Medical device registration in South Africa is governed under the provision of the Medicines and Related Substances Act of 1965. All the manufacturers, importers and distributors are therefore advised to adhere to the rules and regulations laid in the act in order to get the medical device registration in South Africa.
The aim of the Medical Device Establishment Licence is to help the South African Health Products Regulatory Authority in maintaining the record of:
- All the manufacturers of medical devices within the country;
- All the importers and distributors of medical devices within the country.
- Along with this, Medical Device Establishment Licence helps in classifying the medical devices and IVDs as per their risk assessment and intended use.
In the recent course of action, all the domestic medical device manufacturers and distributors were asked to register by August 2017. Similarly, all the domestic wholesalers were required to register by February 2018 and all foreign companies we required to obtain MCC licenses.
Before you enter into the medical device market, you must question yourself on the following aspects:
- What is the ultimate use of your device?
- What is the market potential of your device?
- Is your device patentable?
- What are the regulatory requirements regarding your device?
- Does the medical device address the current needs of the society?
Medical device definition as per South African laws
As per the provisions of the Act a medical device is an instrument, apparatus, implant, implement, machine, appliance, reagent for in vitro use, software, material or other similar or related article used by a manufacturer alone or in s combination for the better health of human beings or for the purposes as mentioned below:
- Diagnosis, prevention, monitoring, treatment/alleviation of disease;
- Diagnosis, monitoring, treatment, of an injury;
- Investigation, replacement, modification/support of the anatomy or of a physiological process;
- Supporting or sustaining a life;
- Controlling conception;
- Disinfection of medical devices.
Classification Rules of Medical Devices in South Africa
All the medical devices in South Africa are classified in four (4) categories, as described below:
|Classification||Level of risk|
|Class A||Low risk|
|Class B||Low–moderate risk|
|Class C||Moderate – high risk|
|Class D||High risk Where risk relates to the patient or to public health|
Medicines and Related Substances Control Act of 1965
Before we jump on medical device registration in South Africa, here are some of the important sections under the act that you must know.
- Section 2 of the talks act about the establishment of South African health products regulatory authority
- Section 2A of the talks act about the objects of authority
- Section 2B of the talks act about the functions of authority
- Section 2C of the talks act about the composition of board
- Section 14 of the talks act about the prohibition on the sale of medicines, medical devices/IVDs which are subject to registration & are not registered
- Section 15 of the talks act about the registration of medicines, medical devices or IVDs
- Section 15A of the talks act about the amendment of entries in register
- Section 15B of the talks act about the transfer of certificate of registration
- Section 15C of the talks act about the measures to make sure the supply of more affordable medicines
- Section 16 of the talks act about the cancellation of registration
- Section 17 of the talks act about the notification of registration or cancellation thereof
- Section 18 of the talks act about the labels and advertisements
- Section 18B of the talks act about the sampling of medicines, medical devices or IVDs
- Section 18C of the talks act about the marketing of medicines, medical devices or IVDs
- Section 19 of the talks act about the prohibition on sale of medicines, medical devices/IVDs which don’t comply with prescribed requirements & furnishing of information regarding medicines, medical devices/IVDs to the Authority
- Section 20 of the talks act about the publication/distribution of false advertisements concerning medicines, medical devices/IVDs
- Section 21 of the talks act about the authority may authorize sale of unregistered medicines, medical devices or IVDs for certain purposes
- Section 22 of the talks act about the authority to cause certain information to be furnished
- Section 22A of the talks act about the control of medicines, Scheduled substances, medical devices & IVDs
- Section 22B of the talks act about the publication of information relating to medicines, scheduled substances, medical devices/IVDs
- Section 22C of the talks act about the licensing
- Section 22D of the talks act about the period of validity and renewal of licence
- Section 22E of the talks act about the suspension and cancellation of licence
- Section 22G of the talks act about the pricing committee
- Section 22H of the talks act about the purchase & sale of medicines, medical devices, IVDs & Scheduled substances by wholesalers
- Section 23 of the talks act about the disposal of undesirable medicines, medical devices/IVDs
- Section 24 of the talks act about the appeal against decision of the director general
- Section 24A of the talks act about the appeal against decision of authority
- Section 25 of the talks act about the privileges of authority and committees
- Section 26 of the talks act about the inspectors.
- Section 29 of the talks act about the offences
- Section 30 of the talks act about the penalties
Who all can apply for Medical Device Registration in South Africa?
According to Section 22C(1)(b) of the Act, the Authority may grant a licence to a manufacturer, wholesaler, or distributor of a medicine or medical device to
- Manufacture, import, or export; or
- Import, distribute, or export.
Note: No maker, importer, or exporter may import or export any medical device or IVD unless the South African Health Products Regulatory Authority has granted the individual a licence in accordance with Section 22C(1)(b) of the Act.
Documents Required for Medical Device Registration in South Africa
Following is the list of documents required for Medical Device Registration in South Africa:
- An application form as per the prescribed format
- Labels, IFUs, Package Inserts or promotional materials
- Letter of appointment as an authorised representative of the original manufacturer.
- Copy of the EC Certificate(s) issued by a recognised notified body
- Copy of the EC Declaration of Conformity issued by the original manufacturer
- Technical documentation
Process for Medical Device Registration in South Africa
Following is the process of medical device registration in South Africa:
- Select an authorised representative (AR) for South Africa
(Note: Medical device companies that have applied for a SAHPRA licence are required to nominate an Authorised Representative, who must be a local South African citizen. For all location where the company operate, the company must appoint one representative on all those locations. The representative is in charge of upholding the rules, laws, and regulations.)
- Show that the medical device adheres to all the essential principles.
- To demonstrate conformity, submit an application for the CA certificate to a Conformity Assessment Body (CAB) or an International Notified Body.
- If your application is approved and you have received your CA certificate, then RA will prepare your DoC (Declaration of Conformity)
- AR then submits the application to the Medicines Control Council (MCC)
- A medical device will be registered with the Medical Device Registry.
Manufacturers and distributors that hold a SAHPRA licence are required to show proof of the company’s ISO 13485 accreditation from a recognised conformity assessment agency.
Additional Guidelines Regarding Medical Device Registration in South Africa
Following are the additional guidelines regarding Medical Device Registration in South Africa:
- All submissions must be made in English language only.
- There is no need for local testing. However, additional permits can be needed for electronic products listed in the Schedule for Listed Electronic Products Regulation R1302 of 1991.
- There is no requirement for an inspection abroad. However, the overseas producers must show that they are in accordance with the MDACS’s conformity assessment requirements.
- Since the Radiation Control Department is now a component of SAHPRA, there will only be one official fee and submission needed for both a SAHPRA licence and radiation control, even though there will be two licences granted.
In addition to discussing medical device registration in South Africa, this article also discussed the classification guidelines for classifying medical devices (Non-IVDs) and IVDs. Today, South Africa’s healthcare system is prepared for the digital age, the nation has the skills and capacity to manufacture medical devices, and it stands out from other African nations thanks to its highly competitive and innovative scene. In light of its efforts to modernise its industry, developing nations can learn from it. In order to ensure that there are medical devices available in South Africa that meet an acceptable level of safety, quality, and performance, the medical device section of SAHPRA oversees the licencing of medical device establishments & the registration of medical devices (including IVDs and non-IVD medical devices).