MEDICAL DEVICE APPROVALS

EN 60601-1-2, IEC 60601-1-2, EN 60601-1-1, IEC 60601-1-1, TGA Approval, TGA ARTG Listing, TGA Certification, Medical Device Approval, FDA 510(k) Approval, CE Medical Device Directive, CE MDD, EU Medical Device Regulation

Medical Device Approvals

Medical Devices must comply with specific medical Standards. Certain product classes must be certified and registered in various countries around the world. Click the links below for more information on specific Regulatory requirements.

EMC compliance for ACMA

Global Approvals – Medical Device Approvals Experts

Global Approvals are experts in Medical Device regulatory requirements. We have extensive experience is preparing International Regulatory Plans, EMC test plans, EMC Standards Gap Analysis, EMC testing of Medical Devices and certification/registration.

We arrange testing through accredited test laboratories and can help you certify and register your medical device through administrations such as the Australian TGA and US FDA.

We have 20 years of Medical Device Testing and Approvals experience and a wealth of knowledge at our disposal to get you to market quickly and efficiently.

Regulatory Plans

Global Approvals prepare comprehensive Regulatory Plans for international approval of Medical Devices.

We investigate and advise on applicable directives, regulations, standards and tests. We also cover certification and registration requirements, record keeping and labelling requirements.

Typical markets covered include Australia (ACMA RCM and the TGA), European EU member states (CE marking, MDD and MDR) and the USA (FDA 510(k)).

EMC Test Plans

EMC Testing to standards such as EN 60601-1-2 and IEC 60601-1-2 must be completed in accordance with a detailed EMC Test Plan.  We can prepare these plans for you and then arrange and manage the entire testing process. Global Approvals staff have comprehensive medical device EMC testing and EMC test plan preparation experience as former EMC Test Engineers and NATA signatories.

Gap Analysis

Standards are constantly evolving and in many countries, in particular the EU, a product must comply with current editions of the standards if it continues to be sold on the market. Transition periods are typically 2 or 3 years. Devices that are modified must also continue to comply with the relevant standards.

We can advise on what must be done to maintain compliance for every scenario. This is commonly called a “Gap Analysis”. Editions of the standards, Previous Test reports and current product specifications are analysed in order to determine which “Gaps” exist. Often additional testing is required to ensure the product is compliant with the new edition of the standard.

The most common Gap Analysis we perform is for IEC/EN 60601-1-2 (Edition 3 to Edition 4).

The Medical Device Regulation takes effect in May 2021. A comprehensive Gap Analysis  of your entire process including your QMS (Quality Management System) is highly recommended to ensure you are compliant with the new regulation.

Once gaps are identified necessary “top-up” activities can be arranged and managed.

EMC and Safety Testing

Medical devices must comply with EMC Standards such as EN 60601-1-2, IEC 60601-1-2, EN 55011 and CISPR 11.

All standards specify conducted and radiated emissions limits. EN/IEC 60601-1-2 also specified a series of immunity (susceptibility) tests.

Medical Devices must also comply with  Safety Standards such as EN 60601-1-1 or IEC 60601-1-1 (part 1, general) and applicable subparts in the series.

Global Approvals can arrange and manage testing through accredited test houses. We can witness testing, assist with failures and apply counter-measures to ensure you pass.

Common Medical Device Standards

  • EN 60601-1-2
  • IEC 60601-1-2
  • EN 60601-1-1
  • IEC 60601-1-1
  • EN 55011
  • CISPR 11
  • EN 12184
  • ISO 13485

Standards are available through SAI Global.

Project Management

Global Approvals staff have been involved in countless Medical Device Compliance projects over the past two decades, spanning EMC testing of Medical Devices to EN 60601-1-2 and CISPR 11, preparation of EMC Test Plans, preparation of Regulatory Plans, Gap Analysis assessments and certification/registration.

We can manage your project from start to finish so you can focus on core business activities:

  • Regulatory Plan preparation
  • Risk Assessment assistance
  • Gap Analysis (if necessary)
  • Test Plan preparation
  • Testing (arrange through accredited test houses, witness, problem solve)
  • Certification/registration submission (TGA, FDA etc)
  • Record keeping and labelling advice

 

TGA Approval in Australia

In Australia certain classes of medical devices fall under the jurisdiction of the Therapeutic Goods Administration (TGA) and must be registered on the Australian Register of Therapeutic Goods (ARTG).

 

Devices that require TGA approval are exempt from the ACMA EMC Labelling notice (ACMA RCM) but may have to comply with other ACMA notices.

 

Global Approvals can help you determine which Australian standards and regulatory instruments apply to your device and take you through the entire process.

 

If you are not based in Australia and do not have local representation Global Approvals can act as an Australian TGA Sponsor.

EMC compliance for ACMA

TGA Registration

Applicable electrical and electronic devices must be tested to standards such as EN/IEC 60601-1-2 (EMC) and EN/IEC 60601-1-1 (Safety) by accredited test laboratories.

If the device already has international certification such as EU CE marking or USA FDA 510(k) the process will be easier as these certifications are accepted as part of the registration process.

Test reports, certificates and associated documentation are submitted to the TGA along with a fee. If the submission is successful the device will be listed on the the (ARTG) and can be marketed for sale.

ACMA RCM

Devices that require TGA approval are exempt from the ACMA EMC Labelling notice (ACMA RCM). Devices that do not require TGA registration must comply with ACMA RCM EMC standard AS/NZS CISPR 11. ISM (Industrial, Scientific and Medical) devices under CISPR 11 are high risk and test reports must be accredited.

If the device has a radio transmitter it is not exempt from other ACMA regulatory requirements such as radiocommunications, telecommunications and EMR.

Click here for ACMA RCM information.

Australian TGA Sponsor

Global Approvals can act as your TGA Sponsor. We assume regulatory representation and register your medical device with the TGA. Appointing an independent sponsor is recommended, for the same reasons as an ACMA Agent.

FDA Approval in the USA

In the USA, Medical Devices must be approved by the FDA (Food and Drug Administration).

 

Global Approvals can help you determine which US rules and standards apply to your device.

EMC compliance for ACMA

FDA Submission

Global Approvals can assist with all aspects of your FDA 510(k) Submission.

For electrical and electronic medical devices, accredited IEC 60601-1-2 and IEC 60601-1-1 testing is required.

TIP: Existing test reports to IEC 60601-1-2 and IEC 60601-1-1 may not be acceptable, if testing was not completed at US power ratings (120VAC, 60Hz).

FCC

Medical Device Equipment is exempt from FCC Part 15B rules. Medical devices with Radio Transceivers must also comply with FCC Part 15C rules.

Click here for FCC information.

CE Marking in the EU

In Europe (EU member states) Medical Devices must comply with regulations such as the Medical Devices Directive (MDD), EU Medical Device Regulation 2017/745 (effective 2021) and In Vitro Diagnostics Regulation 2017/746 (effective 2022).

 

Medical devices with Radio Transceivers must also comply with the RED (Radio Equipment Directive).

 

We can help you determine which EU directives, regulations and standards apply to your medical device.

EMC compliance for ACMA

Medical Device Directive (MDD)

The MDD will be replaced by the MDR (see below) in May 2021.

Medical Device Regulation (MDR 2017/745)

Various standards apply such as EN 60601-1-2 (EMC) and EN 60601-1-1 (Safety). Compliance is based on an initial risk assessment and test plans are essential. All parties in the supply chain must have a comprehensive Quality Management System.

 

Other Healthcare Engineering Directives

  • In vitro diagnostic medical devices
  • In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746) – effective in 2022!
  • Active implantable medical devices

Contact Global Approvals for Expert Medical Device Compliance Services!

Global Approvals

PO Box 4356
Wantirna South, Victoria 3152, Australia

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