By Simone Rudolph-Shortt


Please CHECK the expiry date of your (5 year) Licence and submit renewals at least 60 days prior to the expiry and retain proof of submission and follow up regularly with the SAHPRA until the new licence has been issued. In February, the South African Health Products Regulatory Authority (SAHPRA) issued a communication to industry on the processes that need to be followed for licence renewal.

How do I apply for a Medical Device Establishment license renewal?

a. To get the application form

i. Visit the South African Health Products Regulatory Authority (SAHPRA) website at www.SAHPRA.org.za.

ii. Click on the tab “Health products” at the top of the page.

iii. Click on the tab “Medical devices”, which is the fourth tab under the health products tab on the SAHPRA’s

home page.

iv. Select “Application Forms”, which is the first link within on the medical devices tab (drop down).

v. Select and download either licence application form:

o 6.21 – Manufacturer’s Licence;

o 6.22 – Distributor’s Licence;

o 6.23 – Wholesaler’s Licence

Prepare the following (not in any particular order) and submit

A cover letter

• All applications should be submitted with a Cover letter that has been prepared on a company letterhead,

Questions and Answers: License Renewal Page 9

Questions and answers: License Renewal 04 02 2022

signed by the authorised representative and it should be dated.

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

Complete application form

Pay application Fees

Supporting documents

Which documents must be submitted ?

a. Step 1: Prepare the cover letter on the company’s letter head. The cover letter must indicate;

a. The intention of the application on the subject matter i.e. RENEWAL (and/or NOTIFICATION of changes) to Licence ### [any AMENDMENT is a separate application done before if time permits or AFTER renewal as SAHPRA can not renew and expired licence]

b. Mention any update made that do not affect the information details of the current License; List non-exhaustive

i. Addition and or subtraction of product listing in relevant tables as per organization’s Activities

c. Mention any update made that may affect the information details of the current license (If any)

d. List of attachments

i. Proof of payment (relevant to the established as published in latest gazette Fees) https://www.sahpra.org.za/wp-content/uploads/2021/01/Published-SAHPRA-Fees.pdf

ii. Completed application form and signed declaration Form Signed and initialled PDF Excel sheet Application

Form for Manufacturers/ Distributor ; Signed and initialled PDF for wholesaler

iii. Quality Manual for Manufacturer /Distributor or Site Master File in case of the Wholesaler

iv. In case the organization already has a Copy of the ISO 13485:2016 – A certified copy

v. Copy of current License

vi. Proof of evidence for payment of retention Fees for FY 2020,2021 and 2022 (as applicable)

vii. QMS declaration document

viii. CV of Authorized Representative

ix. Other relevant supporting documents as applicable

e. Confirmation that there are no changes made to the current activities carried by the organization

B . Step 2: Complete the application Form as per the company activities (business operations)

i. Ensure the form is the same as the latest application form submitted to the Authority

ii. Ensure the form in a PDF format is initialed in each page and Declaration is signed

iii. Share both the PDF and Excel spreadsheet (complete all relevant areas)

c. Step 3: Ensure the following documents are also attached and submitted with the renewal of your establishment

license application [email i. Mdadmin@sahpra.org.za, ii. Mdenquiry@sahpra.org.za, iii. June.searela@sahpra.org.za]

i. Quality Manual (For Manufacturer, Distributor (importer and Export))

ii. Site Master File (For Wholesaler) or Quality Manual

iii. ISO 13485:2016 QMS certificate in the name of the South African licensed medical device establishment

and at the same address .(as applicable)

iv. In case, the organization does not have an ISO 13485:2016 Certificate, a declaration by the Authorised

Representative that the organization has implemented a quality management system aligned to the

ISO143485:2016 standard and that a certified copy of certification to ISO13485:2016 standard will be submitted to

the Authority once acquired and no later than 01 April 2025.

v. CV of Authorized Representative

vi. Proof of payment for retention fees for Year of 2020, 2021 and 2022

vii. Proof of Payment of the Establishment application renewal fee.

viii. Other Supporting document deemed relevant to the application as applicable

d. Step 4: Submission of the application to the authority

a. The license renewal application must be submitted at least 90 days prior to the license expiry date.

b. Submit the application to the authority (SAHPRA) using the following contact details  Mdadmin@sahpra.org.za

c. Large submissions can be submitted via secure electronic document transfer Important to Note: For your email communication please use the following information as email subject:

Establishment License Renewal- XXXXX (i.e., Company name)

It is essential that medtech companies apply for licence renewal at least 60 days in advance of expiry to ensure that the new licence is issued prior to the expiry and the company is not barred from trading. Members can apply in advance of the 60-day period in order to ensure compliance with processes as outlined by SAHPRA. SAHPRA is likely to take a hard stance on companies who fail to renew their licence in time and this could jeopardise the company’s sustainability as trade will be prohibited until the new licence is issued.

As renewals and amendments cannot be processed simultaneously, it is recommend that where possible, companies hold off on amendments to avoid waiting for the amendment to be processed so that they can submit for renewal.

Delays on amendments may result in delays with licence renewal and an amendment will not be granted on an expired licence.

Companies can do a listing update with the renewal as long as it falls within existing classifications on the current Medical Device Establishment Licence.