---

The Botswana Medicines Regulatory Authority (BoMRA) has made a significant step towards strengthening its medical device regulatory framework by joining the International Medical Devices Regulatory Forum (IMDRF) and the Global Harmonization Working Party (GHWP).

This deliberate move by BoMRA aims to improve collaboration, innovation, and global alignment in the regulation of medical devices.

About IMDRF and GHWP

There are many challenges associated with fragmented regulatory systems; central of which is limited access to critical health products and technologies.

Duplication of regulatory efforts and bureaucracy are some of the barriers that many pharma companies have to navigate in the pursuit of entry into key markets.

Consequently, most elect to abandon the idea altogether, leaving many patients, especially in Africa, at a unique disadvantage.

That’s where the IMDRF and GHWP come in.

The International Medical Devices Regulatory Forum is a platform that accelerates international medical device regulatory convergence thereby encouraging an efficient and effective regulatory model for medical devices.

Some members of IMDRF include the European Union, USA, and the United Kingdom, with key African affiliate members consisting of Egypt, Kenya, South Africa, Nigeria, and now Botswana.

The Global Harmonization Working Party, on the other hand, is an organization whose vision centers around promoting international harmonization of medical device regulatory frameworks among regulatory authorities, convergence of regulatory requirements, and open and trust-based efforts between regulatory authorities and the industry across the globe.

Botswana will be joining the likes of Zimbabwe, Kenya, Ghana, and South Africa as the African nations active in this initiative.

Both the IMDRF and GHWP advance harmonization reliance mechanisms in regulation of medical devices, an aspect that BOMRA has stated aligns with their mission.

---

READ ALSO: EMA accepts for review GSK’s new fully liquid shingles vaccine

---

Significance of these bodies

As an IMDRF and GHWP member, BoMRA will:

• Take part in GHWP and IMDRF events, including open working groups. (WC) and other programs aimed at increasing capacity.

 

• Actively participate in the "open" meetings of the GHWP and IMDRF to provide regulatory updates on medical devices. Explore regulatory tactics and share technical knowledge with the industry and other regulators.

• Make use of and accept the IMDRF and GHWP materials and guidelines as a starting point for standardizing the regulatory framework for medical devices on the continent and internationally.

• Continue working toward the objective of global recognition, confidence, and trust in medical products from Botswana, including in vitro diagnostics (IVD) regulations.

Conclusion

The inclusion of BoMRA and by extension Botswana, is a great move for the country as well as the African continent which is consistently making steps towards achieving a harmonized regulatory space for not only medical devices but also medicines.

Many are optimistic the future of Africa’s pharmaceutical sector is bright, and it's easy to understand why.

---

Did you find this insightful? Subscribe for more.

---