In a volatile world where everything ups and constantly change, it is imperative for people to feel safe whenever they make a purchase and that is what SAHPRA seeks to achieve as a regulatory body amongst other beneficial mandates in the areas of health.
What Is SAHPRA?
SAHPRA is an abbreviation of South African Health Products Regulatory Authority which is more than just a regulatory entity.
It is an outfit that was specifically birth by the South African government to superintend the management and balancing of health products which may include medical devices, medicines, in-vitro diagnostic tests and devices, radiation-emitting products and any device that may come in handy in the health care industry.
It is a Section 3A, mandated by the Medicines and Related Substance Act, 1995 ((Act No. 101 of 1965) and since its inception has replaced the Medicines Control Council thus MCC and equally the Directorate of Radiation Control thus the DRC. It regulates, monitors, evaluates, investigate, inspects, register and reviews all the above-mentioned products and any that falls within the spectrum and their use in South Africa.
SAHPRA is managed by a board appointed by the Minister of Health whiles the CEO was appointed by the board with consultation with the health ministry. Other managerial positions such as Chief Finance Officer, Director of IT and Secretarial positions have all been filled professionally.
What Is SAHPRA License?
SAHPRA is legally bound to provide licenses to manufacturers, wholesalers and distributors. It is this license that makes any person, persons or companies viable operate respectively in the previously mentioned fields in South Africa.
The SAHPRA License is issued by the medical device unit. It solely regulates medical devices establishments and the registration of devices as well. The motive here is to accurately ensure that these establishments adhere to the acceptable standards of safety, quality and performance.
These licenses are per what is required in Section 22C, Regulation 23 and 24 of the Medicines and Related Substances Act, 1965 ( Act 101 of 1965).
Types Of SAHPRA License
The SAHPRA Licenses come in three folds and one is likely to apply for any one of these three or altogether. The licenses are Medical Device Establishments which spreads across manufacturing, packaging, labelling, service with import and export.
Then there is the Distributor spreading across import, export and distribution and finally, the Wholesale involving storage, transportation and delivery.
According to the codes of SAHPRA, what it stands for and what it has set out to achieve, no medical device should be manufactured, distributed, imported, exported or sold to the general public without a notable and valid SAHPRA license.
It must be noted that it is required of persons or companies who have applied for the SAHPRA Licence to make available a representative who is flesh and blood, that is an authorised person who lives in South Africa as one will be required from every other site the mentioned company operates. The onus will be on this person to live up to the regulatory standards, laws and regulations of SAHPRA in the course of running the company.
Additionally, a company that has applied for a Medical Device Establishment License is expected to present the list of all medical devices it manufactures, distributes and wholesales. Included in the application is a declaration that concerns itself with how management is handling its affairs in terms of quality and conviviality.
How To Apply For SAHPRA License
The SAHPRA license is valid for five years.
First and foremost, to apply for a SAHPRA license, one will need to download the appropriate application form. The form must succinctly be completed by any manufacturer of a medical device who has hopes to manufacture, import and export a medical device. Each site must have a respective application form.
Secondly, SAHPRA will require a Quality Manual which may be printed and added to the completed application form or indicate ‘No’ on the form to be added on a later date.
Thirdly, Medical Device Establishments License forms, regardless of their type should be completed and submitted to SAHPRA in English. Forms are expected to be bound on the left for easy flips and accessibility.
Text size, font and tables should be eligible with an ideal recommendation of Arial 12 point for narrative text or Arial 10 point black on white. Standard A4 should be used for all submissions.
All applications must importantly be submitted with a cover that features the Company’s letterhead signed by the Company’s director, addressed to the registrar, type of license and the content.
As established earlier, one may apply for one of the three types of licenses.
Licensing Application Forms
- Download the Manufacturer Medical Device Establishment Licence application form here.
- Download the Distributor Medical Device Establishment Licence application form here.
- Download the Wholesaler Medical Device Establishment Licence application form here.
SAHPRA has made it known to establishments that manufacture custom devices that it is not required of them to apply for a license nor are they required to present a list of their devices with the accompanying codes.
It must be noted that renewing the SAHPRA license will require manufacturers and distributors to make available evidence of ISO 13485 certification for the company by an accredited conformity assessment body.
License Application Cost For New Or Renewal
SAHPRA has entrenched that it will not provide an invoice or a purchase order. This means that, if a company demands an invoice, they will have to resort to asking them to accept the gazetted fee scheduled together with the cover letter of application.
The fees may be transferred electronically or manually to the bank account of SAHPRA. No cheques are accepted.
As of November 17th 2021, initial registration for SAHPRA license including Radiation control license if applicable was at USD 1010 with the annual fee at USD 282.
Three copies of proof of payment must be added to the three copies of the cover letters.
A letter of acknowledgement will be sent via email from SAHPRA once submission is made and this is to substantiate the license processes are being overseen. `