EasiMed Pty Ltd
EasiMed Pty Ltd is an Australian TGA Sponsor and a leading supplier and service provider of medical, dental, and veterinary equipment in Adelaide, South Australia. They offer comprehensive services including sales, installation, after-sales support, maintenance, calibration, and repair.
EasiMed Pty Ltd, based in Adelaide, South Australia, serves as a crucial Australian TGA Sponsor, facilitating the entry of medical devices into the Australian market for overseas manufacturers. They provide essential regulatory support, ensuring compliance with Therapeutic Goods Administration requirements. As a direct supplier of medical, dental, and veterinary equipment, EasiMed is committed to sourcing the best products and offering competitive pricing. Their services extend beyond sales to include hands-on installation, setup, after-sales support, and ongoing maintenance. They specialize in autoclave steriliser services, medical equipment servicing, and surgical instrument repairs, including endoscopes. EasiMed's expertise also encompasses preventive maintenance, medical equipment service contracts, and accreditation testing in accordance with Australian Standards. They offer quick response services for equipment breakdowns and repairs, ensuring minimal disruption to healthcare operations. Their team of professionally trained biomedical technicians provides high-standard biomedical engineering support, focusing on customer satisfaction and the longevity of medical equipment.
About
**Who they are**
EasiMed Pty Ltd is an Australian company based in Adelaide, South Australia, specializing in the supply and service of medical, dental, and veterinary equipment. They act as a TGA Sponsor, assisting overseas manufacturers in navigating Australian regulatory requirements.
**Expertise & scope**
* Australian TGA Sponsor services, including ARTG application support and acting as the official point of contact for the TGA.
* Regulatory support to comply with Therapeutic Goods Administration requirements.
* Sales, installation, after-sales support, maintenance, calibration, and repair of medical, dental, and veterinary equipment.
* Accreditation testing services for medical equipment in accordance with AS/NZS 3551:2012.
* Service and repair for autoclaves, sterilizers, surgical instruments, and endoscopes.
* Preventive maintenance and service contracts for medical equipment.
**Reputation / proof points**
* Family-owned business with a customer-centered approach.
* Commitment to providing cost-effective, professional biomedical engineering services.
* Focus on customer satisfaction and tailored service to meet business needs.
EasiMed Pty Ltd is an Australian company based in Adelaide, South Australia, specializing in the supply and service of medical, dental, and veterinary equipment. They act as a TGA Sponsor, assisting overseas manufacturers in navigating Australian regulatory requirements.
**Expertise & scope**
* Australian TGA Sponsor services, including ARTG application support and acting as the official point of contact for the TGA.
* Regulatory support to comply with Therapeutic Goods Administration requirements.
* Sales, installation, after-sales support, maintenance, calibration, and repair of medical, dental, and veterinary equipment.
* Accreditation testing services for medical equipment in accordance with AS/NZS 3551:2012.
* Service and repair for autoclaves, sterilizers, surgical instruments, and endoscopes.
* Preventive maintenance and service contracts for medical equipment.
**Reputation / proof points**
* Family-owned business with a customer-centered approach.
* Commitment to providing cost-effective, professional biomedical engineering services.
* Focus on customer satisfaction and tailored service to meet business needs.
Additional information
EasiMed Pty Ltd offers comprehensive support for medical device manufacturers seeking to enter the Australian market. Their services as an Australian TGA Sponsor are crucial for overseas companies, as Australian regulations require a local entity to take legal responsibility for ARTG applications and serve as the official contact for the TGA. This includes ensuring an Australian address is associated with the device prior to its inclusion on the ARTG. Beyond regulatory assistance, EasiMed provides ongoing post-sales support, tailored to manufacturer requirements, ensuring continued compliance and market presence.
Key Highlights
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Acts as an Australian TGA Sponsor, assisting overseas manufacturers with ARTG applications and regulatory compliance.
Source
“Manufacturers outside Australia are unable to be sponsor for their medical devices. We can be your Australian Sponsor and get your application underway.”
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Provides comprehensive biomedical equipment services including sales, installation, after-sales support, maintenance, calibration, and repair.
Source
“They offer comprehensive services including sales, installation, after-sales support, maintenance, calibration, and repair.”
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Offers accreditation testing for medical equipment in accordance with AS/NZS 3551:2012 management programs.
Source
“We provide accurate, effective and timely accreditation testing service for an extensive range of medical equipment that require performance verification, visual and physical inspection, maintenance, calibration and electrical safety test in accordance with AS/NZS 3551:2012 management programs.”
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Specializes in the service and repair of autoclaves, sterilizers, surgical instruments, and endoscopes.
Source
“Surgical instruments Endoscopes repair; Autoclave Steriliser Service”
Certifications & Trust Signals
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Established Australian entity providing TGA sponsorship and regulatory support.
Source
“The Australian Therapeutic Goods (Medical Device) Regulations requires an Australian address to be associated with any in vitro diagnostic or medical device prior to inclusion on the ARTG.”
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Family-owned business based in Adelaide, South Australia, with a focus on customer satisfaction.
Source
“We are a family owned business based in Adelaide, South Australia. EasiMed is customer-centred and aims to provide the highest cost-effective biomedical engineering services through our continuous efforts and innovation.”
Buyer Snapshot
Best for
- Overseas medical device manufacturers seeking Australian TGA sponsorship.
- Australian healthcare facilities requiring equipment service and maintenance.
- Businesses needing accredited testing and calibration for medical equipment.
How engagement typically works
- Customer-centered and responsive service.
- Tailored solutions to meet specific business needs.
- Focus on effective processes and clear communication.
Typical deliverables
- ARTG application support and TGA sponsorship.
- Medical, dental, and veterinary equipment sales and installation.
- Equipment maintenance, calibration, and repair services.
- Accreditation testing reports.
- Service contracts.
Good to know
- Best when requiring a local Australian entity for TGA regulatory compliance.
- Best when seeking a provider with expertise in medical equipment servicing and repair.
HQ:
Adelaide, AU
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, Orthopedics, Implants
Portfolio:
1-5
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
AUD 2,000
Included services:
Change notification and variation assessment, eBusiness Services account setup support, Sponsor address and labeling review, TGA device classification and grouping
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Australian Entity State:
Victoria
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
Additional tga_sponsor_au Details
Supports Artg
true
Australian Entity State
South Australia
Onboarding Steps
ARTG Application to register or include medical device in the Australian Register of Therapeutic Goods (ARTG) need an Australian person or company to take legal responsibility for the application and be the official point of contact for TGA. The Australian Therapeutic Goods (Medical Device) Regulations requires an Australian address to be associated with any in vitro diagnostic or medical device prior to inclusion on the ARTG.
