1. Asian Harmonization Working Party (AHWP; or the “Working Party”)
To Achieve International Harmonization of Medical Device Regulations through Collaborative Efforts of Regulators and the Industry in Asia and other continents.
To Strategically Accelerate Medical Device Regulatory Convergence through Promotion of an Efficient and Effective Regulatory Model for Medical Devices.
- To develop and recommend approaches for the convergence and harmonization of medical device regulations in Asia and other continents.
- To facilitate the exchange of knowledge and expertise amongst regulators and the industry for the establishment of harmonized requirements.
- To promote capacity building in members and to foster strategic membership expansion.
- To work in collaboration with related international organizations such as International Medical Device Regulators Forum(IMDRF), WHO, ISO, IEC.
A. AHWP is a non-profit organization which consists of regulatory authorities and industry. Its members come from the Medical Device Regulatory Authorities (“Regulatory Authorities”) and the medical device industry including government agencies which are not Medical Device Regulatory Authorities (“Industry”) of a country or region (Region includes, for example, aSpecial Administrative Region of one country). Membership is open to those representatives from the Asian and other continents that support the above stated goals. Any regulatory authority and industry of a country and/or regions interested in joining the Working Party may be admitted subject to a majority support from existing members. The full list of members will be kept by the AHWP Secretariat.
B. Upon joining, each country or regionshould nominate two Primary AHWP Representatives and two Secondary AHWP Representatives, with one each from the Regulatory Authority and one each from the Industry. Representatives from the Regulatory Authority shall be responsible persons in the development and implementation of medical device regulatory frameworks while those from the Industry shall be senior managers from the industry of the country or regionsuch that they could represent the views of both the Regulatory Authority and Industry of their respected countries or regions.
C. The Primary and Secondary AHWP Representatives from the Regulatory Authority of a country or region shall be nominated by the medical device regulatory authority of the corresponding government. All organizations from the Industry shall nominate the Primary and Secondary Representatives to subscribe to the AHWP Secretariat. Unless the Secretariat is otherwise informed, the nominated AHWP Primary and Secondary Representatives from the Industry shall be endorsed by the AHWP Primary Representative from the Regulatory Authority of the same country or region, before subscribing to AHWP Secretariat.
One AHWP Chair and two AHWP Vice-chairs shall be elected from Primary AHWP Representatives at the AHWP Annual Meeting through voting by all presented Primary AHWP Representatives for a term of office until the next election. The AHWP Chair and one AHWP Vice-chair shall come from Regulatory Authorities while one AHWP Vice-chair shall come from the Industry. The AHWP Chair and Vice-chairs will normally rotate among members.
1.6 Official Observers
The AHWP leadership may designate Official Observers on the basis of expected contribution and value. Official Observers must be approved by the unanimous consent of the voting members present in AHWP annual meetings. Official Observers do not participate in the decision making process.
1.7 Decisions and Resolutions
The Working Party shall operate on a consensus basis. Decisions and resolutions on key issues and controversial matters should be made only after thorough discussions before voting at AHWP Meetings. Though members should adopt as far as possible the decisions and resolutions so passed, such decisions and resolutions are not binding on memberssuch that they may elect alternatives and decide their own implementation plans taking account of their local situations.
1.8 Relationship with Other Parties
The Working Party shall work closely with other international organizations to identify areas of compatibility and cooperation towards harmonization of medical device regulations.
1.9 Observers to Meetings
It is our belief that the message of harmonization will be better spread and promoted with observers from different corners of the world participating in the meetings. All AHWP Meetings are open to interested parties to join as observers on a space availability basis.
English will be used as the only language in documents and communications of the AHWP. Members may arrange for translation and/or employ interpreters for their own use if needed.
1.11 AHWP Meetings
The Working Party shall meet at regular intervals (normally once a year). The AHWP Chair may organize ad hoc meetings when needed. Meeting locations shall preferably be rotated among members.
2. Asian Harmonization Working Party Technical Committee (AHWPTC; or the “Technical Committee”)
2.1 AHWPTC is the executive arm of the Working Party. It performs the following roles and responsibilities to support the Working Party:
• Execute the Working Party’s decisions and resolutions;
• Make recommendations to the AHWP Chair for decisions;
• Submit resolutions to the AHWP Meetings for decisions of key issues related to
the policy, direction, organization, structure and operation of the Working Party;
• Provide expert opinions and advices;
• Develop and submit policy papers for reolutions;
• Develop and submit technical documents and white papers for endorsement;
• Plan and organize meetings, training, seminars, workshops and experience sharing
• Work with related organizations and participate in their activities; and
• Report on the progress of its activities to the AHWP Meetings.
2.2 AHWPTC Membership
A. Each country or region should nominate two Primary AHWPTC Representatives and two Secondary AHWPTC Representatives, with one each from the member Regulatory Authority and one each from the member Industry. The Representatives shall be knowledgeable experts in medical device regulatory services and be able to represent the views of the Regulatory Authority and Industry of their country or region.
B. The Primary AHWP Representative from the Regulatory Authority shall nominate both the Primary and Secondary AHWPTC Representatives for the Regulatory Authority of his/her country or region. The Primary and Secondary AHWPTC Representatives from the Industry should be nominated by the industry representatives of their own country or region. Unless the Secretariat is otherwise informed, the nominated AHWPTC Primary and Secondary Representatives from the Industry shall be endorsed by the AHWP Primary Representative from the Regulatory Authority of the same country or region, before subscribing to AHWP Secretariat.
2.3 AHWPTC Leadership
One AHWPTC Chair and two AHWPTC Co-chairs shall be elected by the AHWP Primary Representatives among the AHWPTC Representatives at the AHWPTC Meeting that is held in conjunction with the AHWP Annual Meeting. The AHWPTC Chair and one AHWPTC Co-chair shall come from the Regulatory Authorities while one AHWPTC Co-chair shall come from the Industry. In the absence of the AHWPTC Chair at a given AHWPTC Meeting, the AHWPTC Co-chair from the Regulatory Authority shall assume the duties of the AHWPTC Chair. In the absence of both the AHWPTC Chair and Co-chair from the Regulatory Authority, the AHWPTC Co-chair from the Industry shall assume the duties of the AHWPTC Chair.
2.4 Working Groups (WGs) and Special Task Groups (STGs)
A. With the consent of the AHWP Chair, the AHWPTC Chair may create Working Groups and Special Task Groups for carrying out specific tasks and duties of the Technical Committee. Each Group shall have one Chair from the Regulatory Authority and one Co-chair from the Industry.
B. The AHWPTC Chair may appoint Acting Chairs and Co-chairs to take charge of the newly formed Groups until the next AHWP Meeting in which the Chairs and Co-chairs of the newly formed Groups are elected.
2.5 AHWPTC Meetings
The AHWPTC Chair may organize AHWPTC Meetings as and when needed. At least one of the AHWPTC Meetings shall be held in conjunction with the AHWP Annual Meeting in which the AHWPTC Chair shall report on the developments and achievements of the Technical Committee.
3. Terms of Representation, Resolutions & Decisions
The Regulatory Authorities are agencies responsible for the regulation of medical devices in the countries or regions. The Industry includes all business and services related to the manufacturing, supply, distribution, usage, procurement, maintenance, testing, conformity assessment and supporting services related to medical devices. Government, semi-government and non-government bodies not directly responsible for the regulation of medical devices are regarded as part of the Industry for the purpose of the Working Party.
3.2 Resolutions, Endorsements & Decisions
A. AHWP and AHWPTC Representatives may initiate resolutions and recommendations for discussions and voting at the AHWP Meetings and AHWPTC Meetings respectively. Requests shall be made to the AHWP Secretariat and copied to the AHWP Chair and AHWPTC Chair at least one week before the relevant Meeting. Any proposed amendments to the resolutions shall be made to the AHWP Secretariat and copied to the AHWP Chair and AHWPTC Chair at least one day before the relevant meeting.
B. A simple majority is needed for passing any resolutions and recommendations at the AHWP Meetings and AHWPTC Meetings respectively.
C. AHWPTC Representatives may initiate resolutions of AHWPTC technical documents and white papers for discussions and endorsements through electronic means and/or at AHWPTC Meetings by AHWPTC Representatives.
D. A simple majority is needed for any endorsements of AHWPTC technical documents and white papers through electronic means by AHWPTC Representatives.
4. Voting, Nomination, Election, Terms of Service, Change of Office Bearers /Representatives and Representation in the Absence of Representatives
Each Primary AHWP Representative shall have one vote at the AHWP Meeting. Each Primary AHWPTC Representative shall have one vote at AHWPTC Meeting.
Primary AHWP Representatives may propose nominations for election as office bearers in the AHWP, AHWPTC, WGs and STGs.
Nominees with the highest number of votes shall be elected as office bearers.
4.4 Terms of Office
The terms of office of all AHWP and AHWPTC office bearers will be around three years commencing from the date of appointment until the next election. All office bearers in the AHWP, AHWPTC, WGs and STGs, regardless of when they are elected into the office during the term of a given AHWP Chair, shall retire altogether at the same time with that AHWP Chair. The current AHWP Chair is responsible for organizing the next election of new office bearers in an AHWP Meeting in about three years’time after his/her election.
4.5 Change of Office Bearers and Representatives
When there are changes to office bearers, the Primary AHWP Representative of the corresponding country or region shall nominate replacements to fill any vacancies arise. If the Primary AHWP Representative of the country or region fails to make nominations for such replacements for any reason, the AHWP Chair may appoint acting replacements until new office bearers are elected to fill the relevant vacancies in the next AHWP Meeting.
4.6 Representation in the absence of the Representatives
Secondary AHWP and AHWPTC Representatives could take up all the roles and responsibilities as well as voting rights of the corresponding Primary AHWP and AHWPTC Representatives in their absence. In case that both the Primary and Secondary AHWPTC Representatives are absent, the corresponding Primary AHWP Representative could take up all the roles and responsibilities as well as voting rights at the AHWPTC Meetings. Similarly, Primary AHWPTC Representatives could take up all the roles and responsibilities as well as voting rights at AHWP Meetings if the corresponding Primary and Secondary AHWP Representatives are both absent. However, representatives from the Regulatory Authority shall not represent representatives from the Industry. Similarly, representatives from the Industry shall not represent representatives from the Regulatory Authority.
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