South African Medical Device and IVD regulations

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Posted 21 December 2016

The medical device and IVD regulations have been published as Government Notice No. 1515 in Government Gazette No. 40480, dated 9 December 2016, and are accessible at http://www.gov.za/sites/www.gov.za/files/40480_gon1515.pdf

(also available on CamCheck as a pdf, and converted to text)

The Sepedi version is at http://www.gov.za/sites/www.gov.za/files/40480_gon1515_pedi.pdf

These are final regulations, for implementation and the ToC is as below:

Medicines and Related Substances Act: Regulations: Medical devices and in vitro diagnostic medical devices (IVD)

LIST OF CONTENTS

  1. Definitions
  2. Manner and conditions for allowing international tendering
  3. Importation of medical devices and IVDs into the Republic
  4. Transmission of medical devices or IVDs through the Republic
  5. Licence to manufacture, import, export, or act as a distributor or wholesaler of medical devices or IVDs
  6. Period of validity of licence issued in terms of regulation 5 and renewal of licences
  7. Appeal against the decision of the Council
  8. Application for registration of a medical device or IVD
  9. Information that must appear in the register for medical devices or IVDs
  10. Amendment to the medical devices and IVDs register
  11. Classifications of medical devices and IVDs
  12. Registration certificate
  13. Parts and components
  14. Destruction of medical device and IVD
  15. Method of taking samples during investigation, certificate to be issued and reporting of analysis results
  16. Conduct of clinical trials and clinical investigations
  17. Adverse event reporting &vigilance
  18. Investigation
  19. Offences and penalties
  20. Compliance with requirements
  21. Advertising of medical device or IVD
  22. Labelling of medical device or IVD
  23. Instructions for Use of medical device
  24. Instructions for Use of IVD
  25. Custom made medical devices
  26. Record of implantable medical devices and custom made medical devices 27. Transitional arrangements – unlicensed manufacturer, distributor and wholesaler 28. Transitional arrangements – unregistered medical devices and IVDs 29. Short title

Regulation 28 is key:

  1. Transitional arrangements regarding unregistered medical devices and IVDs

(1) An unregistered medical device or IVD sold in the Republic at the time of the commencement of these Regulations is, subject to regulation 8, considered to be sold legally until such time as the call -up notice period referred to in sub -regulation (2),for the medical device or 1VD, has expired.

(2) The Council must, from time to time, issue a notice in the Gazette calling for the registration of medical devices and IVDs which notice must-

(a) stipulate which classes of medical devices and IVDs must be registered; and

(b) provide for the conditions and time periods for the application for registration.

(3) Despite sub -regulation (1), the Council may require a medical device or IVD to comply with the requirements that the Council may determine in order to ensure that the medical device or IVD meets the Essential Principles of safety and performance, determined by the Council.

Definitions of Medical Device for regulations of some countries

South Africa Definition:

“medical device” means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent –

(a) used or purporting to be suitable for use or manufactured or sold for use in:

(i) the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or

(ii) restoring, correcting or modifying any somatic or psychic or organic function; or

(iii) the diagnosis or prevention of pregnancy,

and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or

(b) declared by the Minister by notice in the Gazette to be a medical device,

and includes any part or an accessory of a medical device.

 

European Union Definition:

(a) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(ii) investigation, replacement or modification of the anatomy or of a physiological process,

(iii) control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

(b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device

 

Australian Definition:

A medical device is defined in the Therapeutic Goods Act as “any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the

software necessary for its proper application) intended, by the person under whose name it is

or is to be supplied, to be used for human beings for one or more of the following:

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

(iii) investigation, replacement or modification of the anatomy or of a physiological process;

(iv) control of conception”

A device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means; or an accessory to such an instrument, apparatus, appliance, material or other article.

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