Medical Device Registration Feasibility Study Phase 1 and Phase 2

1. Key takeaways

South Africa’s voluntary medical device registration feasibility study is the pilot programme through which SAHPRA validates the design of its registration process before formal call-up: Phase 1 launched its call for expressions of interest on 17 May 2024, focusing on HIV and TB related IVDs and non-IVDs, with a target of 32 products and approximately 22 actually received; the Medical Device Registration Feasibility Study Report was published on 31 March 2026. Phase 2 (2026) turned to oncology (breast, prostate and lung cancer), dominated by Class C and Class D devices, with an addendum issued on 9 September 2026 extending the call for expressions of interest, closing on 18 September 2026 at 16:30, and the study is expected to run until the end of 2027. Participation carries no application fee, but it also produces no registration number.

2. Legal basis

3. Expert insights

Insight one: the feasibility study is a process trial, not a product registration. SAHPRA’s stated purpose is to validate the proposed registration process, allowing the Authority to see which elements of it work before it becomes mandatory. Participants receive an acknowledgement letter, portal training and a working relationship with the regulator, but they do not obtain a registration number. Any understanding that equates participation with licensure will lead to wrong commercial decisions — about pricing, launch timing and market claims alike.

Insight two: the eligibility criteria directly confirm the licence-first dual-track structure. The Phase 1 eligibility conditions were holding an establishment licence whose licensed activities in South Africa include import or manufacture, and each licensed establishment could nominate only one device. These two design choices anchor the feasibility study firmly to the establishment licence, and they confirm that the establishment licence is the precondition for every future product-level action in South Africa.

Insight three: the Phase 1 shortfall (32 targeted, 22 received) exposed an information gap in the process design. The official reflection concluded that Phase 1 had not provided enough information about the fee structure and timelines, which is precisely why Phase 2 exists. For companies, this points to a reverse opportunity: submitting a complete dossier and documenting the points where the process stalls is, in effect, participating in the making of the rules that will later govern everyone.

Insight four: the Phase 2 category selection previews the priority order of the eventual call-up. From HIV and TB (infectious disease burden) to breast, prostate and lung cancer (oncology burden), SAHPRA’s selections track the structure of South Africa’s disease burden closely. The practical estimate is that if a future call-up proceeds in tranches by risk class and disease area, high-risk devices related to these two disease groups are most likely to be called up first.

Insight five: the costs and benefits of participation must be weighed case by case. The benefits are rehearsing the process, building the relationship with the regulator, and influencing the design of the rules; the costs are real dossier work (classification argumentation, essential principles, technical documentation, clinical evaluation, QMS evidence, labelling and instructions for use, and deficiency-response cycles) with no revenue attached. Participants withdrew midway during Phase 1. Companies with mature dossiers are advised to participate; companies whose dossiers are not yet ready should first finish the dossier.

4. Practical recommendations

1. First confirm eligibility: a valid establishment licence that includes import or manufacture.
2. Check whether the GMDN code is on the EOI list: devices outside the list will be refused.
3. Assess dossier maturity before committing: avoid withdrawing midway through the study.
4. Use the guidance and templates of the current round: do not rely on the old Phase 1 versions.
5. Treat participation as a process rehearsal, not a route to a certificate: keep external messaging accurate.
6. Record process bottlenecks and feed them back: this is where the greatest value of participation lies.

5. Verification checklist

• □ A valid establishment licence including import or manufacture has been confirmed
• □ The GMDN code of the candidate device is on the EOI list
• □ The limit of one device per licensed establishment has been confirmed
• □ Dossier maturity has been assessed (classification, essential principles, technical documentation, clinical, QMS, labelling)
• □ The guidance and templates of the current round have been obtained (not the old Phase 1 versions)
• □ It has been confirmed that participation produces no registration number, and external messaging is aligned
• □ It has been confirmed that participation carries no application fee
• □ A plan exists to record process bottlenecks and feed them back to SAHPRA

Regulatory information verified as of 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the official sources listed in the legal basis section above as published on that date; where official documents have been updated, the most recently published version prevails.

• Local resources in South Africa: GRZAN assists manufacturers from the Chinese mainland and other markets with SAHPRA medical device establishment licence (MDEL) applications and product registration preparation, including authorised representative (AR) scheme design, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification determination, technical documentation, and the setup of vigilance and adverse event notification mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway argumentation, technical documentation and essential principles conformity argumentation, labelling and instructions for use localisation in English, and support for post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.