PATIENT PROTECTION
Time running out for medical-device licensing applications
About 100 manufacturers, importers and distributors have applied for licences ahead of the August 23 deadline
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 Jo...
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