Rayonex Biomedical GmbH

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Transcript of Rayonex Biomedical GmbH

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Essen, 2015-02-27Zertifizierungsstelle

der TÜV NORD CERT GmbH

Diese Zertifizierung wurde gemäß TÜV NORD CERT-Verfahren zur Auditierung und Zertifizierung durchgeführt und wird

regelmäßig überwacht.

TÜV NORD CERT GmbH 45141 EssenLangemarckstraße 20 www.tuev-nord-cert.de

Geltungsbereich

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

Z E R T I F I K AT

Zertifikat-Registrier-Nr. 08 100 012275

Auditbericht-Nr. 3515 2177

Erstzertifizierung 1999

Gültig bis 2018-02-28

Gültig von 2015-03-01

Entwicklung, Herstellung und Vertrieb von biomedizinischen undbiogeopathischen Produkten

Rayonex Biomedical GmbHSauerland-Pyramiden 157368 LennestadtDeutschland

.

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Essen, 2015-02-27Certification Body

at TÜV NORD CERT GmbH

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 45141 EssenLangemarckstraße 20 www.tuev-nord-cert.com

applies a management system in line with the above standard for the following scope

Management system as per

DIN EN ISO 9001 : 2008

In accordance with TÜV NORD CERT procedures, it is hereby certified that

C E R T I F I C A T E

Certificate Registration No. 08 100 012275

Audit Report No. 3515 2177

Initial certification 1999

Valid from 2015-03-01

Valid until 2018-02-28

Rayonex Biomedical GmbHSauerland-Pyramiden 157368 LennestadtGermany

Design, manufacturing and distribution of biomedical and biogeopathological products

.

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C E R T I F I C A T E

Management system as per

In accordance with TÜV NORD CERT procedures, it is hereby certified that

applies a management system in line with the above standard for the following scope

Certificate Registration No. 222 15063 Valid until 2018-07-20

Initial Certification 2015-07-21

TUV NORD (M) SDN BHD MDA Registration No: MDA/CAB - 008 No. 20, Jalan Tiara 3, Tiara Square, Taman Perindustrian UEP, Ir. Bill Kong 47600 Subang Jaya, Certification Body Malaysia. at TUV NORD (M) SDN BHD 2015-07-21 This certification was conducted in accordance with the TUV NORD (M) SDN BHD auditing and certification procedures and is subject to regular surveillance audits.

CARESENTRAL (M) SDN BHD (781406-A) No. 2, Jalan Equine 1E, Taman Equine Boulevard, 43300 Seri Kembangan, Selangor D.E., Malaysia.

Good Distribution Practice for Medical Devices (GDPMD) Medical Device Act 2012 (Act 737) of Malaysia

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.

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A N N E X to Certificate Registration No. 222 15063

Good Distribution Practice for Medical Devices (GDPMD)

Medical Device Act 2012 (Act 737) of Malaysia

CARESENTRAL (M) SDN BHD (781406-A) No2, Jalan Equine 1E, Taman Equine Boulevard, 43300 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

PS10 2284 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 Valid until 2018-07-20

Initial Certification 2015-07-21

TUV NORD (M) SDN BHD No. 20, Jalan Tiara 3, Tiara Square, Ir. Bill Kong Taman Perindustrian UEP, Certification Body 47600 Subang Jaya, at TUV NORD (M) SDN BHD Malaysia. 2015-07-21 This certification was conducted in accordance with the TUV NORD (M) SDN BHD auditing and certification procedures and is subject to regular surveillance audits.

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DEPARTMENT OF HEALTH

Directorate: Radiation ControlPrivate Bag X62BELLVILLE7535

Tel: (021) 9486162Fax: (021) 9461589

Web: https://sites.google.com/site/radiationcontroldoh/

BIOMAGNETIC HEALTH SA PTY (LTD)219 Upper Buitenkant streetCape Town

01 September 2015Date:8001

Enquiries: X-Ray devices: Ms N.P. de KokerOther devices: Mr J.F. Uys

Mr S. G. Diedericks

Reference 1402/23837

Attention: Mr Christoph Lenz

- 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

- 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.

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DEPARTMENT OF HEALTH

DIRECTORATE: RADIATION CONTROL

LICENCE HOLDER: BIOMAGNETIC HEALTH SA PTY (LTD)

ADDRESS: 219 Upper Buitenkant street ,Cape Town, 8001

Signed at Bellville on 01 September 2015

for DIRECTOR-GENERAL: HEALTH

1402/23838

1402/23848

1402/23849

RAYONEX

RAYONEX

RAYONEX

THYREOGYM

RAYOCOMP PS 10

RAYOCOMP PS1000 POLAR

01, 09

01, 09

01, 09

LICENCENUMBER BRAND MODEL

LICENCECONDITIONS

LIST OF LICENCES TO IMPORT NEW ELECTROMEDICAL DEVICESHAZARDOUS SUBSTANCES ACT (ACT 15 OF 1973)

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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

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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:

Signed at Bellville on 01 September 2015

for DIRECTOR-GENERAL: HEALTH

(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

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Australian Register of Therapeutic Goods CertificateIssued to

Caresentral Australia Pty Ltdfor approval to supply

Caresentral Australia Pty Ltd - Biofeedback systemARTG Identifier 224787ARTG Start date 20/06/2014Product Category Medical Device Included Class 1GMDN 10396GMDN Term Biofeedback systemIntended Purpose 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, 57368 Germany

ARTG Standard ConditionsThe above Medical Device Included Class 1 has been entered on the Register subject to the followingconditions:· 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 bythem 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 2012. 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

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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 Entry1. Biofeedback system

Product Specific ConditionsNo specific conditions have been recorded against this entry.

Therapeutic Goods Administration PO Box 100, Woden ACT 2606 Australia Phone: 1800 020 653 Email: [email protected]

ARTG Identifier: 224787 ARTG Start Date: 20/06/2014

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