SAMED has send submissions on the Health Department’s updated draft Medical Device Regulations and the draft SAHPRA fees for health products that were due by 24 November and 3 November 2023 respectively.
The key message in SAMED’s comments is that these regulations must be amended in order to reduce significant risks to all stakeholders across the healthcare system – medtech suppliers, procurers and users, healthcare providers and patients alike.
The product registration process is due to commence soon, and by staying so closely involved with these regulatory developments, SAMED is striving to prevent registration delays and technologies being either temporarily or permanently removed from the market.
We believe that this effort needs member and stakeholder support, giving all of us a valuable opportunity to ensure that the final regulations are sustainable, fit-for-purpose and that they do not compromise the availability of and access to life-improving and lifesaving medtech.
An example of the regulations that require careful consideration is how will the registration of the same medical device by multiple distributors be handled. It is redundant and inefficient for the same technical information to be submitted multiple times to SAHPRA by different suppliers and it might also create the risk of differing outcomes.
SAMED would like to highlight that in this latest submission, we have also acknowledged where previously made comments have been taken into account and addressed in the latest draft. This is an important example of the value of us working together with SAHPRA and SAMED and members making use of opportunities to provide inputs on matters that impact on the suppliers and the sector.
Potential effect of draft Medical Device Regulations on suppliers, procurers , users
| Clause / Section | Possible effect/risk |
|---|---|
| Labelling
Registration number of device on the box Name and physical address of licence holder Name and physical address of registration certificate holder |
A special label/IFU version will add complexity and cost to the supply chain for South Africa and will potentially result in the closure of medical device businesses.
This could result in limiting supply of medical devices to South Africa, and loss of access to technology for patients. It will not add to the safety or performance of any medical device. Some medical devices might be removed from the market. |
| Instructions for use (IFU)
Registration number of the device/IVD on the IFU Name and physical address of licence holder Name and physical address of original manufacturer Name and physical address of registration certificate holder |
A special label/IFU version will add complexity and cost to the supply chain for South Africa and will potentially result in the closure of medical device businesses. This could result in limiting supply of medical devices to South Africa, and loss of access to technology for patients. It will not add to the safety or performance of any medical device.
Some medical devices might be removed from the market. |
| Instructions for use (IFU)
Must appear on or be attached to packed device including all warnings, storage instructions etc |
Draft regulations do not clearly indicate the possibility of electronic IFU applicable to some products.
Some medical devices might be removed from the market. |
| Instructions for use (IFU)
Must appear on or be attached to packed device including all warnings, storage instructions etc |
Draft regulations do not clearly indicate the possibility of electronic IFU applicable to some products.
Some medical devices might be removed from the market. |
| 15 (3) A person who maintains a medical device must keep record of such maintenance and on request, make the records available to the Authority | This duty will fall on the procurer if the procurer selects to undertake own maintenance.
Penalties for non-compliance. |
| Destruction of a medical device
Destruction must be compliant with the legislature |
Destruction activities are usually undertaken by the user (healthcare practitioner or patient) and/or the procurer. They would need to understand how to dispose of medtech in a manner that is aligned with the revised regulations.
Penalties for non-compliance. |
| Vigilance | Healthcare providers and device users including patients will need to inform the holder of the licence or SAHPRA of various vigilance requirements including suspected adverse events, safety, performance or quality concerns.
This will need adequate user education. |
| Record of implants | Records must be kept by the health establishment or healthcare provider for long-term and custom-implanted Class D medical devices for a period of at least five years beyond the expected life of the device.
Lack of patient traceability could risk patient safety. |
Understanding and responding to draft fees
The proposed fees published for comment include increases to existing fees and new product registration fees for medical technologies that the suppliers will not be able to absorb. For context, a similar approach was applied to pharmaceutical fees and might cause comparable challenges in that sector.
The issues raised in SAMED’s submission include:
- These new/increased fees are in addition to costs associated with implementing and being audited against ISO 13485. Medtech suppliers will have to fulfil this requirement in the next two years.
- The anticipated impacts relate to the sustainability of medtech suppliers, product cost/price (ie inflation), product availability due to lines being discontinued to cut operational expenses and more complex progress on innovation and localisation of medtech.
- The high rate of new medtech entering the market might be stifled. For instance, between January and August 2023, over 17000 new NAPPI codes were introduced and mainly for medtech. Suppliers may not feel as incentivised to bring new products to our market when they have to contend with increased and new charges.
Ultimately, upcoming challenges foreseen by SAMED include reduced competition, patient access and healthcare providers’ ability to provide safe and quality services.
Tables contain proposed medtech fees to assist members and stakeholders in appraising the situation and formulating their strategy and operational plans. Please note quantum increases are all rounded.
| Fees payable to the CEO of SAHPRA or Director General of Health | Proposed fee | Quantum increase |
|---|---|---|
| Application for all priority review assessment: Fee charged for a declined priority review application | R 11,500 | New Fee |
| Request for an application number (per number) | R 2,000 | New Fee |
| Request for a borderline product status review | R 15,000 | New Fee |
| Fees for clinical trials | Current fee | Proposed fee | Quantum increase |
|---|---|---|---|
| Safety and efficacy application | R 33,400 | R 33,700 | 1% |
| Phase 4 Clinical Trial | R 5,000 | R 5,100 | 2% |
| S21 technical amendments (per amendment) | R 7,000 | R 7,200 | 3% |
| S21 admin amendment (per amendment) | R 4,100 | R 4,200 | 2% |
| Inspection fees | Current fee | Proposed fee | Quantum increase |
|---|---|---|---|
| Inspection fee for scheduled on-site inspections (per hour) | R 1,600 | R 1,660 | 4% |
| Desktop inspection (per inspector, per day) | R 2,100 | R 2,200 | 5% |
| Permit and certificate fees | Current fee | Proposed fee | Quantum increase |
|---|---|---|---|
| GMP or Free Sale Certificate | R 1,400 | R 1,460 | 4% |
| Import permit | R 950 | R 990 | 4% |
| Export permit | R 925 | R 960 | 4% |
| Any other permit or certificate | R 950 | R 990 | 4% |
| Section 22A permits | R 950 | R 990 | 4% |
| Review of port health or border detainment products | R 400 | New Fee |
| Transfers and appeals | Current fee | Proposed fee | Quantum increase |
|---|---|---|---|
| Transfer of registration | R 1,050 | R 1,100 | 5% |
| Appeals against authority decision | R 50,000 | R 52,500 | 5% |
| Licence fees | Current fee | Proposed fee | Quantum increase | |
|---|---|---|---|---|
| Manufacturer | New Licence | R 25,200 | R 26,200 | 4% |
| Renewal | R 22,000 | R 22,900 | 4% | |
| Distributer | New Licence | R 15,000 | R 15,600 | 4% |
| Renewal | R 12,600 | R 13,100 | 4% | |
| Wholesaler | New Licence | R 15,000 | R 15,600 | 4% |
| Renewal | R 12,600 | R 13,100 | 4% | |
| Other licence fees | Retention | R 4,200 | R 4,400 | 5% |
| Issuing | R 3,400 | R 3,500 | 3% | |
| Amendments | R 5,300 | R 5,500 | 4% |
| Medical device and IVD registration fees | Class A | Class B | Class C | Class D | Quantum increase |
|---|---|---|---|---|---|
| Reliance | R 6,500 | R 14,700 | R 17,400 | R 20,100 | New Fee |
| Full assessment | R 28,900 | R 62,800 | R 69,700 | R 85,100 | New Fee |
| Approval | R 2,000 | R 2,000 | R 2,000 | R 2,000 | New Fee |
| Amendment notification | R 800 | R 800 | R 800 | R 800 | New Fee |
| Prior approval amendment | R 6,100 | R 6,100 | R 6,100 | R 6,100 | New Fee |
| Admin amendment | R 3,000 | R 3,000 | R 3,000 | R 3,000 | New Fee |
| Annual retention | R 5,200 | R 5,200 | R 5,200 | R 5,200 | New Fee |
| Transfer (from medicines) | R 1,800 | R 1,800 | R 1,800 | R 1,800 | New Fee |
| Evaluation reclassification | R 16,600 | R 16,600 | R 16,600 | R 16,600 | New Fee |
| Evaluation deviations | R 5,500 | R 5,500 | R 5,500 | R 5,500 | New Fee |
