WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (WHO SAGE IVD)

The World Health Organization (WHO) has established a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body to matters of global policies and strategies related to in vitro diagnostics (IVDs). The SAGE IVD is expected to meet annually to make recommendations on the content, format, and implementation of the WHO Model List of Essential In Vitro Diagnostics (EDL) and on any matters related to IVDs. The EDL is intended to provide evidence-based guidance and set a reference for the development or update of national lists of essential in vitro diagnostic tests.

This event shares the report which lists 122 in vitro diagnostic (IVDs) categories and incorporates evidence base and expositions of the applications to be included on the EDL and the basis of decisions made to list or reject these IVDs.

Asia Harmonization Working Party (AHWP)

After consolidating the comments received from AHWP members, the following proposed final documents have been endorsed at 24th AHWP Meeting in Muscat, Oman held on 11 to 14 November 2019:

  • Challenges and Recommendations for the Implementation of a Globally Coordinated UDI system

  • Competency Framework for Medical Technology Regulators

  • Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)

  • Categorization of Changes to a Registered Medical Device

The technical committee meeting will take place in March in Singapore, and the next annual AHWP meeting will be the election of the next AHWP committee.

APACMed Medtech Forum

The Asia Pacific MedTech Forum 2019 returns for its 5th edition, under the theme 'Connecting Leaders, Connecting Care'. Hosted by the Asia Pacific Medical Technology Association, the event was held from 7 to 9 October 2019 in Singapore with an audience of more than 1,000 delegates from over 30 countries.

During the forum, APACMed launched the first-of-its-kind Connected Care showcase, featuring products and innovations from leading industry brands as well as start-ups and disruptors, and celebrated the inaugural MedTech Innovator Asia Pacific competition which saw more than 170 applicants from 35 countries compete across the region.

Malaysia IMDC conference and myMEDEX expo

The International Medical Device Conference (IMDC) and Malaysia Medical Device Expo (myMEDEX) were held in Kuala Lumpur, Malaysia from 15 to 17 October 2019.

The Prime minister of Malaysia, Tun Dr. Mahathir and the Minister of Health, Datuk Seri Dr. Dzulkefly Ahmad grace the event with the opening ceremony and visit to the myMEDEX expo. Tun Dr. Mahathir stated that Malaysia is the world’s largest producer and leading exporter of rubber products, contributing 63% of the global supply while the export revenue was projected to reach a total of RM19 billion in 2019.

The following key topics were shared at IMDC:

  • Industry Discussion & FAQ led by Mr Ahmad Sharif bin Hambali (MDA)

  • AMDD and Centre of Regulatory Excellent by Mdm Sasikala Devi Thangavelu (MDA)

  • Asian Harmonization on Medical Device, by Ms Tran Quan (AHWP & Invisalign)

  • Top Global Research Trends in Medical Devices by Dr. Eng. Nazeeh Shuja Alothmany (WHO)

  • Challenges of the new EU MDR by Mr Thomas Stefan Brand (B. Braun)

  • Delivery Clinical Research within Speed, Reliability and Quality, by Dr Akhmal Yusof (CRM)

  • Health Technology Assessment, by Mr Eric Woo (ECRI)

  • Accelerating Innovation Across healthcare & Capacity building, by Mdm Yasha Huang (APACMed)

  • Robotic in Healthcare: Trends and Possibilities by Dr Ogan Gurel (DGIDT & FRT)

  • Research to Commercialization and Competition led by Ms May Ng (ARQon)

MEDICA Dusseldorf

Some 5500 exhibitors at MEDICA and nearly 800 at COMPAMED ensured a new record in participation. Two-thirds of the visitors came from abroad, representing some 170 countries. Numerous delegations with senior decision-makers from regions including Asia (such as Thailand’s Deputy Prime Minister and Trade Minister Jurin Laksanawisit), North Africa and South America contributed to this high degree of internationality, which very much accommodates the export interests of many suppliers.

It is also ARQon privilege to be interviewed at the MEDICA by Mr Monir El Azzouzi, from Easymedicaldevice and the well-known medical device blogger, on the topic related to Regulatory overview to penetrate Asia market.

ARQon Regulatory overview and penetrating Asia market, interview video here.

Source: Website of WHO, AHWP, APACMed, IMDC, myMEDEX, MEDICA

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