South Africa Medical Device Regulation

Regulatory Authority

South African Health Products Regulatory Authority (SAHPRA) The South African Health Products Regulatory Authority (SAHPRA) is an entity of the National Department of Health, created by the South African government to ensure that the health and well-being of human and animal health are at its core. SAHPRA is a Schedule 3A public entity that is responsible for:

the regulation of health products intended for human and animal use;
the licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices and radioactive nuclides;
the conduct of clinical trials in a manner that is compatible with the national medicine policy.

The Medical Devices Unit of SAHPRA regulates the licensing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality, and performance.

Link for Regulatory Authority

https://www.sahpra.org.za/medical-devices/#:~:text=The%20medical%20device%20unit%20of,level%20of%20safety%2C%20quality%20and

Legislation

Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)

Local Regulation

Regulations relating to Medical Devices and IVDs, published in the Government Gazette No. 40480, on the 09 December 2016.

Classification of Medical Devices

Class A, B, C and D

Registration Of South Africa Medical Device Registration

The registration process for medical devices is still in development. A Registration Call-Up Plan will be published to inform stakeholders of the phased approach in which medical devices will be called up for registration. This plan will specify the type and class of medical devices that will be prioritized and called up sequentially. SAHPRA will implement reliance pathways in the registration of medical devices based on the verification of registration of medical devices in other recognised jurisdictions including Australia, United States, European Union, Brazil, Canada, Japan and or pre-qualification of IVDs by the World Health Organization. Understanding the SAHPRA registration process for medical devices is essential for manufacturers seeking to enter the South African market and comply with applicable regulatory requirements.Manufacturers should also consider SAHPRA registration fees for medical devices when planning market entry.

Process Flow

Listing or Registration Requirements

Appoint an authorized representative (AR) in South Africa. AR submits application to the Council.
Prepare necessary documentation including Conformity Assessment Body (CAB) and Declaration of Conformity (DoC).
Demonstrate the device meets Essential Principles
Demonstrate conformity by applying to a Conformity Assessment Body (CAB) or International Notified Body for the CA certificate.
If the application is successful and CA certificate is granted the RA will now prepare Declaration of Conformity (DoC).

Documents Required

Completed application form 41BM-1(IMP)
Color brochure (including technical specifications); and
Letter of appointment as authorized representative of the original manufacturer; and
Copy of the EC Certificate(s) issued by a recognized Notified Body to the original manufacturer in terms of EC Directive 93/42/EEC or 90/385/EEC (whichever one is applicable); and
Copy of the EC Declaration of Conformity issued by the original manufacturer in terms of EC Directive 93/42/EEC or 90/385/EEC (whichever one is applicable).

Registration Timeline

SAHPRA License:

Regular pathway based on the actual experience: 6-8 weeks
Radiation Control License: 30 days
Official published timeline for expedited regulatory pathway during COVID-19 pandemic: 10-15 working days.

License Validity

5 YearsPlan your SAHPRA medical device licence renewal South Africa before the five-year validity period expires.

Special Requirements

All documents should be submitted in English

Complaints Relating to Medicine and Medical Devices

https://www.sahpra.org.za/complaints-relating-to-medicine-and-medical-devices/
Manufacturers should follow the applicable SAHPRA vigilance reporting for medical devices when reporting adverse events or safety concerns.

Who should make this Communication?

Manufacturer
Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

Act as your Authorized representative
Hire a SAHPRA representative to support regulatory requirements and market entry in South Africa.
Manufacturers can work with a SAHPRA registration consultant medical device to meet regulatory requirements and enter the South African market.

Why Choose Us?

Working towards client satisfaction
Cost effective solutions
Project completion before deadline
Quality Regulatory affairs solutions

Search Article

Ready to Get Started?

Ensuring your medical products meet standards, navigate regulations, and gain market access smoothly

Enquire Now

Frequently Asked Questions

1. What is the South African counterpart to the FDA?

In South Africa the South African Health Products Regulatory Authority (SAHPRA) has responsibility for the regulation of health products, which include medical devices and IVDs.

2. What are the regulatory requirements applicable to medical devices in South Africa?

manufacturer must satisfy the relevant licensing, classification, conformity and documentation requirements if it wishes to place a medical device on the South African market, and in some cases an Authorized Representative will be needed for manufacturers who are based outside of South Africa.

3. What is the regulatory framework applicable to medical devices in South Africa?

Medical devices are governed by the Medicines and Related Substances Act, 1965, together with the Regulations relating to Medical Devices and IVDs, and SAHPRA has the responsibility of keeping these requirements under review.

4. Is it necessary for me to have an Authorized Representative when registering a medical device in South Africa?

If you are a manufacturer who is based outside South Africa, you will probably have to appoint an Authorized Representative in that country, since the representative can assist with the application and with communication with the relevant regulatory authority.

5. What kinds of documents are required in order to register a medical device in South Africa?

The documents will vary according to the relevant registration route and may comprise the application form, the product brochure, the letter appointing the Authorized Representative, the relevant certificates and the Declaration of Conformity.

6. What are the different classes of medical devices in South Africa?

Medical devices are divided into four classes, namely A, B,C, and D; the class that applies is determined by the device and the appropriate classification requirements.

7. What is the time taken to register a medical device with SAHPRA?

The usual time frame is about 6 to 8 weeks according to real experience; however, it can differ depending on the specific application, the documents involved, and the relevant regulatory pathway.

8. What is the procedure for registering a medical device with SAHPRA?

First, identify the requirements that apply to your device and appoint an Authorized Representative if this is necessary. Once you have done this, prepare the required documents, show that you comply with the Essential Principles and then carry out the relevant SAHPRA submission process.