Dr Mimi Delese Darko — Chief Executive Officer, FDA
Dr Mimi Delese Darko — Chief Executive Officer, FDA

FDA cautions against importing unregistered baby diapers

The Food and Drugs Authority (FDA) has cautioned manufacturers, importers and distributors of baby diapers against importing unregistered and unsanitary baby diapers, also known as bale diapers, into the country. 


That, the authority explained, was against the FDA Guideline for Registration of Medical Devices (Appendix II) and the Ghana Standard Authority’s specifications for single-use disposable baby diapers (GS 1166:2017).

A press statement signed and issued on Monday, April 8, by the Chief Executive Officer of FDA, Dr Mimi Delese Darko, said the importation of unregistered, poor quality and unhygienically packaged products would result in their seizure, and therefore, the safe disposal of the diapers would be at a cost to the importer. 

“The above notwithstanding, the Authority has noted with great concern the continuing practice where disposable baby diapers are still imported into the country, either unhygienically packaged in bales or hidden in bales of used clothing,” it added.

Consequently, the authority urged the public to buy only registered baby diapers to help protect babies from the risk of infections. It said some of such baby diapers were repackaged and offered for sale without adequate label information or no labelling information at all. 


The statement reminded the public that materials used for baby diapers were tested by the authority during the product registration process. That, it explained, was to ensure that any dyes, skin irritants or toxins were absent so as not to cause harm to babies. 

It further explained that the handling of bale diapers, frequently re-packed and relabelled under insanitary conditions, could cause germs to enter the genital region of a child, especially the girl-child. 

It said that could further pose a great danger to the health and well-being of the child. 


The authority entreated importers to have their products registered with an approved label before importing them to the country for sale. It explained that the registered baby diapers should be evaluated by the FDA and conform with GS 1166:2017. 

“All registered diapers imported into the country must be well-packaged and properly sealed to protect the product from moisture, soiling, contamination and damage during transportation, storage and distribution throughout the product’s shelf-life,” it stressed.

The Authority said it would allow the importation of raw materials for the manufacture of baby diapers. However, the importer should possess a licensed facility for the manufacture of baby diapers.

“All facilities, both local and foreign, for the manufacture of baby diapers are subjected to good manufacturing practice inspection. The relevant fees apply,” it added. 

The FDA said it was committed to working with the Ghana Revenue Authority (GRA) Customs Division to ensure that disposable baby diapers on the market were safe and meet the required standards.

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