South Africa medical device regulations

A product-list update may use notification only where no other particulars of the issued establishment licence change and the approved classes remain unaffected. Original-manufacturer/supplier details and same-class product additions may fall within that gate. Submit the signed cover letter, AR declaration that licence/class details are unaffected, latest full application in Excel and PDF, current licence, retention-payment proof, supporting product documents and matching ISO13485 certificate if available. If licence particulars are affected, apply for amendment instead.

If the product is a listed Group III electronic product, the NIRMED guidance requires a new licence application with compliance evidence for a manufacturer/brand change, a new brand/model name, or a different model. Administrative address/contact updates can be sent under the stated existing-licence detail-update route. Assess the actual R1302 listed category: the schedule includes blood-gas analysers, so the gate cannot be excluded solely because a product is an IVD. Local manufacture also includes assembly, preparation, processing, repair or maintenance under the Hazardous Substances Act.

GN5855 of 12 February 2025 exempts the specified establishments dealing only in the described Class A medical devices/IVDs from section22C(1) establishment licensing for three years and repeals the 2024 exemption. Its operative text uses the wording “do not have measuring properties/characteristics and /or are non-sterile”; the 2026 CFS guide gives a separate exempt-applicant evidence route. Check the actual sterile/measuring characteristics and authority treatment rather than treating all Class A products or all IVDs as exempt.

For a Class C or D device/IVD, the licence holder must submit full information within 30 days of a modification or a change in the status/certification of the originating approval supporting its licence application. Recall in that originating market requires immediate notification and recall action; withdrawal requires immediate notification and an agreed withdrawal plan. A corporate, brand or REF project must identify whether its supporting foreign approval actually changes.

A change that affects the approved establishment licence is a fee-bearing amendment under MD10 and the current gazetted establishment-licence amendment tariff. MD09’s qualified product-list-only notification carries no application fee. New-company establishment licensing, approved-licence issuance/collection, retention and CFS are distinct chargeable events; none is a universal product-registration transfer tariff.

For a product-list-only notification within MD09’s conditions, no application fee is applicable. If SAHPRA has not responded or communicated an outcome within 10 working days after submission, the organisation may implement the change only if it does not constitute an amendment or otherwise affect particulars reflected on the licence. SAHPRA may require reclassification as an amendment; ten working days is not deemed approval for a change outside the notification gate.

ZAR 5,500

Per amendment

ZAR 3,500

Per licence

The 2026 CFS guideline applies to South African manufactured medical devices including IVDs for export, with a licensed-manufacturer route and a specific exempt Class A route. Submit GLF-MD-21A, destination/purpose cover letter, current manufacturer/product/GMDN/class particulars, licence and product listing where applicable, supporting conformity/ISO/essential-principles evidence as required and payment proof. Exempt Class A applicants instead supply the exemption declaration, classification rationale and labels/IFU/marketing evidence. Current manufacturer and product identities must match the requested certificate; a foreign product import change alone does not establish eligibility for a South African CFS.

Where all CFS requirements are met, SAHPRA’s 2026 guideline states issue within 15 working days. Incomplete applications are not finalised until deficiencies are addressed; the applicant must respond within two working days and only two review opportunities are allowed. The certificate is valid for 12 months from issue. This CFS clock does not govern amendment, product registration, NIRMED or corporate-succession decisions.

An IVD label must carry the name/trade name, product description/intended use, catalogue code where applicable, manufacturer name/business address, holder-of-registration name/business address and the other prescribed traceability/safety particulars. It must be in at least English. Catalogue code is an expressly distinct label field; an orderable REF does not by itself establish a new model or UDI. Reagents separately supplied from a kit must individually comply.

A product-list update may use notification only where no other particulars of the issued establishment licence change and the approved classes remain unaffected. Original-manufacturer/supplier details and same-class product additions may fall within that gate. Submit the signed cover letter, AR declaration that licence/class details are unaffected, latest full application in Excel and PDF, current licence, retention-payment proof, supporting product documents and matching ISO13485 certificate if available. If licence particulars are affected, apply for amendment instead.

If the product is a listed Group III electronic product, the NIRMED guidance requires a new licence application with compliance evidence for a manufacturer/brand change, a new brand/model name, or a different model. Administrative address/contact updates can be sent under the stated existing-licence detail-update route. Assess the actual R1302 listed category: the schedule includes blood-gas analysers, so the gate cannot be excluded solely because a product is an IVD. Local manufacture also includes assembly, preparation, processing, repair or maintenance under the Hazardous Substances Act.

GN5855 of 12 February 2025 exempts the specified establishments dealing only in the described Class A medical devices/IVDs from section22C(1) establishment licensing for three years and repeals the 2024 exemption. Its operative text uses the wording “do not have measuring properties/characteristics and /or are non-sterile”; the 2026 CFS guide gives a separate exempt-applicant evidence route. Check the actual sterile/measuring characteristics and authority treatment rather than treating all Class A products or all IVDs as exempt.

A company/establishment/entity-name change where the company registration remains the same is an establishment amendment. A South African establishment licence is not transferable to another company: each new applicant must obtain its own licence. An overseas original-manufacturer change that leaves all local licence particulars unchanged must instead be assessed under the product-list gate, with its updated supporting evidence; these are distinct roles.

For a Class C or D device/IVD, the licence holder must submit full information within 30 days of a modification or a change in the status/certification of the originating approval supporting its licence application. Recall in that originating market requires immediate notification and recall action; withdrawal requires immediate notification and an agreed withdrawal plan. A corporate, brand or REF project must identify whether its supporting foreign approval actually changes.

A change that affects the approved establishment licence is a fee-bearing amendment under MD10 and the current gazetted establishment-licence amendment tariff. MD09’s qualified product-list-only notification carries no application fee. New-company establishment licensing, approved-licence issuance/collection, retention and CFS are distinct chargeable events; none is a universal product-registration transfer tariff.

For a product-list-only notification within MD09’s conditions, no application fee is applicable. If SAHPRA has not responded or communicated an outcome within 10 working days after submission, the organisation may implement the change only if it does not constitute an amendment or otherwise affect particulars reflected on the licence. SAHPRA may require reclassification as an amendment; ten working days is not deemed approval for a change outside the notification gate.

ZAR 5,500

Per amendment

ZAR 3,500

Per licence

All intended amendment changes must be stated in the cover letter and the updated full product listing includes approved products, with products intended for removal omitted as instructed. A further amendment may not be submitted while a prior amendment is pending. Product-list notifications may accompany renewal if the licence particulars and approved class do not change; amendments to company/entity/address/AR/holder/activities/personnel or new class must be filed after renewal is complete and the latest licence is issued.

The 2026 CFS guideline applies to South African manufactured medical devices including IVDs for export, with a licensed-manufacturer route and a specific exempt Class A route. Submit GLF-MD-21A, destination/purpose cover letter, current manufacturer/product/GMDN/class particulars, licence and product listing where applicable, supporting conformity/ISO/essential-principles evidence as required and payment proof. Exempt Class A applicants instead supply the exemption declaration, classification rationale and labels/IFU/marketing evidence. Current manufacturer and product identities must match the requested certificate; a foreign product import change alone does not establish eligibility for a South African CFS.

Where all CFS requirements are met, SAHPRA’s 2026 guideline states issue within 15 working days. Incomplete applications are not finalised until deficiencies are addressed; the applicant must respond within two working days and only two review opportunities are allowed. The certificate is valid for 12 months from issue. This CFS clock does not govern amendment, product registration, NIRMED or corporate-succession decisions.

An IVD label must carry the name/trade name, product description/intended use, catalogue code where applicable, manufacturer name/business address, holder-of-registration name/business address and the other prescribed traceability/safety particulars. It must be in at least English. Catalogue code is an expressly distinct label field; an orderable REF does not by itself establish a new model or UDI. Reagents separately supplied from a kit must individually comply.

A product-list update may use notification only where no other particulars of the issued establishment licence change and the approved classes remain unaffected. Original-manufacturer/supplier details and same-class product additions may fall within that gate. Submit the signed cover letter, AR declaration that licence/class details are unaffected, latest full application in Excel and PDF, current licence, retention-payment proof, supporting product documents and matching ISO13485 certificate if available. If licence particulars are affected, apply for amendment instead.

If the product is a listed Group III electronic product, the NIRMED guidance requires a new licence application with compliance evidence for a manufacturer/brand change, a new brand/model name, or a different model. Administrative address/contact updates can be sent under the stated existing-licence detail-update route. Assess the actual R1302 listed category: the schedule includes blood-gas analysers, so the gate cannot be excluded solely because a product is an IVD. Local manufacture also includes assembly, preparation, processing, repair or maintenance under the Hazardous Substances Act.

GN5855 of 12 February 2025 exempts the specified establishments dealing only in the described Class A medical devices/IVDs from section22C(1) establishment licensing for three years and repeals the 2024 exemption. Its operative text uses the wording “do not have measuring properties/characteristics and /or are non-sterile”; the 2026 CFS guide gives a separate exempt-applicant evidence route. Check the actual sterile/measuring characteristics and authority treatment rather than treating all Class A products or all IVDs as exempt.

A company/establishment/entity-name change where the company registration remains the same is an establishment amendment. A South African establishment licence is not transferable to another company: each new applicant must obtain its own licence. An overseas original-manufacturer change that leaves all local licence particulars unchanged must instead be assessed under the product-list gate, with its updated supporting evidence; these are distinct roles.

For a Class C or D device/IVD, the licence holder must submit full information within 30 days of a modification or a change in the status/certification of the originating approval supporting its licence application. Recall in that originating market requires immediate notification and recall action; withdrawal requires immediate notification and an agreed withdrawal plan. A corporate, brand or REF project must identify whether its supporting foreign approval actually changes.

A change that affects the approved establishment licence is a fee-bearing amendment under MD10 and the current gazetted establishment-licence amendment tariff. MD09’s qualified product-list-only notification carries no application fee. New-company establishment licensing, approved-licence issuance/collection, retention and CFS are distinct chargeable events; none is a universal product-registration transfer tariff.

For a product-list-only notification within MD09’s conditions, no application fee is applicable. If SAHPRA has not responded or communicated an outcome within 10 working days after submission, the organisation may implement the change only if it does not constitute an amendment or otherwise affect particulars reflected on the licence. SAHPRA may require reclassification as an amendment; ten working days is not deemed approval for a change outside the notification gate.

ZAR 5,500

Per amendment

ZAR 3,500

Per licence

All intended amendment changes must be stated in the cover letter and the updated full product listing includes approved products, with products intended for removal omitted as instructed. A further amendment may not be submitted while a prior amendment is pending. Product-list notifications may accompany renewal if the licence particulars and approved class do not change; amendments to company/entity/address/AR/holder/activities/personnel or new class must be filed after renewal is complete and the latest licence is issued.

The 2026 CFS guideline applies to South African manufactured medical devices including IVDs for export, with a licensed-manufacturer route and a specific exempt Class A route. Submit GLF-MD-21A, destination/purpose cover letter, current manufacturer/product/GMDN/class particulars, licence and product listing where applicable, supporting conformity/ISO/essential-principles evidence as required and payment proof. Exempt Class A applicants instead supply the exemption declaration, classification rationale and labels/IFU/marketing evidence. Current manufacturer and product identities must match the requested certificate; a foreign product import change alone does not establish eligibility for a South African CFS.

Where all CFS requirements are met, SAHPRA’s 2026 guideline states issue within 15 working days. Incomplete applications are not finalised until deficiencies are addressed; the applicant must respond within two working days and only two review opportunities are allowed. The certificate is valid for 12 months from issue. This CFS clock does not govern amendment, product registration, NIRMED or corporate-succession decisions.

An IVD label must carry the name/trade name, product description/intended use, catalogue code where applicable, manufacturer name/business address, holder-of-registration name/business address and the other prescribed traceability/safety particulars. It must be in at least English. Catalogue code is an expressly distinct label field; an orderable REF does not by itself establish a new model or UDI. Reagents separately supplied from a kit must individually comply.

A product-list update may use notification only where no other particulars of the issued establishment licence change and the approved classes remain unaffected. Original-manufacturer/supplier details and same-class product additions may fall within that gate. Submit the signed cover letter, AR declaration that licence/class details are unaffected, latest full application in Excel and PDF, current licence, retention-payment proof, supporting product documents and matching ISO13485 certificate if available. If licence particulars are affected, apply for amendment instead.

If the product is a listed Group III electronic product, the NIRMED guidance requires a new licence application with compliance evidence for a manufacturer/brand change, a new brand/model name, or a different model. Administrative address/contact updates can be sent under the stated existing-licence detail-update route. Assess the actual R1302 listed category: the schedule includes blood-gas analysers, so the gate cannot be excluded solely because a product is an IVD. Local manufacture also includes assembly, preparation, processing, repair or maintenance under the Hazardous Substances Act.

GN5855 of 12 February 2025 exempts the specified establishments dealing only in the described Class A medical devices/IVDs from section22C(1) establishment licensing for three years and repeals the 2024 exemption. Its operative text uses the wording “do not have measuring properties/characteristics and /or are non-sterile”; the 2026 CFS guide gives a separate exempt-applicant evidence route. Check the actual sterile/measuring characteristics and authority treatment rather than treating all Class A products or all IVDs as exempt.

For a Class C or D device/IVD, the licence holder must submit full information within 30 days of a modification or a change in the status/certification of the originating approval supporting its licence application. Recall in that originating market requires immediate notification and recall action; withdrawal requires immediate notification and an agreed withdrawal plan. A corporate, brand or REF project must identify whether its supporting foreign approval actually changes.

A change that affects the approved establishment licence is a fee-bearing amendment under MD10 and the current gazetted establishment-licence amendment tariff. MD09’s qualified product-list-only notification carries no application fee. New-company establishment licensing, approved-licence issuance/collection, retention and CFS are distinct chargeable events; none is a universal product-registration transfer tariff.

For a product-list-only notification within MD09’s conditions, no application fee is applicable. If SAHPRA has not responded or communicated an outcome within 10 working days after submission, the organisation may implement the change only if it does not constitute an amendment or otherwise affect particulars reflected on the licence. SAHPRA may require reclassification as an amendment; ten working days is not deemed approval for a change outside the notification gate.

ZAR 5,500

Per amendment

ZAR 3,500

Per licence

All intended amendment changes must be stated in the cover letter and the updated full product listing includes approved products, with products intended for removal omitted as instructed. A further amendment may not be submitted while a prior amendment is pending. Product-list notifications may accompany renewal if the licence particulars and approved class do not change; amendments to company/entity/address/AR/holder/activities/personnel or new class must be filed after renewal is complete and the latest licence is issued.

The 2026 CFS guideline applies to South African manufactured medical devices including IVDs for export, with a licensed-manufacturer route and a specific exempt Class A route. Submit GLF-MD-21A, destination/purpose cover letter, current manufacturer/product/GMDN/class particulars, licence and product listing where applicable, supporting conformity/ISO/essential-principles evidence as required and payment proof. Exempt Class A applicants instead supply the exemption declaration, classification rationale and labels/IFU/marketing evidence. Current manufacturer and product identities must match the requested certificate; a foreign product import change alone does not establish eligibility for a South African CFS.

Where all CFS requirements are met, SAHPRA’s 2026 guideline states issue within 15 working days. Incomplete applications are not finalised until deficiencies are addressed; the applicant must respond within two working days and only two review opportunities are allowed. The certificate is valid for 12 months from issue. This CFS clock does not govern amendment, product registration, NIRMED or corporate-succession decisions.

An IVD label must carry the name/trade name, product description/intended use, catalogue code where applicable, manufacturer name/business address, holder-of-registration name/business address and the other prescribed traceability/safety particulars. It must be in at least English. Catalogue code is an expressly distinct label field; an orderable REF does not by itself establish a new model or UDI. Reagents separately supplied from a kit must individually comply.

A product-list update may use notification only where no other particulars of the issued establishment licence change and the approved classes remain unaffected. Original-manufacturer/supplier details and same-class product additions may fall within that gate. Submit the signed cover letter, AR declaration that licence/class details are unaffected, latest full application in Excel and PDF, current licence, retention-payment proof, supporting product documents and matching ISO13485 certificate if available. If licence particulars are affected, apply for amendment instead.

If the product is a listed Group III electronic product, the NIRMED guidance requires a new licence application with compliance evidence for a manufacturer/brand change, a new brand/model name, or a different model. Administrative address/contact updates can be sent under the stated existing-licence detail-update route. Assess the actual R1302 listed category: the schedule includes blood-gas analysers, so the gate cannot be excluded solely because a product is an IVD. Local manufacture also includes assembly, preparation, processing, repair or maintenance under the Hazardous Substances Act.

GN5855 of 12 February 2025 exempts the specified establishments dealing only in the described Class A medical devices/IVDs from section22C(1) establishment licensing for three years and repeals the 2024 exemption. Its operative text uses the wording “do not have measuring properties/characteristics and /or are non-sterile”; the 2026 CFS guide gives a separate exempt-applicant evidence route. Check the actual sterile/measuring characteristics and authority treatment rather than treating all Class A products or all IVDs as exempt.

A company/establishment/entity-name change where the company registration remains the same is an establishment amendment. A South African establishment licence is not transferable to another company: each new applicant must obtain its own licence. An overseas original-manufacturer change that leaves all local licence particulars unchanged must instead be assessed under the product-list gate, with its updated supporting evidence; these are distinct roles.

For a Class C or D device/IVD, the licence holder must submit full information within 30 days of a modification or a change in the status/certification of the originating approval supporting its licence application. Recall in that originating market requires immediate notification and recall action; withdrawal requires immediate notification and an agreed withdrawal plan. A corporate, brand or REF project must identify whether its supporting foreign approval actually changes.

A change that affects the approved establishment licence is a fee-bearing amendment under MD10 and the current gazetted establishment-licence amendment tariff. MD09’s qualified product-list-only notification carries no application fee. New-company establishment licensing, approved-licence issuance/collection, retention and CFS are distinct chargeable events; none is a universal product-registration transfer tariff.

For a product-list-only notification within MD09’s conditions, no application fee is applicable. If SAHPRA has not responded or communicated an outcome within 10 working days after submission, the organisation may implement the change only if it does not constitute an amendment or otherwise affect particulars reflected on the licence. SAHPRA may require reclassification as an amendment; ten working days is not deemed approval for a change outside the notification gate.

ZAR 5,500

Per amendment

ZAR 3,500

Per licence

ZAR 26,200

Per establishment licence

ZAR 15,600

Per establishment licence

All intended amendment changes must be stated in the cover letter and the updated full product listing includes approved products, with products intended for removal omitted as instructed. A further amendment may not be submitted while a prior amendment is pending. Product-list notifications may accompany renewal if the licence particulars and approved class do not change; amendments to company/entity/address/AR/holder/activities/personnel or new class must be filed after renewal is complete and the latest licence is issued.

The 2026 CFS guideline applies to South African manufactured medical devices including IVDs for export, with a licensed-manufacturer route and a specific exempt Class A route. Submit GLF-MD-21A, destination/purpose cover letter, current manufacturer/product/GMDN/class particulars, licence and product listing where applicable, supporting conformity/ISO/essential-principles evidence as required and payment proof. Exempt Class A applicants instead supply the exemption declaration, classification rationale and labels/IFU/marketing evidence. Current manufacturer and product identities must match the requested certificate; a foreign product import change alone does not establish eligibility for a South African CFS.

Where all CFS requirements are met, SAHPRA’s 2026 guideline states issue within 15 working days. Incomplete applications are not finalised until deficiencies are addressed; the applicant must respond within two working days and only two review opportunities are allowed. The certificate is valid for 12 months from issue. This CFS clock does not govern amendment, product registration, NIRMED or corporate-succession decisions.

An IVD label must carry the name/trade name, product description/intended use, catalogue code where applicable, manufacturer name/business address, holder-of-registration name/business address and the other prescribed traceability/safety particulars. It must be in at least English. Catalogue code is an expressly distinct label field; an orderable REF does not by itself establish a new model or UDI. Reagents separately supplied from a kit must individually comply.

A product-list update may use notification only where no other particulars of the issued establishment licence change and the approved classes remain unaffected. Original-manufacturer/supplier details and same-class product additions may fall within that gate. Submit the signed cover letter, AR declaration that licence/class details are unaffected, latest full application in Excel and PDF, current licence, retention-payment proof, supporting product documents and matching ISO13485 certificate if available. If licence particulars are affected, apply for amendment instead.

If the product is a listed Group III electronic product, the NIRMED guidance requires a new licence application with compliance evidence for a manufacturer/brand change, a new brand/model name, or a different model. Administrative address/contact updates can be sent under the stated existing-licence detail-update route. Assess the actual R1302 listed category: the schedule includes blood-gas analysers, so the gate cannot be excluded solely because a product is an IVD. Local manufacture also includes assembly, preparation, processing, repair or maintenance under the Hazardous Substances Act.

GN5855 of 12 February 2025 exempts the specified establishments dealing only in the described Class A medical devices/IVDs from section22C(1) establishment licensing for three years and repeals the 2024 exemption. Its operative text uses the wording “do not have measuring properties/characteristics and /or are non-sterile”; the 2026 CFS guide gives a separate exempt-applicant evidence route. Check the actual sterile/measuring characteristics and authority treatment rather than treating all Class A products or all IVDs as exempt.

A company/establishment/entity-name change where the company registration remains the same is an establishment amendment. A South African establishment licence is not transferable to another company: each new applicant must obtain its own licence. An overseas original-manufacturer change that leaves all local licence particulars unchanged must instead be assessed under the product-list gate, with its updated supporting evidence; these are distinct roles.

For a Class C or D device/IVD, the licence holder must submit full information within 30 days of a modification or a change in the status/certification of the originating approval supporting its licence application. Recall in that originating market requires immediate notification and recall action; withdrawal requires immediate notification and an agreed withdrawal plan. A corporate, brand or REF project must identify whether its supporting foreign approval actually changes.

A change that affects the approved establishment licence is a fee-bearing amendment under MD10 and the current gazetted establishment-licence amendment tariff. MD09’s qualified product-list-only notification carries no application fee. New-company establishment licensing, approved-licence issuance/collection, retention and CFS are distinct chargeable events; none is a universal product-registration transfer tariff.

For a product-list-only notification within MD09’s conditions, no application fee is applicable. If SAHPRA has not responded or communicated an outcome within 10 working days after submission, the organisation may implement the change only if it does not constitute an amendment or otherwise affect particulars reflected on the licence. SAHPRA may require reclassification as an amendment; ten working days is not deemed approval for a change outside the notification gate.

ZAR 5,500

Per amendment

ZAR 3,500

Per licence

ZAR 26,200

Per establishment licence

ZAR 15,600

Per establishment licence

All intended amendment changes must be stated in the cover letter and the updated full product listing includes approved products, with products intended for removal omitted as instructed. A further amendment may not be submitted while a prior amendment is pending. Product-list notifications may accompany renewal if the licence particulars and approved class do not change; amendments to company/entity/address/AR/holder/activities/personnel or new class must be filed after renewal is complete and the latest licence is issued.

The 2026 CFS guideline applies to South African manufactured medical devices including IVDs for export, with a licensed-manufacturer route and a specific exempt Class A route. Submit GLF-MD-21A, destination/purpose cover letter, current manufacturer/product/GMDN/class particulars, licence and product listing where applicable, supporting conformity/ISO/essential-principles evidence as required and payment proof. Exempt Class A applicants instead supply the exemption declaration, classification rationale and labels/IFU/marketing evidence. Current manufacturer and product identities must match the requested certificate; a foreign product import change alone does not establish eligibility for a South African CFS.

Where all CFS requirements are met, SAHPRA’s 2026 guideline states issue within 15 working days. Incomplete applications are not finalised until deficiencies are addressed; the applicant must respond within two working days and only two review opportunities are allowed. The certificate is valid for 12 months from issue. This CFS clock does not govern amendment, product registration, NIRMED or corporate-succession decisions.

An IVD label must carry the name/trade name, product description/intended use, catalogue code where applicable, manufacturer name/business address, holder-of-registration name/business address and the other prescribed traceability/safety particulars. It must be in at least English. Catalogue code is an expressly distinct label field; an orderable REF does not by itself establish a new model or UDI. Reagents separately supplied from a kit must individually comply.