7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002. 1 and amended Regulation 5. The TGA may request that the manufacturer provide the raw material and finished product specifications at any time. • each country measures their performance in a different way. Part 6A - Procedures applying only to certain classes of in-house IVDs. The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device: (a) to: (i) implement a quality management system for the design, production, packaging, labelling and final inspection of MANUFACTURER’S DECLARATION OF CONFORMITY. (note; some information is outdated, please see current requirement factsheets for up to date information) The essential principles checklist. Sponsors have always been required to hold a DOC on file, but this will now be required to be submitted as part of the application. au https://www. The manufacturer may hold a Declaration of Conformity made under legislative provisions of other jurisdictions, however, the TGA requires a copy of the Declaration of Conformity that satisfies For the possible abridgement of an assessment of a TGA conformity assessment application, you may provide certain documents from specified overseas assessment bodies to facilitate the TGA’s overall conformity assessment evaluation process. For Class 1 IVDs the evidence (Declaration of Conformity) is not required to be submitted to the TGA but MUST be available upon request. This form, when completed, will be classified as 'For official use only'. Issue of certificates. For more information refer to: • Therapeutic Goods Act 1989 • Therapeutic Goods (Medical Devices) Regulations 2002 • Therapeutic Goods Regulations 1990 TGA or an acceptable conformity assessment body Australian Declaration of Conformity (DoC) • Once the manufacturer has obtained conformity assessment evidence, they must make a DoC to Australian requirements • The DoC declares that the device complies with: - the applicable provisions of the Essential Principles - the classification rules This is a declaration of conformity made under clause 7. 9(1) Class Is : Declaration of Conformity - Part 6 plus: • CAC** Production Quality Assurance - Part 4 • Annex II. TGA use only. objective following provides industry with an integrated point of entry to TGA Online Services. ). This means that from 28 July 2021, medical devices that contain medicines or materials of animal, microbial, recombinant or human origin; and Class 4 in vitro diagnostic (IVD) medical devices no longer require mandatory TGA conformity assessment Feb 29, 2024 · Forms must be current and complete. The ongoing obligations of a manufacturer vary depending on which conformity assessment procedures they have used. The table below summarises the conformity assessment procedures most likely to be used for each class of IVD based on TGA experience with equivalent classes of medical devices (other than IVDs). Giving false or misleading information as part of a statutory declaration is a criminal offence under the Criminal Code. 3 of the Therapeutic Goods (Medical Devices) Regulations 2002. Document Number: IVD Technical File Declaration of Conformity for V5E Instrument S-RA-TEC-0004. Manufacturer must apply appropriate conformity assessment procedure to the device. On 23 July 2021 the Government repealed Regulation 4. manufacturer applicants an application, applications manufacturer Conformity or an Assessment an e-Business Certification. Approved IVDs supported by ISO 13485 certificates remain valid until the certificate expires. It shows that the device is fit for its intended purpose stated and meets Class 1 and Class 2 IVDs. For Class 2 IVDs Part 4 (Production Quality Assurance) is also required. Conformity Assessment Requirements of the Devices. Conformity assessment certification may no longer be valid due to the certification expiring, or if it has been suspended or revoked. Conformity assessment procedures for each class of IVD; Parts 1 to 8; TGA conformity assessment certificates; Pre-submission meetings; Documentation for applications; Components of the STED or design dossier; Depth of information to be provided Oct 2, 2020 · All ARTG applications of Class I Medical Devices will be required to submit an Australian Declaration of Conformity. What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs. gov. Declaration. TGA Conformity Assessment Certificate. This document is controlled and released electronically in Grand Avenue. Follow our easy steps to have your Declaration Of Conformity Templates (medical Devices) - TGA well prepared rapidly: Glossary - Declaration of Conformity declare that the medicinal cannabis products mentioned in section 3 conform with the requirements specified in the Therapeutic Goods Order No. . The Declaration of Conformity must be maintained and updated by the manufacturer. After conducting the assessment: MANUFACTURER’S DECLARATION OF CONFORMITY AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 product quality assurance procedures This is a declaration of conformity made under clause 5. e. Declaration of Conformity. 1800 14 11 44. This is a compulsory step of the conformity assessment process. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law. As part of the conformity assessment procedures, the manufacturer of a medical device is required to make a declaration of conformity which declares that the device complies with: tial principlesthe classification rulesan appropriate conformity assessment procedureThe declaration also requires the manufacturer to provide Declaration of Conformity. A working day is any day other than a weekend, a public holiday in the Nov 13, 2023 · conformity assessed by a body that has been designated to undertake conformity assessments by a comparable overseas designating authority; or; approved by a comparable overseas national regulatory authority. 3 OR MANUFACTURER’S DECLARATION OF CONFORMITY AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 full quality assurance procedures This is a declaration of conformity made under clause 1. This will result in the TGA being able to reduce the amount of assessment that The manufacturer may hold a declaration of conformity made under the legislative provisions of other jurisdictions, however the TGA requires a copy of a declaration of conformity that satisfies the Australian legislative requirements. Declaration of conformity templates (medical devices) Medical devices information unit. Example: DIRECTIVE 2014/28/EU - explosives for civil uses. The TGA will assess applications for compliance with the legal requirements for Class I medical devices to be included in the ARTG. After conducting the assessment: Appeals against licensing/conformity assessment certification decisions made by the TGA can be made in accordance with Section 60 of the Act. Generally, the conformity assessment procedure is more rigorous the higher the risk class. The sponsor is allowed to sign the Declaration of Conformity only if it is the manufacturer as well. Supporting documentation for inclusion of a medical device. 5 of Schedule 3 of the Regulations for a system or procedure pack. N/A : Regulation 3. Manufacturer's name: ®ImpediMed Limited Manufacturers are required to comply with conditions imposed automatically on the TGA issued conformity assessment certificate under the Act that they notify the TGA in writing of any plan for substantial changes to the following matters: Quality Management System (QMS) the product range covered by those systems. Use either the Word or PDF version of the form with additional form pages as needed (e. on behalf of the. Copy/paste in the left column the number of the article and in the right column the text which contains “declaration of conformity”. On this page you will find compliance certificates for TGA, TUV, CE and Australian Standards. Updated EC Certificate. The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device: (a) to: (i) implement a quality management system for the design, production, packaging, labelling and final inspection of Email: clinical. Once this application has been accepted by the TGA, the sponsor can use the manufacturer's evidence to apply for the system or Manufacturers of Class 1 IVDs must still apply the appropriate conformity assessment procedure and prepare an Australian Declaration of Conformity (DOC), this needs to be submitted to the TGA with the device application. Therapeutic Goods (Medical Devices) Regulations 2002. Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019. TGA eBusiness Services 2 ' ' issues a declaration of conformity and in Europe will apply a CE mark to product and notifies any adverse incidents to TGA Each product or family of products requires a technical file. Read the text carefully. 5 Statutory declaration . The sponsor of the first aid kit is required to vary their manufacturer's evidence, attach the updated declaration of conformity and, once this has been accepted, request the TGA to vary the respective ARTG entry if the information included in the ARTG for the first aid kit (for example, the GMDN code) has changed as a result of the replacement May 20, 2024 · At this time, a subsequent declaration of conformity will be required. The change to the assessment process A European declaration of conformity is not acceptable. 1. The DoC can be in any format, but it must include the following information: The notification form is located on the Therapeutic Goods Administration (TGA) Consultation Hub. The TGA appreciates that the manufacturer may not have an exact date, Product certifications. relating to the <stated devices OR the devices stated in the attached Apr 27, 2022 · As further explained by the HSA, a Declaration of Conformity should be prepared and signed by an authorized person to be appointed by the party responsible for a medical device. trials@health. The declaration is signed in the presence of a witness. PO Box 100 Woden ACT 2606ABN 40 939 406 804. The TGA publishes information on the current fees and charges for therapeutic goods. Phone: 1800 020 653 (freecall within Australia) or +61 2 6289 4124. Copy/paste all other hits to the table. For such devices (those that contain medicines or materials of animal, microbial, recombinant or human origin, and Class 4 IVDs), we will accept conformity assessment evidence issued by the TGA, EU notified bodies and Australian Conformity Assessment Bodies. Manufacturer Evidence Page 3. In deciding whether to issue a Conformity Assessment Certificate under Section 41EC of the Act the Secretary, or delegate, must, under paragraph 41EC(3)(a) of the Act, consider whether an MANUFACTURER’S DECLARATION OF CONFORMITY AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 FULL QUALITY ASSURANCE PROCEDURES This is a declaration of conformity made under clause 1. Acceptance of ME by the TGA is the first step before applying for a medical device to be included in the Australian Register of Therapeutic Goods (ARTG). You are required to identify the type of Manufacturer Evidence you have in relation to your Medical Device. 5 of Schedule 3 of the Regulations by the manufacturer of the system or procedure pack, to make a Manufacturer's Evidence application. Instructions on how to make an appeal are provided in the letter advising the outcome of the licensing/conformity assessment certification decision.  Manufacturer's name: <Person responsible for manufacturing the May 17, 2021 · A Conformity Assessment Certificate issued by the TGA itself, An EC Certificate or other similar document issued by a comparable overseas authority, Declaration of Conformity for a system or procedure pack, A Certificate issued by a recognized Notified Body under the Mutual Recognition Agreement (MRA). managing eBS account user portal. TGA Business Services: getting started with the TGA . The TGA endeavours to meet industry-agreed time frames for assessments for conformity assessment certification. Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. May 25, 2021 · The Declaration of Conformity could be signed only by the medical device manufacturer itself. Presented by: Xin-Lin Goh and Amanda Craig, Therapeutic Goods Administration Presented at: O nline Presentation date: Tuesday, 6 December 2022 Presentation summary: This is the first in a series of three educational webinars outlining what regulatory actions are required as a result of changes under the EU MDR, and what the Therapeutic Goods Administration (TGA) is doing to streamline the Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA; Cyber security for medical devices and IVDs Cybersecurity is an important consideration for medical devices and IVD medical devices (IVDs) D Declaration of conformity templates (medical devices) Forms for manufacturers to make Declarations of Conformity for a medical device; G. For more information refer to: Therapeutic Goods Act 1989. Hard copies are uncontrolled and should not be relied upon for the most recent version unless formally issued and stamped by QA. Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). The Expert Review of Medicines and Medical Devices Regulation (MMDR) made recommendations aimed at streamlining the TGA's processes for including medical devices in the ARTG in If the conformity assessment procedure is completed with a positive outcome, the TGA issues the relevant certificate of conformity. As a guide, documentation that is generally requested includes: List of critical processes and the status of their validation (ISO 13485: PO Box 100 Woden ACT 2606 ABN 40 939 406 804. Jun 13, 2023 · Create a table with two columns in a document or spreadsheet. Post: PO Box 100 Woden ACT 2606 ABN: 40 939 406 804. DEMONSTRATION OF CONFORMITY WITH RECOGNIZED STANDARDS TO SATISFY THE SAFETY AND EFFECTIVENESS REQUIREMENTS OF THE CANADIAN MEDICAL DEVICES REGULATIONS. In summary, the present TGA guidance clarifies the most important aspects related to the Declaration of Conformity – a document to be provided by the Jan 24, 2024 · For general regulatory information, please contact the Division of Industry and Consumer Education (DICE) by phone at: (800) 638-2041 or (301) 796-7100 or by email at: DICE@fda. Our state-specific web-based blanks and crystal-clear instructions remove human-prone mistakes. An overseas manufacturer may choose to engage an Australian agent to lodge the application on their behalf; however this is not a TGA requirement. docx. See Conformity assessment certificates, changes to requirements for certain medical All manufacturers can lodge an application for a Conformity Assessment Certificate directly with the TGA. The applicant will be given an explanation and statement of reasons for any refusal to issue, or restriction on, the TGA Conformity Assessment Certificate. The TGA requested feedback on the new Class I device inclusion process through a survey published on TGA Consultation Hub. Medicinal cannabis products - Declaration of conformity with Therapeutic Goods Order (TGO) 93(July 2018) For official use onlyPage 6 of 6. The Declaration of Conformity provides s ponsors and the TGA with information about a medical device to ensure compliance with the Essential Principles, the classification rules and the appropriate conformity procedures, as provided under Australian legisla tion. Sponsors of existing IVD ARTG entries that need to transition to new manufacturer evidence will need Jul 13, 2021 · Table No. The ongoing obligations of a manufacturer vary depending on • the end of the transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence, unless supported by the manufacturer’s EU Declaration of Conformity made under the IVDD, before 26 May 2022. Phone: 1800 020 653 Fax: 02 6203 1605 Email: info@tga. 5 of Schedule 3 to the . Inspection Nov 28, 2021 · The declaration of conformity provides sponsors and the TGA with information about medical devices to ensure compliance with the Essential Principles, the classification rules, and the appropriate conformity procedures, as provided under Australian legislation. Title of form (Month Year) For official use onlyPage 3 of 3. Now, working with a Declaration Of Conformity Templates (medical Devices) - TGA takes not more than 5 minutes. Medicinal cannabis products - Declaration of conformity with Therapeutic Jul 12, 2024 · The degree of rigour of the TGA's assessment of applications for inclusion of medical devices in the ARTG depends on the intended purpose and risk classification of the device, and the source of the conformity assessment certification. This Declaration of Conformity (DoC) is required under clause 6. Associated fee for a variation for a Class 3 COVID-19 test of the same kind. Step-by-step instructions on how to submit a variation application are available on the TGA website. Jun 19, 2024 · There are also responsibilities where a TGA issued conformity assessment certificate transfers from one entity to another. Name of the medical device as it appears on the label: coDiagnostiX. Class I : Declaration of Conformity - Part 6 . Copy of current conformity assessment evidence for the IVD and the manufacturer: Conformity assessment evidence is the certificate(s) issued by a regulatory body, conformity assessment body or certification body that demonstrates: Step 1 Create an e-Business account. The purpose of this guidance is to provide an overview of how specific overseas assessments and approvals can be used by applicants for: 3 days ago · A TGA Conformity Assessment Certificate; Overseas market authorisation evidence or conformity assessment document relating to the manufacturer's quality management system from a comparable overseas national regulatory authority; Declaration of Conformity to clause 7. Submit evidence Transfers of conformity assessment certificates. The TGA’s slides for the webinar on the Regulatory changes. As regulations in Australia are similar to those included in the EU directives for medical devices, the registration of products already certified in the EU involves only minor costs and efforts. The TGA may also contact you at any time after your device has been included in the ARTG to request documentation demonstrating that your product complies with any aspect of the prior to applying for conformity assessment of the device; whereas in Australia, these occur in parallel as a part of TGA’s conformity assessment for high risk devices. Merits products comply with regulations of the Therapeutic Goods Association of Australia (TGA) and have been certified by strict international standards such as TUV, ISO, FDA (USA), CE (Europe) and JIS (Japan). The manufacturer’s Declaration of Conformity form for Class I non-sterile, non-measuring devices has been revised to be more user-friendly. The decision is also appealable, subject to the Jul 25, 2020 · However, upon request, the sponsor may have a copy of the manufacturer’s declaration of conformity for the device and be able to provide it to the TGA on request together with the other documentation relevant to the device (e. Dec 31, 2020 · A UKCA mark is a logo that is placed on medical devices to show they conform to the requirements in the UK MDR 2002. hhs. The TGA may approve the inclusion of a device in the ARTG based on the information provided in the application First aid kits are regulated by the Therapeutic Goods Administration (TGA) as medical devices that are system or procedure packs, as they contain a combination of two or more goods including at least one medical device, which are all packaged together for convenient use in an emergency and for rapid, initial treatment of injuries. You must also submit an electronic copy of the Evidence. g. The declaration of conformity must be completed by the manufacturer or an authorised The declaration of onformity provides c ponsors and the TGA with information about medical s devices to ensure compliance with theEssential Principles, the classification rules and the appropriate conformity procedures, as provided under Australian legislation. For more information refer to: • Therapeutic Goods Act 1989 • Therapeutic Goods (Medical Devices) Regulations 2002 • Therapeutic Goods Regulations 1990 Jun 14, 2024 · This instrument amends the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 to specify that a declaration of conformity must accompany an application for inclusion in relation to certain Class I medical devices and Class I system or procedure packs. The COVID-19 pandemic post-market review of facemasks is now closed. (Declaration must be made in accordance with Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002) Provided under TG (MD) Regulations . GMP Clearance questionnaire Complete this questionnaire prior to submitting your GMP clearance application and upload it as part of your evidence package on your TGA ebusiness services portal; I. The manufacturer's Declaration of Conformity template for Class I non-sterile, non-measuring devices has been revised to be more user-friendly. Manufacturer’s Declaration of Conformity for Class I non-sterile, non-measuring or Class 1 in vitro diagnostic (IVD) medical devices. The TGA uses statutory declarations whenever certain situations Jun 21, 2024 · For some Class I devices, this requires holding an Australian Declaration of Conformity. Sponsors must obtain a copy of a declaration of conformity, made under clause 7. For manufacturers applying for or holding a TGA conformity assessment certificate that also have MDSAP certification, the TGA performs a desk top review of MDSAP audit reports. 6 (for single devices or kinds of devices) of Schedule 3 of the. Applications can also be lodged on behalf of the manufacturer by another party. Certificates will be issued to the manufacturer once: all fees (assessment, additional audit fees) are paid in full. devices@tga. S-RA-REP-00129 Revision: 1. While you do not need a Conformity Assessment Certificate from the TGA (or a European notified body or other recognised comparable regulator), the manufacturer of a Class I (Export Only) device will need to make a Declaration of Conformity (DoC). Conformity assessment bodies. MANUFACTURER’S DECLARATION OF CONFORMITY. The Australian Declaration of Conformity states which conformity assessment procedures the manufacturer has chosen to use to demonstrate that their medical device meets the Essential Principles. Name of the Manufacturer of the medical device: Dental Wings GmbH. tga. Users who are deaf or have a hearing or speech impairment can call through the National Relay Service: TTY or computer with modem users: phone 1800 555 677 then ask for 1800 020 653. (quality management system and control over the design of the device) Sponsor must lodge the manufacturer’s certification of the conformity assessment with the TGA. Created with S-QMS The TGA no longer accepts ISO 13485 certificates to support applications for new IVD devices, except if the manufacturer made a declaration of conformity under the EU IVDD before 26 May 2022. THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002. A statutory declaration is a written statement allowing a person to declare something to be true. 8 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002. FDA’s S 4- New valid conformity assessment certification: select if the medical device manufacturer is seeking new conformity assessment certification. Share. , for several facilities, devices, etc. f - Template for External Form - Version 3. au. Commonwealth Consolidated Regulations. 5 February 2013. The usual approval process of medical devices by the TGA looks like: As detailed above, once the Conformity Assessment Certificate is received from the TGA, a Declaration of Conformity (DoC) needs to be prepared by the manufacturer declaring that the medical device complies with the applicable essential principles, classification The TGA considers the descriptors 'N95' 'N99' and 'N100' to be a specific labelling claim where a device demonstrates conformity to NIOSH requirements against the United States Federal regulation for certifying air-purifying particulate respirators known as 42 Code of Federal Regulations Part 84 (or 42 CFR Part 84), or any national or However, for Class I non-sterile, non-measuring devices, you must submit the manufacturer's Declaration of Conformity with your application for inclusion in the ARTG. Non-compliant facemasks are subject to recall action consistent with our standard, non-pandemic approach. The sponsor must provide evidence of conformity to the TGA upon request. labeling, instruction for use, evidence of the performance of the device, and advertising material). AUSTRALIAN . Notifying the TGA of any lapse in certification is a legal requirement. the clock is stopped Oct 27, 2023 · Manufacturer's declaration of conformity; Manufacturer's certification/ declaration of conformity for systems and procedure packs and/or explanation how the kind of device is covered under the scope of the certificate (if required) Copy of the product labels; Pictorial images of the device; Packaging - inner and outer packaging; Instructions TGA CAC2 EU MDR4 EU MDD/AIMDD3 Japan MHLW/PMDA6 Health Canada7 US FDA8 HSA Singapore9 N/A Class III specified medical devices10 TGA CAC2 EU MDR4 EU MDD/AIMDD3 N/A 1 Declaration of conformity - under the Therapeutic Goods (Medical Devices) Regulations 2002 2 TGA CAC - TGA conformity assessment certificate Oct 20, 2023 · An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. If you select ‘Yes’, provide an estimated date for the new valid conformity assessment certification. Conformity assessment certification - supporting data form - initial and change applications for MDs including IVDs (pdf,510kb) Conformity assessment certification - supporting Evidence that a device has undergone an appropriate Australian conformity assessment procedure, or comparable overseas regulatory pathway, must be held by the manufacturer before a device can be included in the Australian Register of Therapeutic Goods (ARTG). Documented evidence may include one of the following: EC Certificate. The desk top review also reviews other inputs such as any additional supporting information provided by the applicant, and whether we have received any post market . Information on Australian evidence options including TGA conformity assessment certification. Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). The TGA has also revised this form to be more user friendly. For guidance on how your information will be treated by the TGA see: Treatment Conformity Assessment Supporting Data Form – Initial or change application (May 2023) For official use only. 93 (Standard for Medicinal Cannabis) by signing section 4 (declaration). Declaration of conformity templates (medical devices) Manufacturer Evidence (ME) constitutes a certificate that demonstrates that appropriate conformity assessment procedures have been applied by the manufacturer to a kind(s) of medical device(s). According to the guidance, the said person should duly sign a Declaration of Conformity in paper format, and then provide the authority with a scanned copy, while the Oct 15, 2020 · As a result, the TGA amended the Class I medical device inclusion process by revising and simplifying the Class I Declaration of Conformity (DoC) template form and introducing non-mandatory audits for some applications. Aug 31, 2023 · 31 August 2023. Manufacturers who apply for a TGA Conformity Assessment Certificate will be requested to complete a supporting data form and provide documents that detail specific parts of their quality management system. – Australia calculates timeframes based on ‘TGA business days’ (i. The Declaration of Conformity must be completed by the m anufacturer Commonwealth Consolidated Regulations. Except for Class I medical devices (no measuring function and/or not supplied sterile), Class 1 Oct 7, 2022 · The TGA is also increasing the use of assessment reports as the basis for abridgement of the assessment of an application for a TGA conformity assessment certificate. This is a declaration made in accordance with the requirements of Clause 6. Transfers of conformity assessment certificates (July 2017) PO Box 100 Woden ACT 2606 ABN 40 939 406 804.  Manufacturer's name: <Person responsible for manufacturing the conformity made under the legislative provisions of other jurisdictions, however the TGA requires a copy of a declaration of conformity that satisfies the Australian legislative requirements . THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - SCHEDULE 3. Page 5 of 51 . 1. Title of form (Month Year) MDB TEMP 2. Application for Australian Conformity Assessment Bodies Application form for an Australian Conformity Assessment Body determination. All time frames are given in TGA working days and start from the date the fee for electronic application for a Conformity Assessment Certificate is received. Important: This declaration of conformity (DoC) must be completed by the manufacturer of a Class I or a Class 1 in vitro diagnostic (IVD) medical device system or procedure pack. TGA USE ONLY. The Declaration of Conformity may be annexed to the STED. The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). Related guidance. Therapeutic Goods (Medical Devices) Regulations 2002 conformity made under the legislative provisions of other jurisdictions, however the TGA requires a copy of a declaration of conformity that satisfies the Australian legislative requirements . 6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. al mw xs fo co ix sk dh gj za