Z E R T I F I K AT. Rayonex Biomedical GmbH DIN EN ISO 9001 : 2008

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2 Z E R T I F I K AT für das Managementsystem nach DIN EN ISO 9001 : 2008 Der Nachweis der regelwerkskonformen Anwendung wurde erbracht und wird gemäß TÜV NORD CERT-Verfahren bescheinigt für Rayonex Biomedical GmbH Sauerland-Pyramiden Lennestadt Deutschland Geltungsbereich Entwicklung, Herstellung und Vertrieb von biomedizinischen und biogeopathischen Produkten Zertifikat-Registrier-Nr Auditbericht-Nr Gültig von Gültig bis Erstzertifizierung 1999 Zertifizierungsstelle der TÜV NORD CERT GmbH Essen, Diese Zertifizierung wurde gemäß TÜV NORD CERT-Verfahren zur Auditierung und Zertifizierung durchgeführt und wird regelmäßig überwacht. TÜV NORD CERT GmbH. Langemarckstraße Essen

3 CERTIFICATE Management system as per DIN EN ISO 9001 : 2008 In accordance with TÜV NORD CERT procedures, it is hereby certified that Rayonex Biomedical GmbH Sauerland-Pyramiden Lennestadt Germany applies a management system in line with the above standard for the following scope Design, manufacturing and distribution of biomedical and biogeopathological products Certificate Registration No Audit Report No Valid from Valid until Initial certification 1999 Certification Body at TÜV NORD CERT GmbH Essen, This certification was conducted in accordance with the TÜV NORD CERT auditing and certification procedures and is subject to regular surveillance audits. TÜV NORD CERT GmbH. Langemarckstraße Essen

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7 Printed with FinePrint trial version - purchase at C E R T I F I C A T E Management system as per Good Distribution Practice for Medical Devices (GDPMD) Medical Device Act 2012 (Act 737) of Malaysia In accordance with TÜV NORD CERT procedures, it is hereby certified that CARESENTRAL (M) SDN BHD ( A) No. 2, Jalan Equine 1E, Taman Equine Boulevard, Seri Kembangan, Selangor D.E., Malaysia. applies a management system in line with the above standard for the following scope Local Authorized Representative, Importation, Storage, Handling & Distribution of Biomedical Devices & Its Related Accessories Products do not require special storage and handling conditions Outsource Activity : Nill This GDPMD Certification is provisional subject to the condition that the Medical Devices is registered. Certificate Registration No Valid until Initial Certification TUV NORD (M) SDN BHD MDA Registration No: MDA/CAB No. 20, Jalan Tiara 3, Tiara Square, Taman Perindustrian UEP, Ir. Bill Kong Subang Jaya, Certification Body Malaysia. at TUV NORD (M) SDN BHD This certification was conducted in accordance with the TUV NORD (M) SDN BHD auditing and certification procedures and is subject to regular surveillance audits.

8 Printed with FinePrint trial version - purchase at A N N E X to Certificate Registration No Good Distribution Practice for Medical Devices (GDPMD) Medical Device Act 2012 (Act 737) of Malaysia CARESENTRAL (M) SDN BHD ( A) No2, Jalan Equine 1E, Taman Equine Boulevard, Seri Kembangan, Selangor D.E., Malaysia. List of Devices Dealt With By the Establishment No Name of medical device Manufacturer Brand/Model Manufacturer product number/code Grouping Class GMDN code Medical device registration number* 1 Biofeedback systems, Magnetic systems, Therapeutic Rayonex Biomedical GmbH Rayocomp PS1000 Polar 3000 System B - * 2 Biofeedback systems, Magnetic systems, Therapeutic Rayonex Biomedical GmbH Rayocomp PS system B - * 3 Biofeedback systems, Magnetic systems, Therapeutic Rayonex Biomedical GmbH Thyreogym 5000 system B - * Note : (*) Medical device is pending for registration End of the list Ir. Bill Kong Certification Body at TUV NORD (M) SDN BHD Valid until Initial Certification TUV NORD (M) SDN BHD No. 20, Jalan Tiara 3, Tiara Square, Taman Perindustrian UEP, Subang Jaya, Malaysia This certification was conducted in accordance with the TUV NORD (M) SDN BHD auditing and certification procedures and is subject to regular surveillance audits.

9 DEPARTMENT OF HEALTH Directorate: Radiation Control Private Bag X62 BELLVILLE 7535 Tel: (021) Fax: (021) Web: BIOMAGNETIC HEALTH SA PTY (LTD) 219 Upper Buitenkant street Cape Town 8001 Enquiries: X-Ray devices: Ms N.P. de Koker Other devices: Mr J.F. Uys Mr S. G. Diedericks Reference 1402/23837 Date: 01 September 2015 Attention: Mr Christoph Lenz - This document contains the licences for electromedical devices as well as the licence conditions that are currently valid. - Apart from the other licensing considerations, the licence for each individual model is issued on the strength of the fact that the intended purpose, as stated in the application form, is considered to be in agreement with the intended purpose of the device as reflected in the manufacturer's labelling and instructions for use (i.e. documentation required in terms of the certification process according to EC Directive 93/42/EEC or 90/385/EEC, whichever is applicable). - The licence for each model remains valid only while the EC compliance documentation is valid. - The safety and performance of all the licensed models remain the responsibility of the licence holder. - Inspections may be performed to ascertain whether the licence conditions are being adhered to. Yours faithfully fordirector-general: HEALTH

10 DEPARTMENT OF HEALTH DIRECTORATE: RADIATION CONTROL LICENCE HOLDER: BIOMAGNETIC HEALTH SA PTY (LTD) ADDRESS: 219 Upper Buitenkant street, Cape Town, 8001 LIST OF LICENCES TO IMPORT NEW ELECTROMEDICAL DEVICES HAZARDOUS SUBSTANCES ACT (ACT 15 OF 1973) LICENCE NUMBER BRAND MODEL LICENCE CONDITIONS 1402/ / /23849 RAYONEX RAYONEX RAYONEX THYREOGYM RAYOCOMP PS 10 RAYOCOMP PS1000 POLAR 01, 09 01, 09 01, 09 Signed at Bellville on 01 September 2015 for DIRECTOR-GENERAL: HEALTH

11 LICENCE CONDITION 01 a) The licence holder must keep a record of every transaction of this model, and such record must include the following information: (i) Name and address of the purchaser. (ii) Brand, model and serial number. (iii) Date of transaction. b) Any advertisement or other kind of promotional material may only contain the information about the intended purpose of this particular model that was supplied in the application form initially. c) If the Department of Health is associated with this model in any advertisement or in other way, the following disclaimer must be clearly displayed, along with the licence number issued to this particular model: "This device has been licensed by the Department of Health. The device therefore complies with the Department's minimum safety requirements, but its clinical efficacy has not been evaluated." d) If this model is used in a medical application, the fact that it has been licensed by the Department of Health may not be used in any way by the licence holder as the basis for any claim regarding the clinical efficacy of this model. e) This model may not be promoted or represented in any way as having been approved by the Department of Health. f) If it comes to the notice of the licence holder or if the licence holder has reason to suspect that units of this model has a defect or a fault, the licence holder must immediately notify the Directorate: Radiation Control of the relevant facts. This written notification must contain the following information: (i) Licence No, Brand and Model (as on licence) (ii) Date on which and circumstances under which such defect or fault was discovered or first suspected (iii) Description of the defect or fault (iv) Evaluation of the risk of injury resulting from such defect or fault (v) Number of units of this model that have been distributed in South Africa (vi) Proposed plan for rectifying such defect or fault - for approval by the Directorate: Radiation Control (vii) Date when execution of such plan is expected to be completed (viii) Proposed instructions regarding the use of this model pending the rectification the defect or fault - for approval by the Directorate: Radiation Control g) This licence is also subject to the provisions of the Regulations relating to Group III Hazardous Substances (Regulation R690, 14 April 1989). Signed at Bellville on 01 September 2015 for DIRECTOR-GENERAL: HEALTH

12 LICENCE CONDITION 09 ANNUAL SUBMISSION OF COMPLIANCE INFORMATION The licence holder must submit the following information by 1 April 2016 with respect to this model, using form 41BM-2: (i) Classification according to Annex IX of EC Directive 93/42/EEC (ii) Annex(es) employed for conformity assessment (iii) EC Certificate No(s) (iv) Date(s) of EC Certificate(s) (v) Expiry Date(s) of EC Certificate(s) (vi) Notified Body Identification No (vii) Date of EC Declaration of Conformity by the manufacturer Signed at Bellville on 01 September 2015 for DIRECTOR-GENERAL: HEALTH

13 Australian Register of Therapeutic Goods Certificate Issued to Caresentral Australia Pty Ltd for approval to supply Caresentral Australia Pty Ltd - Biofeedback system ARTG Identifier ARTG Start date 20/06/2014 Product Category Medical Device Included Class 1 GMDN GMDN Term Intended Purpose Biofeedback system The device is used for improvement of various health conditions including allergy, asthma, eczema, migraine, Angina, Infection control,detox, heavy metal toxity, Vitalisation. Manufacturer Details Address Certificate number(s) Rayonex Biomedical GmbH Sauerland-Pyramiden 1, Lennestadt, Germany ARTG Standard Conditions The above Medical Device Included Class 1 has been entered on the Register subject to the following conditions: The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41FN of the Therapeutic Goods Act 1989., The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the Register are as set out in the following paragraphs., For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be identified., Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III medical device, or Class IIb medical device that is an implantable medical device, the distribution records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall be retained for a minimum period of 5 years., The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation 5.8., It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class IIb provides three consecutive annual reports to the Head of the Office of Product Review, Therapeutic Goods Administration following inclusion of the device in the ARTG (as specified in 5.8 of the regulations). Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be for a period of at least six months but no longer than 18 months. Subsequent reports are to be provided on 1 October for a further 2 years. The annual report must include all complaints and adverse events received by the manufacturer relating to problems with the use of the device that have been received by them over the year. For orthopaedic implant prosthesis that have been re-classified from Class IIb to Class III medical devices, annual report information must be submitted if the device meets either of the following criteria: I.The device was subject to a TGA application audit based on revision rate when the device transitioned from Class IIb to Class III; and/or II.No devices were supplied to the Australian marketplace before 30 June As per the standard automatic condition, annual reports should be submitted each year for the first three years of inclusion as a Class III medical device on the ARTG., Where a medical device included in the Register, contains a substance which is included in the Fourth Schedule to the Customs (Prohibited Imports) Regulations or the Eighth Schedule to the Customs (Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the medical device, be in possession of a licence and a permission for importation or exportation of each

14 consignment of the goods as required by those regulations., A sponsor shall ensure that a medical device within their control is stored and transported in accordance with the instructions and information provided by the manufacturer. Products Covered by This Entry 1. Biofeedback system Product Specific Conditions No specific conditions have been recorded against this entry. Therapeutic Goods Administration PO Box 100, Woden ACT 2606 Australia Phone: info@tga.gov.au ARTG Identifier: ARTG Start Date: 20/06/2014

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