November 27, 2024, Rwamagana, Iburasirazuba, Rwanda and Tianchang, Anhui, China – Recently, TKMD RWANDA LTD (TKMD) received prequalification (PQ) from the World Health Organization (WHO) for its auto-disable syringes (AD syringes), which will be supplied to the United Nations Children’s Fund (UNICEF) for immunization programs across African nations. This marks the first WHO pre-qualified syringe product in Rwanda, further enhancing Africa’s local production and supply capabilities for vaccine syringes.

The AD syringes, recommended by WHO for vaccination and required in Gavi programs, will automatically disable at the start of administration, preventing the risk of reuse and cross-contamination. Due to their advanced safety features, these syringes have been used to successfully prevent the transmission of blood-borne pathogens including HIV, Hep B and Hep C. This is reinforced by a joint statement, the WHO, UNICEF, and the United Nations Population Fund issued for the use of AD syringes, to ensure safety in immunization programs globally.

The AD vaccine syringes produced by the Rwanda TKMD factory are in urgent demand across Africa. Currently, the continent’s various routine immunization programs require a significant number of the AD syringes, with Sub-Saharan Africa alone requiring up to 500 million units annually. Historically, Africa has also been dependent on syringe supply primarily from Asia which takes 3-4 months by sea to reach many countries. TKMD has the ability to greatly shorten transportation times which will lead to faster response for outbreak vaccination especially. And In the long run, there will be a sustained increase in the demand for AD syringes with an increasing number of newborns that need immunization in Africa.

To meet this demand and ensure a resilient supply chain, the Bill & Melinda Gates Foundation has provided a grant to TKMD to build a factory in Rwanda. The annual production capacity is 300 million units with the intention of supplying these products to immunization programs across Africa at an affordable price. Presently, the factory is producing the 0.5mL AD syringe to address the immediate need for immunization, but has the capability to adapt product lines to address other types of syringes that may be required in the future.

Jinkun Bai, General Manager of TKMD RWANDA, said: “TKMD has been a key syringe supplier to UNICEF. Local production in Africa faces significant challenges due to the lack of supply chain for raw materials, which means that hundreds of production materials need to be imported to sustain the local manufacturing of a single product. The funding and technical support from the Gates Foundation have mitigated the risks associated with local production in Africa, strengthening our confidence to overcome these challenges and supply UNICEF with syringes produced locally in Rwanda. TKMD’s AD syringes will be primarily used for immunization programs in LMICs across Africa and will also support pandemic preparedness on the continent.”

Surabhi Rajaram, Program Officer, Immunization at the Gates Foundation, stated: “Increasing equitable access to immunization has always been one of the priorities of the Gates Foundation. A reliable supply of high-quality, affordable immunization syringes is essential to achieving this goal and upholding a safe injection experience. To this end, the Gates Foundation made the decision to support TKMD in Rwanda and another medical device manufacturer in Kenya to strengthen the local production capacity of immunization syringes in Africa. We are thrilled to see that both grantees have received approval from WHO, and we look forward to the impact this will have to make sure people across the continent have timely access to life-saving vaccines. ”

TKMD Rwanda chief quality inspector and equipment maintainers with the injection molding production line

The production scene of machine automatically assembling AD vaccine syringes needle tips at TKMD Rwanda

The Rwanda TKMD factory is located in Mwulire, Rwamagana, Iburasirazuba, Rwanda. The factory will hire only locally to create jobs in the community and a sustainable operation in the longer term. Currently, the factory employs 60 key staff members who are undergoing training to build technical and commercial expertise. Per targets in the investment and a joint commitment to gender equality, TKMD is on track to hire women to comprise 70% of workforce.

About TKMD

Anhui Tiankang Medical Technology Co.,Ltd., established in 1999, is a subsidiary of Anhui Tiankang Group. Committed to improving public health, the company specializes in developing and manufacturing medical consumables such as safety syringes with retractable needles, auto-disable syringes, I.V sets, T.V sets, extracorporeal blood circuits for hemodialyzers, oral syringes, I.V catheter and intravenous infusion sets with burettes.

The company owns a plant area of over 600 acres in Anhui Province and employs over 1,000 people, including over 430 senior and intermediate technical engineers (approximately 39% of the total workforce). To date, the company has applied for 35 patents, including 4 national invention patents, 7 foreign invention patents, 20 national utility model patents, and 1 national design patent, which have been validated by the corporate technology center of Anhui Province. The company is also a certified high-tech enterprise, and a member unit in compliance with the national syringe and infusion standards.

TKMD has obtained the European CE certificate (2002), ISO 13485 certificate (2002), and WHO-PQS certificate (2010), all of which have enabled the company to expand into international markets including Europe, Africa, and Latin America.