Atlas Copco has applied for licencing of its turnkey BeaconMedæs ISO 7396-1 accredited medical gas solutions portfolio to the South Africa Health Products Regulatory Authority (SAHPRA) in line with recent amendments to regulations relating to medical devices and in vitro diagnostics (IVDs).
In August 2016, the Registrar of the MCC issued guidelines for a licence to manufacture, import, export or distribute medical devices, initiating the first practical step towards medical device* registration in South Africa. The publishing of ‘Regulations relating to medical devices and in vitro diagnostic medical devices (IVDs)’ by the Minister of Health in the Government Gazette on 9th December 2016 mandates all companies involved in import, export, wholesale, manufacture or distribution of Class B, Class C and Class D medical devices and IVDs to apply for licencing from the regulating authority in order to continue trading legally in South Africa. In accordance with the licencing requirements, an authorised representative must be designated in the application together with providing particulars of the prospective holder of the certificate of registration. Any person residing and doing business in South Africa can make the application for registration.
Atlas Copco mVAC systems provide highly reliable medical vacuum
Charl Ackerman was recently appointed Business Line Manager of Atlas Copco Compressors Technique’s Medical Gas Solutions division and is spearheading the company’s licensing initiative. As Business Line Manager for Compressor Technique’s Industrial Air division for six years, Ackerman brings a wealth of air technology experience to the medical portfolio.
“Quality has always defined Atlas Copco products, whether in the industrial, mining or medical space. We extend our quality beyond product to our innovations, our engineering expertise, our state-of-the art designs and our service acumen,” notes Ackerman. “As thought leaders and pioneers of numerous developments, we also accept the necessary responsibility and accountability. So applying for a licence for our BeaconMedæs medical gas solutions offering in South Africa was simply the right thing to do. We encourage all companies to follow our example and apply for registration.”
Atlas Copco purchased Beacon Holdings Corp, parent company of BeaconMedæs and Medaes Ltd., in 2006, positioning BeaconMedæs as the global competence centre for medical solutions within Atlas Copco. With deep roots in the entire medical gas industry, BeaconMedæs is a market leader in innovative medical gas and laboratory systems and services. Additional product development expertise, powerful global brand recognition and the extensive international sales and service distribution network of Atlas Copco has further boosted BeaconMedæs’ global growth.
Atlas Copco OGP5 Oxygen Generator
Ultra clean air plays a critical role in patient care; delivered to theatres and hospital beds, the medical air supply at health care facilities is a vital life support service. Medical air is classified as a drug and the concentration of impurities must be carefully controlled to ensure compliance with the European pharmacopoeia monograph. As part of the Atlas Copco Group, BeaconMedæs’ range of medical gas products and systems are in accordance with HTM 02-01, ISO 7396-1 and European Pharmacopoeia standards and includes medical air systems (oxygen generators, air compressors, air filters, dryers, etc.), medical vacuum systems, anaesthetic gas scavenging systems (AGSS), manifold control systems (all gases), monitoring and alarm equipment (all gases) and pipeline components (all gases). “Our medical gas portfolio also extends to air supply for pneumatic surgical tools and pneumatic ceiling pendants,” adds Ackerman.
“Packed with features, the BeaconMedæs medical air products and systems offer unparalleled performance, reliability, efficiency and safety for increased life cycle and reduced operating costs, delivering lowest overall total cost of ownership and peace of mind,” concludes Ackerman.
Pre certified ISO 7396_1 Atlas Copco GA MED screw compressor range
* ‘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.