FDA to remove bogus medical devices from the system

The Food and Drugs Authority (FDA),  intends  to exclude sub-standard medical devices from the system by rigorously following the regulatory procedures.

Mrs Akua Amartey, Acting Deputy Chief Executive, Medical Devices, Cosmetics and Household Chemical Substances Division, of the FDA, stated this on Wednesday, during a day’s training programme in Ho, for people who import, distribute, sell and use these devices.

She observed that medical devices were vital tools in healthcare, so that only the good one must be in service.

A fake diagnostic equipment would provide wrong diagnoses, and therefore wrong treatment, which could be catastrophic for the client and eventually the nation, Mrs Amartey stated.

She said guidelines for handling donated items classified as medical devices were being reviewed.

Mr Joseph Bennie, Head of Department, Medical Devices (FDA),  said under the Public Health Act, devices not registered by the FDA were illegal.

He said the registration process could be fluid, ending within six months after the presentation of application.

Mr Bennin explained that  an applicant’s quick responses to queries could reduce registration processing time considerably.

He said the FDA had the right to reject a suggested registration name,  if it could create confusion in the minds of people, and that registration could be cancelled if information on the product turned out to be false.

Mr Bennin pointed out that  no importer could bring into Ghana any medical device without the authorization of the FDA.

He said it was important that clients or users of devices alerted the FDA about bogus products circulating, since they also had a stake in protecting public good.

Source: GNA