Regulatory, SAHPRA

SAHPRA have issued a revised version of the guideline on Classification of Medical Devices as Version 5.

The changes in in this version are:

  • Update in Rule 8, Implantable Medical Devices (Long Term) – Implantable maxillofacial implants and devices such as nails, plates and screws for small joints and long term orthopaedic use are downgraded from Class D to Class C.
  • Typographic corrections on pages 17 and 18.
Rule 8, Version 5

According to Dr Dimakatso Mathibe, Senior Manager for Medical Devices at SAHPRA, License holders don’t have to do an amendment to update their product classes where they already exist in Sections 4, 17 and 18 of the application form. This should be done when amendments are don’t for adding or removing products, or updating any other information appearing on the Medical Device License.

8.05 – Classification Medical Devices IVDs August21_v5Download

Additional information is available on www.sahpra.org.za

Mark Banfield is an independent consultant in Health Technology, providing consulting and advisory services for Business Development, Market research, Quality Assurance and Regulatory Compliance.

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