Global Harmonization Working Party (GHWP)
The Global Harmonization Working Party (GHWP) is an international platform that brings together experts from medical device regulatory authorities and industry stakeholders. Its core mission is to promote the harmonization and convergence of medical device regulations worldwide. By developing strategic approaches and aligning regulatory frameworks across countries, GHWP facilitates regulatory consistency, enhances transparency, and fosters mutual trust between regulators and the medical device
Working closely with leading global organizations such as the International Medical Device Regulators Forum (IMDRF), GHWP advocates for a science based, flexible, and risk based regulatory model that adapts to evolving technologies and scientific innovations while ensuring patient safety and access to high-quality medical devices. Beyond harmonization, GHWP is also dedicated to capacity building by offering structured training, technical guidance, and information-sharing platforms to equip regulatory professionals with up-to-date skills and knowledge.
Since 2014, the Tanzania Medicines and Medical Devices Authority (TMDA) has been an active member of GHWP, underlining its commitment to international collaboration and regulatory excellence. TMDA represents Tanzania among the 34 GHWP member countries, serving as both the National Regulatory Authority representative and a member of the Technical Committee (TC), as listed on the GHWP official website.
Currently, TMDA actively participates in eight GHWP Technical Working Groups (TWGs), which address critical areas related to the regulation of medical devices and in-vitro diagnostics (IVDs). These working groups are instrumental in shaping international best practices and harmonized guidelines.
| Working group | name of the working group | Name of TMDA representative |
| 1 | Pre - Market Submission and CSDT | 1. Ms. Gudula Sabina Mpanda |
| 2 | Pre - Market: IVDD | 2. Ms. Engerasia Thomas Mtui |
| 3. Ms. Rehema Forgen Mariki | ||
| 3 | Pre - Market: Software as a Medical Device | 4. Mr. David Aden Mwakyoma |
| 4 | Post Market | 1. Mr. David Matle |
| 2. Mr. Kazimil Kishosha | ||
| 3. Ms. Rose Zakaria Maingu | ||
| 5 | Clinical Evidence for Performance and Safety | 1. Mr. Christian Natalis Kapinga |
| 7 | Quality Management System | 1. Mr. Haninu Salumu Nakuchema |
| 2. Ms. Gudula Sabina Mpanda | ||
| 8 | Standards | 1. Mr. Edinanth Gareba |
| 9 | UDI & Nomenclature | 2. Dr. Shani Maboko |
Through its active participation in GHWP’s annual meetings and technical initiatives, TMDA continues to strengthen its regulatory capacity, enhance technical expertise, and align its practices with internationally recognized standards. This collaboration enables TMDA to effectively regulate emerging medical technologies and ensures the availability of safe, effective, and high-quality medical devices in Tanzania, thereby supporting public health and fostering innovation in the healthcare sector.