FAQs – Medical Devices Licencing

If you manufacture, import, export, distribute or if you are a wholesaler of a medical device (including IVD).

Applicants may apply for the type of licence in accordance with the activities being performed at the site, refer to the definition of a manufacturer, distributor and wholesaler on the medical device regulations.

Manufacturer’s Licence (manufacturing, import, distribution, and export activities) (GLF-MD-06A Licence Application to Manufacture Medical Devices)

Manufacture medical devices (including IVDs), including activities such as design, purchasing of material, specification development, production, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labelling and refurbishing of a medical device or IVD, as the case may be, and includes putting a collection of medical devices or IVDs, and possibly other products, together for a medical purpose in accordance with quality assurance and related controls.

Wholesaler’s Licence (Storage and distribution activities) (GLF-MD-06B: Licence Application to Wholesale Medical Devices)

Procuring medical devices from a local manufacturer or distributor and selling retailers (Section 22H). A wholesaler’s licence does not permit importation or exportation of medical devices. A wholesaler may store and export medical devices on behalf of an approved distributor or manufacturer.

Distributor’s Licence (import, distribution, and export activities) (GLF-MD-06C Licence Application to Import, Distribute or Export Medical Devices).

Importing, exporting or distributing medical devices. Distributors who use a third-party storage facilities must ensure that the third-party is a holder of a medical device establishment licence.

Select “Application forms” on the Medical Device homepage

Select and download the applicable licence application form based on the activities performed.

Complete the licence application form in the Microsoft Excel format. Note: Formatting is restricted, the forms are not editable online and applicants must download them in order to complete.

1. Cover Letter:

All applications should be submitted with a cover letter that has been prepared on a company letterhead, signed and dated by the authorised representative.

The cover letter must be addressed to the CEO and marked for the attention of the Medical Device Unit.

The cover letter must indicate the purpose of the submission (i.e. Application for a medical device establishment licence to manufacture, distribute or wholesale medical devices).

The cover letter must include a list of annexures that are submitted with the application, for example:

• Annex 1: Licence Application form
• Annex 2: Proof of Payment
• Annex 3: Curriculum Vitae of the Authorised Representative
• Annex 4: Quality Manual (Manufacturers/Distributors) or Site Master File (Wholesalers)
• Annex 5: Supporting documents (if applicable)
• Annex 6: ISO 13485 accreditation certificate/confirmation letter (if applicable)

2. Application forms:

Completed licence application in Microsoft Excel format

PDF version initialed by the Authorised Representative on each page and signed on the declaration section.

3. Curriculum Vitae of the Authorised Representative

4. The Quality Manual (Manufacturer/Distributor (Importer)) addressing the aspects of the Quality Management System (QMS) https://www.sahpra.org.za/document/guideline-on-medical-device-quality-manual/

4. The Site Master File (Wholesalers)

5. Proof of payment issued by the bank for the licence application in accordance with Regulations Regarding Fees Payable in terms of the Provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 Of 1965) https://www.sahpra.org.za/document/regulations-regarding-fees-payable-in-terms-of-the-provisions-of-the-medicines-and-related-substances-act-1965-act-no-101-of-1965/

6. ISO 13485 accreditation certificate/confirmation letter issued by a conformity assessment body that is recognised by SAHPRA (if applicable) https://www.sahpra.org.za/document/iso-13485-certificate-as-a-prerequisite-for-the-approval-of-a-medical-device-establishment-licence/

7. If the listing includes COVID-19, HIV or Mpox (Monkey Pox) kits (IVDs), submit

• ISO 13485 accreditation certificate issued to the original equipment manufacturer (OEM)
• Evidence of premarket registration from one of the 6 jurisdictions recognised by SAHPRA
• Packaging and labelling information
• Instructions for use of the medical device
• Technical dossier including clinical, validation and stability data
• World Health Organisation prequalification report (If applicable)

mdadmin@sahpra.org.za and CC mdcovid@sahpra.org.za if the application includes COVID-19 testing kits

Timelines for applications is 6-8 weeks from the date of submission and depends on the timeous response by applicants and the submission of sufficient documents. Refer to the process flow on the medical device landing page.

The applicant must ensure that all documents are submitted to minimise the unforeseeable delays on the review of the application; the applicant is required to respond to the deficiencies noted in the observation letter within 2 working days of receiving the communication letter.

Submit an amendment application that includes all the desired changes (including the product listing updates).

The licensee must submit the updated product listing which includes the approved product list from the initial application, in the case that the licensee would like to remove a product from the product list, the licensee must omit this device from the application form.

The recently published version of the application form must be submitted when applying for an amendment.

Submit a notification application to update the product listing. The licensee must submit the updated product listing which includes the approved product list from the initial application, in the case that the licensee would like to remove a product from the product list, the licensee must omit this device from the application form.

The recently published version of the application form must be submitted when applying for a notification.

An amendment is where any changes that an applicant wishes to update will affect the details of the issued licence, such as:

• Change of company/establishment/entity name (where the company registration remains the same)
• Change of address/es
• Change of Authorised Representative
• Change of licence holder
• Change of Authorised Representative or licence holder contact details (telephone number, cell phone number and email address)
• Addition or removal of activities listed
• Change of QC personnel
• Change of supply chain personnel
• Addition to the product list of another class which were not approved on the issued establishment license
• Any other updates arising from incorrect information submitted to the Authority which was indicated on the issued licence

A notification is when an applicant wants to make changes on the application form with information that does not affect the details on the issued licence, such as:

• Updating the product list regarding original manufacturer or supplier details
• Original manufacturer or supplier originating approvals/registrations
• Updating the GMDN codes on the product list
• Updating the name/family or group on the product list
• Adding medical devices to the listing that are the same class in which they already have approval for
• Removing medical devices to the listing without changing the classes in which the licence is approved for

The notification will be subjected to a review and will be approved/rejected, and the licensee will be notified in writing on the outcome.

Addition or removal of COVID-19 or Mpox kits products are regarded as an amendment.

Submit the following documents to mdadmin@sahpra.org.za and cc mdcovid@sahpra.org.za if the application includes COVID-19 testing kits:

• Cover letter (Signed and dated by Authorized Representative) – Attention Medical device Unit. All intended updates/changes must be indicated on the cover letter (e.g. amendment of section X of the application form).
• Application form in excel https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-application-forms/
• Application form in PDF initialed on every page and signed by the authorized representative
• Quality Manual (Manufacturer/Distributor) https://www.sahpra.org.za/document/guideline-on-medical-device-quality-manual/ or Site master file for wholesaler
• ISO 13485 accreditation certificate/confirmation letter issued by a CAB recognised by SAHPRA (if applicable) https://www.sahpra.org.za/document/iso-13485-certificate-as-a-prerequisite-for-the-approval-of-a-medical-device-establishment-licence/
• Proof of payment – https://www.sahpra.org.za/document/regulations-regarding-fees-payable-in-terms-of-the-provisions-of-the-medicines-and-related-substances-act-1965-act-no-101-of-1965/
• CV of Authorized Representative
• Proof of retention fee payments
• Current licence
• Supporting documents for COVID-19 related products (if applicable)

Submit the following documents to mdadmin@sahpra.org.za, the email subject of the notification must state: Notification to update the manufacturer/distributor/wholesaler Licence [Licence no] of [Company name].

• Cover letter: Signed and dated by Authorised Representative – Attention Medical Device Unit which must include a written declaration by the authorised representative indicating that the changes made to the product list (s) do not affect the class of medical device(s) which the licence holder has been approved for.
• Application form: Microsoft Excel format and signed PDF version
• Copy of the licence
• Any other supporting documents (if applicable)

An email request must be sent to mdqueries@sahpra.org.za and indicate the information to be updated. The request will be reviewed to confirm whether it is accepted or not and the outcome will be communicated.

The company must apply for a licence amendment to update details of the Authorised Representative/ Licence Holder.

The renewal application must be submitted without the change as an amendment cannot be submitted with a renewal. The amendment can be submitted once the applicant has been issued the renewed license.

No, the open application must be finalised prior to submission of another application. That is once the applicant has been issued the latest Establishment license.

Applicants will be requested to address deficiencies during the application process. Failure to respond to deficiency letters will result in the application being rejected.

The company must send a cover letter to request withdrawal of the said licence and the reason for withdrawal to mdadmin@sahpra.org.za and cc mdqueries@sahpra.org.za. The cover letter should be prepared on the company letterhead, indicating the company name and licence number and should be signed and dated by the Authorised Representative.

The Cover letter must be addressed to the CEO and marked for the attention of the Medical Device Unit.

Proof of payment for retention fees may be requested from the company before the request is processed.

Yes, through submission for a name change amendment. The company registration number must remain the same for the amendment to be considered.

No. If a licence is already approved and issued to the company, and the company intends to change the licence type, they must submit a new application and pay the application fee. Upon approval of the licence, the company may request to withdraw the initial licence.

No, a medical device establishment licence is not transferable, each applicant must apply for their own licence.

The Manufacturer licence authorises manufacturing, import, distribution, and export activities for medical devices/IVDs.

The Distributor licence authorised import, export and distribution activities for medical devices/IVDs.

The manufacturer’s licence encompasses the distributor’s licence activities, it is not recommended for an applicant to apply for a manufacturer’s licence and distributor’s licence for the same site unless if the intended activities for both licences are different.

The applicant will be liable to pay annual retention fees for both licences if the applicant retains both licences.

Click on the tab “Databases & Registers” at the top right of the homepage and select “Medical Devices Licences Issued”. Search using the licence number indicated on the licence or covering letter or the company name.

If no results are found, contact the Medical Device Unit: mdqueries@sahpra.org.za

The issued observation letter contains the details of the sender, contact the sender through email or phone call to request an extension.

Click on “Operational Units” and select “Medical Devices”. Select “Guidelines” and download the Guideline for Classification of Medical Devices and IVDs

A five (5) digit numeric code and a term, name and definition used for naming, classification and categorisation of all medical devices and IVDs. Include products used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.

No, SAHPRA will continue using GMDN code as it does not exclude non-European countries.

Visit the GMDN Agency website: https://www.gmdnagency.org/, sign in or register to get access. Use the search function to get the correct code and term that aligns with the intended use of the product.

If the period of review has lapsed, such as when there is no response to a query/observation within the stipulated timeframes.

The applicant does not comply with the stipulated specifications, requirements and test reports.

The applicant submits incorrect or falsified information.

As per recommendation from the relevant review committees.

Refers to section 36 of Medicines and Relates Substances Act 101 of 1965, that allows companies to apply for exemptions to the operation of any or all provisions of this Act, under specific conditions or circumstances. Medicines and Related Substances Act 1965, Act No. 101 of 1965, as amended

Applicants must send an email to mdqueries@sahpra.org.za or enquiries@sahpra.org.za OR call the SAHPRA reception landline on (012) 501 0300 OR use the SAHPRA Help Desk https://www.sahpra.org.za/general-enquiries-2/

A Certificate of Free Sale is a certificate, which serves as confirmation that the listed medical devices are legally sold or distributed in the open market in South Africa, freely without restriction and approved by the regulatory authority (SAHPRA) in the country of origin (South Africa). A Certificate of Free Sale may be referred to as a “Certificate for Export” or “Certificate to Foreign Government” in other jurisdictions. The Certificate of Free Sale serves as confirmation by SAHPRA that the manufacturer is licensed by SAHPRA to manufacture medical devices/IVDs and is the original manufacturer of the listed products.

Note: The medical device/s has/have not been assessed for safety and performance by SAHPRA.

The Certificate of Free Sale will be valid for a maximum period of one year in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965).

Refer to the Guideline for Medical Device Certificate of Free Sale https://www.sahpra.org.za/document/guideline-for-medical-device-certificate-of-free-sale/  and access the application form on https://www.sahpra.org.za/document/application-for-certificate-of-free-sale-for-medical-devices/

Escalate to the key contacts on the website https://www.sahpra.org.za/key-contacts/

The license renewal application must be submitted at least 90 days prior to the license expiry date. The current licence can be used to confirm the license expiry date.

Download and complete the recent version of the licence application form on the Medical Device homepage (if applicable).

Submit the following documents to mdadmin@sahpra.org.za or mdcovid@sahpra.org.za

Email subject Establishment License Renewal- Licence number_Company name

• Application forms: Microsoft Excel format and PDF version
• Cover letter: Signed and dated by Authorised Representative – Attention Medical device Unit
• The intention of the application on the subject matter
• List non-exhaustive
• Addition and or subtraction of product listing in relevant tables as per organisation’s activities
• Mention any update made that may affect the information details of the current license (If any)
• List of attachments
• Quality Manual (Manufacturers/Distributors) or Site Master File (Wholesalers)
• Proof of payment (https://www.sahpra.org.za/document/regulations-regarding-fees-payable-in-terms-of-the-provisions-of-the-medicines-and-related-substances-act-1965-act-no-101-of-1965/) – The fee for a medical device establishment licence application renewal is payable upon submission.
• CV of Authorised Representative
• Proof of retention fee payments
• Copy of the licence
• Supporting documents (if any)
• A certified copy of the ISO 13485:2016 (or later)

Changes that are regarded as a notification are permitted during a renewal application and changes that are regarded as an amendment are not permitted during a renewal application.

Renewal applications submitted less than 90 days prior to expiry will not be accepted. Applicants are required to submit a new licence application as the licence will expire while the application is being processed.

Submissions of applications which have superseded the licence expiry date will not be accepted; applicants will be required to submit a new licence application and will be prohibited from trading if the licence is already expired.

Yes, it is only acceptable in two scenarios, one for an authorised representative that acts on behalf of the companies within the same address/province and for companies where the Regulatory oversight is at the head office.

Yes, a company can hold more than one licence based on the activities being performed at the site, payment of retention fees will be applicable for all licences.

No, any changes made after the application is finalised will be considered amendments and the applicant must submit a licence amendment application.

The amendment process must be followed if the shareholder is the authorised representative, licence holder, supply chain or QC personnel.

A certificate issued by the under the International Organisation for Standardization (ISO) to a company that complies with the requirements for regulatory purposes for a medical devices Quality Management Systems (QMS).

Conformity assessment body (CAB) that is recognised by SAHPRA, the list of conformity assessment bodies (CABs) is available on the SAHPRA website https://www.sahpra.org.za/list-of-recognised-conformity-assessment-bodies/.

Please contact mdreg@sahpra.org.za for assistance.

Yes, it will be accepted if the South African establishment has been listed on the certificate.

Ensure that the activities on the application form and issued establishment licence and the submitted quality manual aligns with the ISO 13485 certificate.

Ensure that the activities on the application form and issued establishment licence and the submitted quality manual aligns with the ISO 13485 certificate.

Licence holders who appoints third-parties to perform activities on their behalf must ensure that the third-party company is a holder of medical device establishment licencehttps://www.sahpra.org.za/document/licensing-requirements-for-outsourced-or-contracted-activities-for-medical-device-establishments/.

Yes, the requirement is applicable even in cases where the establishment is exempted from licensing under section 22C of the Medicine Act 101 of 1965.