largest industries in global healthcare.

For more information on IMDC 2019, contact the IMDC 2019 secretariat at the following email address: imdc2019@mda.gov.my or on +603 8230 0300.

For more information on myMEDEX 2019, contact the myMEDEX secretariat at the following email address: info@mymedex.com.my or on +603 8070 7666.

2019-10-02T04:13:15+08:00 September 28th, 2019|Event, News & Events|

Indonesia: SIKLARA, the Medical Device Risk Classification System

RAPS

The Ministry of Health (MoH) in Indonesia has introduced a new feature on the registration system website called SIKLARA – a medical device risk classification system aligned with the ASEAN Medical Device Directive (AMDD). SIKLARA has been trialled on the site since mid 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.

2019-10-02T04:09:19+08:00 September 28th, 2019|Event, Insight, News & Events|

Singapore as a Medical Device Technology Sector Hub

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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.

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.

2019-10-02T04:07:56+08:00 September 28th, 2019|Event, Insight, News & Events|