Spotlight on medical device regulations

Wednesday, September 7, 2011

Pretoria - A health technology seminar, which seeks to ensure the high quality and safe use of medical devices at public and private health facilities, is currently underway in Boksburg.

Led by Deputy Minister of Health, Dr Gwen Ramokgopa, the two-day seminar, which started today, is in line with the mandate of the Ministry of Health of improving the quality of health care and in pursuit of excellence towards the National Health Insurance (NHI).

It comes after the Department of Health recently gazetted Draft Medical Device Regulations for public comment.

These regulations are geared towards improving health technology and ultimately bring reforms that are required to implement an effective NHI that is responsive to the needs of the South African population.

About 400 international and local health technology experts, including researchers, academics and manufactures and distributors of medical devices attending the seminar are expected to hold discussions on medical device regulations.

During the seminar, speakers from international organisations such as World Health Organization, Global Harmonization Task Force, the Asian Harmonization Working Party and some from established and emerging regulatory authorities like the United Kingdom, Australia and Saudi Arabia will share their country experience.

Commenting on the regulations, Ramokgopa said: "For the first time, South Africa will have comprehensive regulations that are meant to improve safety, quality and performance of all medical devices used at health facilities."

She added that the sale of unsafe and unregistered medical devices will be prohibited. - BuaNews

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