Share on LinkedInShare on LinkedInShare on FacebookShare on FacebookTweet thisTweet this

Life Sciences

Categories

Minimize menuMaximize menu

Minimize menuMaximize menuHomeLife SciencesMedical DevicesAudit, Certification & VerificationCertificationAustralia MRA - Australian Medical Devices Regulations

Related Services & Resources

Australia MRA - Australian Medical Devices Regulations

SGS is an approved medical devices certification body under the Mutual Recognition Agreement with Australia (MRA). Only a few Notified Bodies such as SGS have been approved by the Therapeutic Goods Administration (TGA) under this MRA for the Australian medical devices regulations.

The Australian Therapeutic Goods (Medical Devices) Regulations 2002 are, in many ways, similar to the equivalent EC directive. Low risk devices can be registered and sold on the basis of our CE marking certification. Higher risk devices require specific documentation assessment by SGS in our capacity as a TGA approved conformity assessment body.

Although our CE mark certification and United Kingdom Accreditation Service (UKAS) accredited ISO 13485:2003 certification will assist the approval of all medical devices in Australia, only manufacturers situated in Europe can be offered certification directly under the MRA.

SGS is your ideal certification partner for Australia MRA certification, allowing you to sell your medical devices in Australia often with no extra assessment. It is expected that a future change in regulations will give manufacturers who use MRA approved certification bodies even more advantages.

Email us
Medical Devices Brochure Medical Devices Brochure Audits, Certification & Training ...
Medical DeviceRegulations White PaperMedical Device Regulations White PaperAbout MD market entry regulations in 13 main markets (PDF 2.55 MB) ...
ELECTRO - MEDICALDEVICES SERVICE BROCHUREElectro Medical Devices in Trusted HandsFor an industry where timing is everything, SGS offers medical device manufacturers a globally integrated solution to get their new devices to market ...

Contact

SGS Headquarters

  • 1 Place des Alpes
    P.O. Box 2152
    Geneva, 1211
    Switzerland
  • t   +41 22 739 91 11
  • f   +41 22 739 98 86
  • e   Email us

E-SUBSCRIPTIONS

Sign up to SGS publications and newsletters from your region and around the world
STAY UP TO DATE.SUBSCRIBE NOW

Office Directory

Find SGS offices and labs around the world.World map
Office Locator

News

events