SAHPRA Certificate of Free Sale: Scope, Limits and Export Use

1. Key takeaways

The Certificate of Free Sale (CFS) is a document issued by SAHPRA certifying that a specific medical device is legally sold in South Africa, with its principal use being to support registration or customs clearance of the product in third countries. The South African CFS application form is GLF-MD-21A (version updated in March 2026). Note in particular: a CFS certifies legal circulation in South Africa and is not equivalent to a SAHPRA product approval or registration certificate — as of the verification date, no product registration numbers exist in South Africa.

The operating logic follows directly: a CFS presupposes a valid Establishment Licence, it covers only products within the licensed product list, fees follow the current SAHPRA tariff and may be adjusted annually, and the document should be described truthfully to importing countries so that it is not mistaken for a product approval.

2. Legal basis

The table below lists the official sources relied upon.

3. Expert insights

Insight 1: The precondition for a CFS is holding a valid Establishment Licence. SAHPRA issues a CFS on the premise that the entity is already operating legally in South Africa, and legal operation presupposes a valid Establishment Licence. A company without a licence cannot obtain a CFS — this is the first link that must be resolved when planning export documentation. Companies that discover this only when a foreign distributor requests export papers lose commercial time; licence planning and CFS planning should therefore be treated as one pipeline rather than two separate tasks.

Insight 2: A CFS is not a product approval and cannot substitute for a registration certificate. Because South Africa has not yet issued product registration call-up notices, the CFS is the closest document to an official product-level attestation that South Africa can currently provide. When submitting it to third countries, companies should state its nature truthfully to avoid it being misread as a SAHPRA product approval. Overstating the effect of the document in distributor agreements or tender submissions creates contractual and regulatory risk, since the certificate itself does not assert product approval.

Insight 3: CFS requirements in the importing country must be checked case by case. Different countries have different requirements for CFS format, issuing authority and notarisation or legalisation. The practical estimate: before applying, confirm with the target country whether it accepts a CFS issued by SAHPRA and whether embassy or consular legalisation is needed, so that a useless document is not produced. Confirming format and legalisation requirements in advance costs one email; re-applying after a rejected submission costs weeks and duplicate fees.

Insight 4: A CFS must be consistent with the status of the product list. A CFS is ordinarily issued for specific products, and those products must be included in the entity’s licensed product list. Products not covered by the list cannot obtain a CFS — which underlines once more the importance of maintaining the product list. Export-driven companies should reconcile their commercial catalogue against the licensed list before taking foreign orders, so that every product promised for export has a regulatory basis for the certificate.

Insight 5: A CFS carries fees, and the current tariff must be checked. South African fees are denominated in rand and adjusted annually; the current SAHPRA tariff prevails, and it should be re-checked before applying rather than relying on historical amounts. Budget holders should also note that legalisation costs in the importing country, if required, sit outside the SAHPRA fee, and that processing plus any legalisation cycle should be built into the delivery schedule for the export transaction.

4. Practical recommendations

The following actions align CFS applications with the regime above.

1. Confirm first that a valid Establishment Licence is held: this is the precondition for issuance.
2. Confirm the product is included in the licensed product list: products outside the list will not be certified.
3. Use the current GLF-MD-21A form (the March 2026 version).
4. Confirm format and legalisation requirements with the importing country before applying: avoid duplicate applications.
5. Describe the nature of the CFS accurately externally: never present it as a product registration certificate.
6. Re-check the current tariff before applying: amounts may be adjusted annually.

5. Verification checklist

Confirm every item below before and during a CFS application.

• □ A valid SAHPRA Establishment Licence has been confirmed
• □ The products for which a CFS is sought are within the licensed product list
• □ The current GLF-MD-21A version (March 2026) has been obtained
• □ The CFS format and legalisation requirements of the importing country have been confirmed
• □ It has been confirmed that the CFS does not substitute for a product registration certificate, and the external wording has been unified
• □ The CFS fee items in the current tariff have been re-checked
• □ The product list and the CFS application content are consistent
• □ Sufficient time has been reserved for processing and any legalisation cycle

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 are subsequently updated, the latest published version prevails.

• South Africa local resources: GRZAN assists manufacturers from the Chinese mainland and overseas 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 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 (English), and post-market vigilance and annual compliance information submission support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.