Expression of Interest for Medical Device Registration Voluntary Feasibility Study

SAHPRA intends to conduct a voluntary feasibility study for medical device registration to validate the proposed process for registration of medical devices.

The medical device registration feasibility study is only for medical devices intended for human use and aims to provide an approach to benefit stakeholders, enabling the registration of medical devices which are currently either legally imported into South Africa or manufactured in South Africa.

Requirements

The Authority invites application for participation in the registration of a medical device voluntary feasibility study, from holders of a medical device establishment licence where the licensed activity in South Africa includes

• importation of a medical device into South Africa (with or without labelling in South Africa), or
• manufacture of a medical device in South Africa, or
• both of the above scenarios.

Only one medical device will be considered for the medical device registration feasibility study from each holder of a medical device establishment licence.

The Authority aims to include a range of IVDs and non-IVDs used to diagnose and monitor HIV and TB into the medical device voluntary feasibility study and will ideally include both medical devices manufactured in  South Africa and imported class C and D medical devices into the medical device voluntary feasibility study

Procedure

Interested applicants to submit the following:

• Expression of Interest for Medical device registration voluntary feasibility study Annexure A on communication document must be submitted to mdreg@sahpra.org.za
• Only documents in pdf must be uploaded.
• Further communication will be limited to selected applicants

Document links:

• Guideline for Classification of Medical Devices and IVDs
• Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs
• [Draft] SAHPGL-MD-11_v2 – New template Conformity assessment guidance
• [Draft] SAHPGL-MD-10_V2 – Registration of non IVD tech dossier
• [Draft] SAHPGL-MD-09_V2 – Registration of an IVD tech dossier
• [Draft] SAHPGL-MD-01_v4 – Medical Devices and IVDs Essential Principles of Safety & Performance
• [Draft] Proposed SAHPRA Guideline Medical Device Registration Process
• [Draft] Declaration of Conformity guidance
• [Draft] Assembly and technical guide for technical dossier content IVD and nonIVD
• [Draft] Market authorisation history declaration template
• [Draft] Manufacturer_Distributor DoC template
• [Draft] GLF-MD-14A – CLASSIFICATION MATRIX Form

Closing date for submission is 28 June 2024 . No late submissions will be accepted.

Enquiries: mdreg@sahpra.org.za