1. ? ? Global Harmonization Working Party (GHWP; or the “Working Party”)?
1.1 ? Vision
To Achieve International Harmonization of Medical Device Regulations through Collaborative Efforts of Regulators and the Industry.
1.2 ? Mission
To Strategically Accelerate Medical Device Regulatory Convergence through Promotion of an Efficient and Effective Regulatory Model for Medical Devices.
1.3 ? Goals
- To develop and recommend approaches for the global convergence and harmonization of medical device regulations.
- 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.?
1.4 ? Membership?
A. ? GHWP 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, a Special Administrative Region of one country). Membership is open to all stakeholders 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 GHWP Secretariat.?
B. ? Upon joining, each country or region should nominate two Primary GHWP Representatives and two Secondary GHWP 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 region such that they could represent the views of both the Regulatory Authority and Industry of their respected countries or regions.
C. ? The Primary and Secondary GHWP 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 GHWP Secretariat. Unless the Secretariat is otherwise informed, the nominated GHWP Primary and Secondary Representatives from the Industry shall be endorsed by the GHWP Primary Representative from the Regulatory Authority of the same country or region, before subscribing to GHWP Secretariat.
1.5 ? Leadership?
One GHWP Chair and two GHWP Vice-chairs shall be elected from Primary GHWP Representatives at the GHWP Annual Meeting through voting by all presented Primary GHWP Representatives for a term of office until the next election. The GHWP Chair and one GHWP Vice-chair shall come from Regulatory Authorities while one GHWP Vice-chair shall come from the Industry. The GHWP Chair and Vice-chairs will normally rotate among members.
1.6 ? Official Observers?
The GHWP 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 GHWP 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 GHWP Meetings. Though members should adopt as far as possible the decisions and resolutions so passed, such decisions and resolutions are not binding on members such 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 GHWP Meetings are open to interested parties to join as observers on a space availability basis.?
1.10 ? Language?
English will be used as the only language in documents and communications of the GHWP. Members may arrange for translation and/or employ interpreters for their own use if needed.
1.11 ? GHWP Meetings?
The Working Party shall meet at regular intervals (normally once a year). The GHWP Chair may organize ad hoc meetings when needed. Meeting locations shall preferably be rotated among members.
2. ? ? Global Harmonization Working Party Technical Committee (GHWPTC; or the “Technical Committee”)?
2.1 ? GHWPTC 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 GHWP Chair for decisions;
? ? ? ? ? ? Submit resolutions to the GHWP 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 resolutions;
? ? ? ? ? ? Develop and submit technical documents and white papers for endorsement;
? ? ? ? ? ? Plan and organize meetings, training, seminars, workshops and experience sharing
? ? ? ? ? ? sessions;
? ? ? ? ? ? Work with related organizations and participate in their activities; and
? ? ? ? ? ? Report on the progress of its activities to the GHWP Meetings.?
2.2 ? GHWPTC Membership?
A. ? Each country or region should nominate two Primary GHWPTC Representatives and two Secondary GHWPTC 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 GHWP Representative from the Regulatory Authority shall nominate both the Primary and Secondary GHWPTC Representatives for the Regulatory Authority of his/her country or region. The Primary and Secondary GHWPTC 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 GHWPTC Primary and Secondary Representatives from the Industry shall be endorsed by the GHWP Primary Representative from the Regulatory Authority of the same country or region, before subscribing to GHWP Secretariat.
2.3 ? GHWPTC Leadership?
One GHWPTC Chair and two GHWPTC Co-chairs shall be elected by the GHWP Primary Representatives among the GHWPTC Representatives at the GHWPTC Meeting that is held in conjunction with the GHWP Annual Meeting. The GHWPTC Chair and one GHWPTC Co-chair shall come from the Regulatory Authorities while one GHWPTC Co-chair shall come from the Industry. In the absence of the GHWPTC Chair at a given GHWPTC Meeting, the GHWPTC Co-chair from the Regulatory Authority shall assume the duties of the GHWPTC Chair. In the absence of both the GHWPTC Chair and Co-chair from the Regulatory Authority, the GHWPTC Co-chair from the Industry shall assume the duties of the GHWPTC Chair.
2.4 ? Working Groups (WGs) and Special Task Groups (STGs)?
A. ? With the consent of the GHWP Chair, the GHWPTC 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 GHWPTC Chair may appoint Acting Chairs and Co-chairs to take charge of the newly formed Groups until the next GHWP Meeting in which the Chairs and Co-chairs of the newly formed Groups are elected.?
C. Chairs of Working Groups and Special Task Groups are preferably from different countries / regions, except for the case where there is only one candidate for a vacant of WG Chair or STG Chair, such candidate would also be considered.
2.5 ? GHWPTC Meetings?
The GHWPTC Chair may organize GHWPTC Meetings as and when needed. At least one of the GHWPTC Meetings shall be held in conjunction with the GHWP Annual Meeting in which the GHWPTC Chair shall report on the developments and achievements of the Technical Committee.?
3. ? ? Terms of Representation, Resolutions & Decisions?
3.1 ? Representation?
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. ? GHWP and GHWPTC Representatives may initiate resolutions and recommendations for discussions and voting at the GHWP Meetings and GHWPTC Meetings respectively. Requests shall be made to the GHWP Secretariat and copied to the GHWP Chair and GHWPTC Chair at least one week before the relevant Meeting. Any proposed amendments to the resolutions shall be made to the GHWP Secretariat and copied to the GHWP Chair and GHWPTC Chair at least one day before the relevant meeting.?
B. ? A simple majority is needed for passing any resolutions and recommendations at the GHWP Meetings and GHWPTC Meetings respectively.?
C. ? GHWPTC Representatives may initiate resolutions of GHWPTC technical documents and white papers for discussions and endorsements through electronic means and/or at GHWPTC Meetings by GHWPTC Representatives.?
D. ? A simple majority is needed for any endorsements of GHWPTC technical documents and white papers through electronic means by GHWPTC Representatives.?
4. ? ? Voting, Nomination, Election, Terms of Service, Change of Office Bearers /Representatives and Representation in the Absence of Representatives?
4.1 ? Voting?
Each Primary GHWP Representative shall have one vote at the GHWP Meeting. Each Primary GHWPTC Representative shall have one vote at GHWPTC Meeting.?
4.2 ? Nomination?
Primary GHWP Representatives may propose nominations for election as office bearers in the GHWP, GHWPTC, WGs and STGs.?
4.3 ? Election?
Nominees with the highest number of votes shall be elected as office bearers.?
4.4 ? Terms of Office
The terms of office of all GHWP and GHWPTC office bearers will be around three years commencing from the date of appointment until the next election. All office bearers in the GHWP, GHWPTC, WGs and STGs, regardless of when they are elected into the office during the term of a given GHWP Chair, shall retire altogether at the same time with that GHWP Chair. The current GHWP Chair is responsible for organizing the next election of new office bearers in an GHWP 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 GHWP Representative of the corresponding country or region shall nominate replacements to fill any vacancies arise. If the Primary GHWP Representative of the country or region fails to make nominations for such replacements for any reason, the GHWP Chair may appoint acting replacements until new office bearers are elected to fill the relevant vacancies in the next GHWP Meeting.
4.6 ? Representation in the absence of the Representatives?
Secondary GHWP and GHWPTC Representatives could take up all the roles and responsibilities as well as voting rights of the corresponding Primary GHWP and GHWPTC Representatives in their absence. In case that both the Primary and Secondary GHWPTC Representatives are absent, the corresponding Primary GHWP Representative could take up all the roles and responsibilities as well as voting rights at the GHWPTC Meetings. Similarly, Primary GHWPTC Representatives could take up all the roles and responsibilities as well as voting rights at GHWP Meetings if the corresponding Primary and Secondary GHWP 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.?
1. ? ? Global Harmonization Working Party (GHWP; or the “Working Party”)?