AAMSSA Report: The new medical device regulations act… what you as a patient/consumer need to know

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AAMSSA President Dr Cobus van Niekerk sheds some light on the long-awaited regulations act for medical devices (MD) and in vitro devices (IVD’s), and discusses how this will affect the industry. 

Dr Aaron Motsoaledi – in consultation with the Medical Control Council (MCC), published regulations in the National Gazette on the 9thof December 2016.

The act was initially supposed to take effect on the 1st of June 2017, however, an extension of one year has been given before the act comes into effect, which may take even longer than the year mentioned.

What does this mean? 

There are certain rules and regulations that apply to manufacturers, importers, exporters, distributors or wholesalers of medical devices (MD’s) and In Vitro Devices (IVD’s) that needs to be adhered to, but that goes beyond the scope of this piece.

There are several pieces of information necessary to register an MD or IVD (e.g. Name, Make and Model of MD or IVD, the Registration Number, Name and Address of License holder, etc).

* The following are the classes of medical devices and IVDs:

(a) Class A: Low Risk;

(b) Class B: Low-moderate Risk;

(c) Class C: Moderate-high Risk;

(d) Class D: High Risk, (Inclusive of all injectables) where risk relates to the patient, user or to public health.

Therefore, the public should be aware that devices cannot be mentioned or advertised by trade name (so, Botox®, Dysport®, Restylane®, Juvéderm®, Radiesse, Ellanse, Princess, Silhouette Soft Threads, PDO Threads, Teosyal, Thermage®, Skinboosters®, Hyalual XelaRederm® etc. will not be allowed).

What can you advertise?

Generic terms like anti-wrinkle injection (botulinum toxin), hyaluronic acid based fillers, dermal fillers, laser hair removal, micro-needling etc. will be allowed, but no registered trade names.

In addition, it must be noted that it’s already an offense to advertise BOTOX® or DYSPORT® – even in the current legislation, as they are Schedule 4 Medications, as well as under the new act, which means they will also be classified as class D devices.

Moreover, adverse events must be reported to the MCC within the time-frame set out by the Council, with possible concise critical analysis to deem whether or not a MD or IVD is still safe to use.

Offences and penalties

If an individual fails to comply to the rules of this act – or sells a MD or IVD that has expired – they are guilty of an offence and hence, upon conviction, is liable to a fine or imprisonment for a period not exceeding 10 years.

Advertising and marketing

* The following requirements apply to an advertisement of a medical device or IVD:

(a) Only Class A and Class B medical devices and IVDs may be advertised to the public or a lay person.

(b) Despite sub-regulation (a), male or female condoms may be advertised to the public.

(c) An advertisement for a medical device or IVD may not contain a statement which deviates from, or is in conflict with, or goes beyond, the evidence submitted in the application for registration of the medical device or IVD, with regard to its safety, quality, or performance where the evidence has been-

  • (i) accepted by the Council in respect of the medical device or IVD; and
  • (ii) incorporated into the approved instructionsfor use of the medical device or IVD

(d) A written advertisement for a medical device or IVD must contain-

  • (i) the name of the medical deviceor IVD; and
  • (ii) in the case of a registeredmedical device or IVD,the registration number allocated to the medical device or IVD;

(e)

  • (i) when a Class C or Class D medical device or IVD is advertised for the first time to a prospective user (not the lay public), written information,which must include the informationreferred to in regulation 23 or regulation 24 as the case may be, must simultaneously be given to theperson to whom the oral, electronic orprinted advertisement is directed; and
  • (ii) when the medical device or IVD is advertised on subsequent occasions, the information must be available on request.

Additional key rules/regulations

  1. No special offers are allowed to be made in terms of the act, and several companies have already complied by reducing the price of a single unit and not allowing discounts.
  2. A permanent record in respect of Class D implantable devices has to be kept for 50 years after selling a device.
  3. Until the Council issues a notice in the Government Gazette calling for the licensing of unlicensed manufacturers, distributors or wholesalers, anyone selling MD’s or IVD’s will be considered to be subject to regulation 5 of the act, and therefore considered to be trading legally.

Take home message

So, in summary, to advertise botulinum toxin type A, any fillers, or any other class C or D device by its trade name, will be seen as contravention of this act, and be liable to conviction and sentencing as set out above.

It is not only the doctor, but also the patient’s duty to participate actively in their treatments, understand the risks, ask for expiry date, and to report any adverse events to their doctor, so that this can be followed up by the pharmacological companies. Patient should also be educated that they are allowed to phone their doctors to ask about pricing or promotions, but that such advertising in the recent future will be against the act.

For more info, please consult the Aesthetic and Anti-Ageing Medicine Society of South Africa’s website www.aestheticdoctors.co.za. You can also find further information regarding procedures, as well as well-trained doctors and their contact details in your area.

Being educated brings power to you as the patient.

For any enquiries, please reach out on info@aestheticdoctors.co.za, www.aestheticdoctors.co.za or cobus@drcobus.co.za

A2 Disclaimer: This article is published for information purposes only, and should therefore not be taken as an endorsement –  nor should it be regarded as a replacement for sound medical advice. 

CURRENT Issue 26 – June 2018 (Winter)

This article was written by Dr Cobus van Niekerk and edited by the A2 team EXCLUSIVELY for the A2 Aesthetic & Anti-Ageing Magazine June 2018 Edition (Issue 26). 

A2 Magazine prints only four magazines each year – reporting seasonally on everything you need and want to know about aesthetics, anti-ageing, integrative medicine, quality and medical skin care, cosmetic dentistry and cosmetic surgery in South Africa – where to go, who to see, what to expect, something new and so much more! Never miss an edition – click here for more info about where you can buy the print and/or digital copy of A2 Magazine (including back copies).

To make use of any of our content for re-publishing, you must contact info@a2magazine.co.za for approval.

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About Author

Dr Cobus van Niekerk

Dr Cobus van Niekerk, MBChB (Pret), BMedScHons (Stell), MRCS A&E (Edinburgh). Dr Cobus van Niekerk graduated from the University of Pretoria in 1997 and received his BSCMedScHons (cum laude) from the University of Stellenbosch in 2001. He became a member of the Royal College of Surgeons of Edinburgh in 2007 but decided to return to South Africa after six years abroad. Dr Cobus is also a SAMA national councilor and serves on the Human Rights Law and Ethics (HRLE) and GP Private Practice Committee (GPPPC). He is president of AAMSSA (the Aesthetic & Anti-Ageing Medicine Society of South Africa).

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