Medical and aesthetical laser regulations for South Africa.
Legal requirements to operate a laser:
- The laser therapist / operator is not required to register with any controlling body.
- If a class 3 or class 4 lasers is used, the machines must be registered with the South African Health Products Regulating Authority (SAHPRA, https://sahpra.org.za/).
- A Laser Safety Officer (LSO) must be registered for each machine. One person can be the LSO for various machines. The LSO can either be the owner or an employee.
- To be able to register the machine with SAHPRA as mentioned above, the machine must have a valid import licence from SAHPRA. It is of utmost importance to confirm with SAHPRA that the machine you are about to buy has an import licence, since you cannot register as an user without this licence number. If you want to import your own machine, see ‘requirements to import and sell’ for steps to obtain this licence.
- IPL’s and LED-devices are excluded from this regulation and do not require any licensing for use. These devices can be purchased and operated freely by anyone.
- The contact person for registration of laser devices at SAHPRA is Johan Uys and can be contacted at johan.uys@sahpra.org.za or 021 015 5510.
Actions to take if you are currently operating an illegal / unregistered laser:
- Unlicensed lasers in operation can be confiscated at any point in time. It is therefore of utmost importance to register your equipment to protect your investment.
- Take contact up with Johan Uys at SAHPRA at johan.uys@sahpra.org.za or 021 015 5510.
Legal requirements to import and sell lasers, IPL’s and LED-devices:
- A separate licence must be obtained for each model of device. If a distributor sells three different models from the same manufacturer, (s)he requires three separate SAHPRA licences.
- No licence is needed for the USE of IPL’s and LED-devices but an import licence is still required.
- Any person of legal age can apply for a licence from SAHPRA to import and sell lasers.
- The following documentation is need when applying for a licence.
- Completed application form 41BM-1(IMP); and
- Colour brochure (including technical specifications); and
- Letter of appointment as the sole authorised agent/representative of the original manufacturer in South Africa; and
- EC Certificate(s) issued by a Notified Body in terms of EC Directive 93/42/EEC; and
- EC Declaration of Conformity by the manufacturer in terms of EC Directive 93/42/EEC.
- The contact person for licensing lasers for import at SAHPRA is Johan Uys and can be contacted at Johan.uys@sahpra.org.za or 021 015 5510.
