The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News
    TrackersTrackers

    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: AHWP to Harmonize Device Submissions in Asia (10 November 2015)

    AHWP Releases Guidance on Harmonizing Medical Device Submissions in Asia The Asian Harmonization Working Party (AHWP) has posted guidance on the preparation of a common submission dossier template for the region. AHWP views the guidance as a step toward eliminating the need for medical device manufacturers to create individually formatted dossiers for submission in China, India and its other member countries. As it stands, companies pursuing the approval of medical de...
  • Regulatory NewsRegulatory News

    AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach

    The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software. The draft version of the document was released in July 2014, and provided a high-level overview of the regulatory approaches taken by major economies--the US, EU, Australia and China—toward the regulation of software as a medical device (SaMD). The overall goal of the white pa...
  • Regulatory NewsRegulatory News

    AHWP Proposes Regulating Health Software as Medical Devices, With Eye to Harmonization

    The Asian Harmonization Working Party (AHWP), a regulatory group focused on the harmonization of regulations across Asia and various other emerging economies , has released for comment a new white paper regarding medical device software regulation in which it proposes the future regulation of software as a medical device (SaMD). The paper notes the need to identify and assess medical software according to its "risk profile" in order to "determine the degree of r...
  • AHWP Unveils Four Guidance Documents Aimed at Regulation of IVDs

    The Asian Harmonization Working Party (AHWP), a medical device-focused regulatory harmonization group, has released an additional four documents for consultation and public comment, just days after releasing two other documents. Background AHWP is an international organization focused on harmonizing medical device regulation and policies across its 23 member countries. While those countries are primarily in Asia-China, India, Saudi Arabia, Singapore, etc-the group also ...
  • AHWP Calls for Comments on Adverse Events, Quality System Guidances

    The Asian Harmonization Working Party (AHWP) has announced the release of two proposed regulatory documents for public comment, one on adverse event reporting for medical devices and the other on the quality management system used by device manufacturers. AHWP is an international organization focused on harmonizing medical device regulation and policies across its 23 member countries. While those countries are primarily in Asia-China, India, Saudi Arabia, Singapore, etc-...
  • Asian Regulatory Harmonization Plan Calls for Investments in Regulatory Capacity

    The Asian Harmonization Working Party (AHWP), a standards harmonization group focused on medical devices, has released a strategic framework and two proposed standards for public comment. The group, established in 1999, includes 23 countries across Asia, Latin America and the Middle East and now considers itself the, "Largest medical device regulatory harmonization body in the world." The group's forward-looking strategic framework, which it bills as the " Strategic Fra...
  • Asian Harmonization Working Party Joins ISO, IMDRF

    The Asian Harmonization Working Party (AHWP) has announced it has been accepted as a member in both the International Medical Devices Regulators Forum (IMDRF) and the International Standards Organization (ISO). AHWP is a non-profit dedicated to the harmonization of medical device regulations, and includes among its members China, India, Saudi Arabia, Korea, South Africa and Pakistan. The organization said IMDRF had extended an invitation for AHWP to join its Forum as ...
  • AHWP Looking to Expand Administrative Staff

    The Asian Harmonization Working Party (AHWP) is looking to expand their staff, according to minutes from the regulatory forum's 4 March Board of Directors meeting held in Hong Kong. AHWP is a medical device-focused regulatory forum that aims to promote greater regulatory harmonization in Asia, including China, India, Saudi Arabia, Pakistan, South Africa and Korea. The group's actions are carried out by a legal entity known as the AHWP Administrative Services Limited (AS...