Regulation of Medical Gases
Medical gases are gases utilized in hospitals and healthcare facilities as a key component in life supporting systems. These include gases used for anesthesia and life support.
They are packed as compressed gas under pressure in cylinders or liquefied gas at high or low pressure and administered to patients through designated valves or evaporation and delivery by using hospital delivery systems.
Medical gases include oxygen, nitrous oxide, nitrogen, carbon dioxide, medical air and helium.
Dealers of medical gases
TMDA has grouped the dealers of medical gases into four categories based on their functions in relation to their dealing with medical gases.
- Category 1: Manufacturers of Medical gases (domestic and foreign)
- Category 2: Hospitals that manufacture their own gases
- Category 3: Hospitals that receive bulk gase have installed piping systems for distribution within their systems
- Category 4: Wholesaler/Distributor
Requirements for dealers of medical gases
All dealers in medical devices need to register their premises at TMDA.
An importer of medical devices has to be registered as a dealer of medical gases.
Applications for business permits and premise registration can be made through the online Trader Portal.
Processing of premise applications is done by TMDA Zone offices.
Approved dealers of Medical Devices
| Manufacturersof Medical gases (domestic and foreign) | ||
| Manufacturer Name | Manufacturer Physical Address | Manufacturer Region |
| Kamal Gases Ltd | Plot No. 188/2 Mwakalinga Road, Chang'ombe | Dar es Salaam |
| Tol Gases Limited | 911, Dar Es Salaamplot 4b, Nyerere Road. | Dar es Salaam |
| Salima Oxygen Limited | Mbagala Industrial Area | Dar es Salaam |
| O2 Limited | Plot No 20 A Kisesa Industrial Area | Mwanza |
| Mwanza Gaz Limited | Plot 3 & 4 / Block “L”Kigongo Ferry Road – Misungwi - MwanzaKigongo Ferry Road – Misungwi - Mwanza | Mwanza |
| Industrial Gases And Chemicals Ltd | Nyakato, Industrial Area | Mwanza |
| ALMC Oxygen Plant | Arusha Lutheran Medical Centre, P.O BOX 17047 | Arusha |
| Afro Multi Gases Limited | Esso Unga, Ltd, P.O BOX 3082 | Arusha |
| Haydom Lutheran Hospital Oxygen Plant | Haydom, P.O BOX 9000 Haydom | Manyara |
| GSF Oxygen Plant | Off Sokoine Road, Longuo B, Moshi - Kilimanjaro, P. O. Box 3010 | Kilimanjaro |
| Atlas Company Limited | P.O.Box 4068,Plot No.11 | |
| Hospitals that manufacture their own gases | ||
| Manufacturer Name | Manufacturer Physical Address | Manufacturer Region |
| Muhimbili National Hospita( Upanga ) | Upanga | Dar es Salaam |
| Muhimbili National Hospita( Mloganzila ) | Kibamba | Dar es Salaam |
| Tumbi hospital | Kibaha | Coast |
| Rabininsia | Namanga Tegeta | Dar es Salaam |
| Bugando Medical Centre | Plot No 229, Block Z, Bugando Hill | Mwanza |
| Manyara RRH Oxygen Plant | Babati, P.O BOX 577 | Manyara |
| St,Benedict Ndanda Referral Hospital | Box 3 Ndanda-0678748587 | Mtwara |
| KCMC | ||
| Dodoma Regional Refferral Hospital | P.O.Box 904,Madukani | Dodoma |
| Dodoma Christian Medical Trust | P.O.Box 658 | Dodoma |
| Hospitals that have installed piping systems for distribution of bulk gas within their systems | ||
| Manufacturer Name | Manufacturer Physical Address | Manufacturer Region |
| Muhimbili Orthopaedic Institute | Upanga | Dar es Salaam |
| Jakaya Kikwete Cardiac Institute | Upanga | Dar es Salaam |
| Agakhan Hospital | Seaview | Dar es Salaam |
Market Authorization of Medical Gases
TMDA is mandated to authorize the marketing of medical gases in Tanzania Mainland. Market authorization of medical gases is through notification
Procedures for notification of medical devices:
- Register your premise at TMDA
- Compile the required documents as per section 3.4 of the Guidelines for Notification of Medical Devices Exempted from Registration
- Lodge the application through trader's Portal.