Time running out for licensing applications

Makers, importers and distributors of medical devices have only a few days left to apply for Medicines Control Council licences.

Medical-device manufacturers, importers and distributors have just more than a week left to apply for licences with the Medicines Control Council (MCC), as it takes a step closer to regulating the industry.

The lack of regulatory oversight of medical devices means patients and healthcare professionals are vulnerable to dangerous or ineffective products, but the extent to which patients are exposed to substandard items is unknown, as there is no formal mechanism for reporting problems. Doctors have been guided by European and US regulators, but this has not always guaranteed patient safety: there have been several recent global safety scandals over devices that had been passed by European or US regulators that turned out to cause harm.

These devices, which include titanium hip replacements and silicon breast implants, were used in South African patients.

About 100 manufacturers, importers and distributors have applied for licences ahead of the August 23 deadline, said MCC registrar Joey Gouws.

Wholesalers have until February to apply for theirs.

The MCC will shortly make way for the South African Health Products Regulatory Agency (Sahpra), which will take over the regulation of the medical device market.

The MCC will cease to exist on the night before the first meeting of the Sahpra board, which has yet to be appointed by Health Minister Aaron Motsoaledi. The Department of Health called recently for nominations to the board and is considering the applications. An announcement is likely before the end of August, said Gouws.

Once the licensing process is completed, Sahpra will begin registering medical devices.

It is expected to run a process along similar lines to that used when medicines were first regulated in 1965: the products on the market will remain for the time being, and devices will be assessed one class at a time, starting with high-risk products. Once a class of devices has been assessed, only those that pass muster will be registered by the agency and allowed to remain on the market.

South African Medical Device Association executive officer Tanya Vogt said the reg- ulatory changes were “absolutely necessary in terms of ensuring patients have access to only safe, effective devices of the highest cost”, but the effect of the changes on the industry, “especially given the costs”, should not be underestimated.

The licence fees were R21,800 for manufacturers and R13,000 for wholesalers and distributors, she said.

“There are over 350,000 different medical devices on the market, with at least 1,000 entering the market monthly. The average life cycle of a device before an upgrade or a new model is developed is 18 to 24 months. The medical device industry has business models and quality management systems different to that of medicines and it is hoped that the regulator will take this into account,” Vogt said.

Gouws said she did not regard licence costs as a major deterrent for the industry.