All fibre laser machine owners have to register with the authority and obtain a license.
The benefits of fibre laser processing in manufacturing have been widely demonstrated over past decades and recently, fibre laser welding has received increased interest. Now more than ever, the concept and practice of laser safety is a moving target. More metal processing companies are embracing laser technology to produce or repair all sorts of parts, which means employers must protect laser operators and workers by ensuring they receive up-to-date training and the right protective equipment. They must also adhere to the regulatory requirement in licensing their unit(s) for use.
The South African Health Products Regulating Authority (SAHPRA) would like to inform importers of fibre laser machines that they have to register (license) their fibre laser machine models with SAHPRA and ensure that their clients also licence their units for use. This includes all machines that are already operating.
“We administer the Hazardous Substances Act, Act 15 of 1973 and Regulations relating to the importation and use of listed electronic products. This includes inter alia medical and non-medical X-ray, UV, IR and laser units, as well as electromedical devices,” said Johan Uys, a senior scientist at SAHPRA and the person responsible to try to ensure that all machines in South Africa are registered and licensed.
“The reason we require users of laser machines to have it licensed is to try and ensure that products comply with standards for safety and quality.”
“The focus with regards to non-medical lasers is the safe use of Class 3B and Class 4 laser systems.
A licence (per model) is required for importation and for use (per unit).”
“You can obtain a licence application form for importation and for the use, as well as the document specifying the Requirements for the use of any (not just fibre) Class 3B or Class 4 laser system, from SAHPRA.”
“There are about 700 non-medical laser models licensed with about 100 importers. We have about 3 700 licensed Class 3B and Class 4 laser units (medical and non-medical). I can’t say how many are used in the metalworking field but would guess that currently about 90% of the licensed units are used in the medical field.”
“The regulations apply to all Class 3B and Class 4 laser systems so a laser welder falls into this category and will have to be licensed.”
“About 10 of the 20 importers of machines used in the metalworking field have responded. These importers did supply applications from their users but we don’t know how many machines are being used in South Africa.”
Actions to take if you are currently operating an illegal / unregistered laser
“The laser operator is not required to register with any controlling body. If a Class 3B or Class 4 lasers is used, the machines must be registered with SAHPRA (https://sahpra.org.za/).”
“SAHPRA regulates both medical and non-medical lasers.”
“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 or any person that takes responsibility for the safe use of the machine.”
“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 a 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.”
The safe use of Class 3B and Class 4 laser systems
“It is all about the safe use of Class 3B and Class 4 laser systems. Unfortunately, the Act (Hazardous Substances Act) and Regulations require a licence application form for import and use.”
“Depending on the size of the equipment any device, appliance or even a vehicle may be seized (or sealed/disposed of) if there is reasonable ground to believe that an offence or suspected offence is committed. There are fines and/or imprisonments ranging from two years to 10 years. Seizure of devices may be done in collaboration with the SAPS.”
“The device may be sealed, as indicated above, with penalties according to the Act if a seal is broken. It may be released if it no longer contravenes the requirements, and any costs will be recovered from the “owner of the object” seized under specific sections of the Act.”
“If the correct information is submitted we usually issue a licence within a week or even less depending on the work load. The licence stays valid for an “indefinite” period (depending on the type of product). A licence can be cancelled if it is found at a later that untrue or misleading information was supplied, or the licensee no longer complies with the licensing conditions.”
“There is currently no fee for a license but it is specified in the Act that a licence fee may be required. 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.”
“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 objective of these requirements is to provide reasonable and adequate guidance for the safe use of laser systems. A practical means for accomplishing this is to use the classification of laser systems (according to their relative hazards) to specify appropriate controls.”
“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.”
The contact person for registration of laser devices at SAHPRA is Johan Uys and can be contacted at email@example.com.