Reprocessing of Single-Use Medical Devices: SAHPRA MD07-2025/26 Key Requirements

1. Key takeaways

On 29 August 2025 SAHPRA published the communication Reprocessing of Single-Use Medical Devices (MD07-2025/26), regulating whether and how medical devices labelled as single use may be reprocessed. The core principle is that reprocessing is not a default-permitted activity: it may only be carried out within the regulatory framework and on the strength of validation evidence, and the reprocessor bears responsibility for the safety and performance of the reprocessed device once it is put back into use.

2. Legal basis

3. Expert insights

Insight 1: MD07-2025/26 completes a missing piece in South Africa’s device housekeeping framework. The 2016 Notice 1515 already contained device housekeeping content in its structure, and the 2021 draft went further by dedicating provisions to repair, servicing, refurbishment and the use of single-use devices. This shows that reprocessing has long been a concern of the South African system that had not been detailed, and the 2025 communication is its concretisation, giving operators a text they can finally design procedures around. The interval between the 2021 draft and the final communication also gave reprocessors several years of notice that these expectations were coming.

Insight 2: The reprocessor’s responsibility differs from that of the original manufacturer but is no lighter. Once a device labelled for single use is reprocessed and put into use, the reprocessor assumes responsibility for that device’s safety and performance, and must demonstrate conformity on three levels: essential principles conformity, risk management and vigilance reporting. This aligns with the logic, familiar from the EU MDR, that a reprocessor assumes manufacturer-like obligations for the devices it reprocesses. In practical terms this means the reprocessor needs its own technical file for the reprocessed device, not merely access to the original manufacturer’s documentation.

Insight 3: Validation evidence is the core of whether reprocessing can stand. Reprocessing must demonstrate that cleaning, disinfection or sterilisation, functional testing and packaging integrity have all been validated, and that a clearly justified upper limit on the number of reprocessing cycles exists. Practical estimate: the validation protocol and records should be established before reprocessing begins, not reconstructed afterwards when an inspection or an adverse event forces the question. Validation should also cover worst-case loads and the oldest allowable cycle, since those conditions define the safe envelope for reuse.

Insight 4: Reprocessing connects directly to the vigilance system. If an adverse event involves a reprocessed device, the reporting obligation falls on the reprocessor. The three-tier timelines of SAHPGL-MD-03 v4 (48 hours / 10 days / 30 days) apply equally. Reprocessing establishments must build their own vigilance procedures and cannot rely on the original manufacturer’s processes, which were never designed to cover their activities. Reprocessing establishments should therefore register as reporters in their own right and rehearse the escalation path before the first incident occurs.

Insight 5: Labelling and instructions for use must reflect the reprocessing status. Where a reprocessed device is no longer in its original factory single-use state, its labelling and instructions should reflect that fact truthfully. Practical estimate: where relabelling is involved, assess against MD10-2025/26 whether a licence amendment is triggered, since relabelling activities are expressly tied to the amendment route in South Africa. Where a device will be reprocessed repeatedly, the labelling should additionally state the maximum number of cycles allowed.

4. Practical recommendations

1. Obtain the current text of MD07-2025/26 before starting reprocessing: build procedures to the communication’s requirements.
2. Establish a complete reprocessing validation protocol and records: including the justification for cycle limits.
3. Build your own vigilance procedures and reporting channels: the reprocessor is the responsible party.
4. Ensure labels of reprocessed devices truthfully reflect their status: and assess amendment triggers.
5. Integrate reprocessing into the quality management system: ISO 13485 coverage must include the process.
6. Discuss technical feasibility with the original manufacturer: retain records of the communication.

5. Verification checklist

• □ Current text of MD07-2025/26 (2025-08-29) obtained
• □ Reprocessing validation protocol and records established (including cycle limits)
• □ The reprocessor’s safety and performance responsibilities defined internally
• □ Vigilance procedures and reporting channels built in-house (48 hours / 10 days / 30 days)
• □ Labels of reprocessed devices truthfully reflect their status
• □ Relabelling scenarios assessed against MD10-2025/26 for amendment triggers
• □ Reprocessing processes covered within the ISO 13485 quality system
• □ Records of technical communication with the original manufacturer retained

Regulatory information verified as at 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the content published by the official sources listed under Legal basis as at that date; where official documents have been updated, the latest published version prevails.

• South Africa local resource: GRZAN can assist manufacturers from the Chinese mainland and overseas in engaging the South African Health Products Regulatory Authority (SAHPRA) on medical device establishment licence (MDEL) applications and product registration preparation, including authorised representative (AR) scheme design, ISO 13485 certification route planning and CAB selection, GMDN coding and classification determination, technical documentation preparation, and the establishment of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A/B/C/D), establishment licence application and renewal, reliance pathway justification, technical documentation and essential principles conformity argumentation, labelling and instructions-for-use localisation in English, and post-market vigilance and annual compliance information submission support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.