• RoundupsRoundups

    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
  • RoundupsRoundups

    Asia-Pacific Roundup: Singapore seeks feedback on planned unique device identification system

    Singapore’s Health Sciences Authority (HSA) is seeking feedback on the regulatory requirements for the planned implementation of a unique device identification (UDI) system. HSA wants to establish a harmonized identification system to enable the traceability of medical devices.   Today, HSA lacks the means to track the distribution and use of medical devices across the supply chain and healthcare system. HSA wants to gain that power to support the timely identification...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...
  • Regulatory NewsRegulatory News

    Updated Again: FDA to Pull Singapore Device Firm From Import Alert List

    A subsidiary of Biosensors International, a group of companies developing, manufacturing and marketing medical devices for cardiology and critical care procedures, failed to respond to an inspection request from the US Food and Drug Administration (FDA) and its products were banned from entering the US. However, five days after the company's name was posted on the import alert list, a Biosensors spokesman told  Focus  that the company will be removed from the list aft...
  • RAPS' LatestRAPS' Latest

    RAPS-National University of Singapore Certificate Program Celebrates First Graduating Class

    The Medical Device Regulatory Affairs (MDRA) Graduate Certificate Program , a joint academic program from RAPS and the School of Biomedical Engineering at the National University of Singapore (NUS), graduated its first cohort of 31 students last month. The program was developed in partnership with several of Singapore’s government agencies as part of the country’s efforts to nurture a highly competent regulatory workforce. Singapore has spent much of the past de...
  • Regulatory NewsRegulatory News

    Dr. Khoo Teng Chuan, Co-Chair of the RAPS Pan Asia Advisory Committee, Dies at 56

    Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56. Most recently, Dr. Khoo worked as chief medical officer for the Singapore Clinical Research Institute, after joining the institute as senior vice president in 2010. In this role as chief medical officer, he worked closely with Singapore’s national agencies including the National Medical Research Council, Health Sciences Aut...
  • RAPS' LatestRAPS' Latest

    RAPS, National University of Singapore Gear up for 2nd Year of Certificate Program

    Last year, RAPS and the National University of Singapore (NUS) launched a joint graduate certificate program in Medical Devices Regulatory Affairs (MDRA) for Singapore-based regulatory professionals. The program was developed in partnership with Singapore’s government as part of its effort to help cultivate the highly competent regulatory workforce needed to support the country’s growing medical technology industry. The first year of the MDRA certificate program ...
  • Regulatory NewsRegulatory News

    Singapore Regulator Alleges Fake Lab Report Used on Facebook Page

    Singapore’s healthcare product regulator, the Health Sciences Authority (HSA), is alleging that a Malaysian dietary supplement company used falsified lab reports when promoting one of its products on its Facebook page and blog. A Warning on Facebook The company, Champion Club International Sdn Bhd, was warned about the Facebook post by HSA in a 23 December 2014 update on the regulator's website . The update clarifies that the product in question, known as "E250," is ...
  • Feature ArticlesFeature Articles

    The Southeast Asian Regulatory Environment for Pharmaceuticals (Part 1)

    This two-part series on the Southeast Asian regulatory environment for pharmaceuticals describes the regulatory landscape in each of the 10 Association of Southeast Asian Nations (ASEAN) countries and attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets. Part 1 presents information on the larger ASEAN markets of Singapore, Malaysia, Thailand, the Philippines and Indonesia. Part 2 will discuss Brunei, Vietna...
  • Feature ArticlesFeature Articles

    Singapore’s GDPMDS versus ISO 13485:2003: A Comparative Analysis

    Good Distribution Practice (GDP) is a term first officially coined in the European Community Council Directive 92/25/EEC for medicinal products, and it is a subject that has been covered in guidelines by most major reference authorities. 1 In most of these cases, GDP is generally considered an extension of Good Manufacturing Practices (GMP). In US regulations and US Food and Drug Administration (FDA) guidelines, for example, there are no separate regulations or gu...