Australian TGA to Accept Medical Device Approvals from Additional Overseas Regulators
Emergo in the News | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Australia’s Therapeutic Goods Administration (TGA) plans to begin accepting certifications and approvals from additional foreign medical device regulators in addition to European CE Marking from market applicants.
- TGA will recognize registrations and certifications from US FDA, Health Canada, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and Medical Device Single Audit Program (MDSAP) auditing organizations.
- Australian market applicants may leverage approvals and registrations from these agencies for expedited TGA premarket reviews.
In a push to expand public access to more medical devices and technologies, the Australian Therapeutic Goods Administration (TGA) plans to begin accepting registrations and approvals from overseas regulators and assessment bodies beyond European Notified Bodies.
The TGA plan, first covered by Emergo in mid-2017, does not yet have a firm implementation date, but will be finalized “once the relevant legislative instrument(s) are in place,” according to the regulator.
Expanded number of comparable medical device regulators
Beyond conformity assessments issued by itself and CE Mark certifications from European Notified Bodies, TGA will also begin accepting registrations and approvals from the following entities:
- US Food and Drug Administration
- Health Canada
- Medical Device Single Audit Program (MDSAP) audit organizations
- Japan’s Pharmaceutical and Medical Devices Agency (PMDA)
New guidance from TGA further explains which types of evidence from these regulatory bodies may be used by Australian market applicants to abridge the TGA conformity assessment process for faster commercialization in the country.
Beyond CE Marking for Manufacturer Evidence
Currently, Australian market applicants may only use European CE Marking as “Manufacturer Evidence” when registering with TGA. Following implementation of this new plan, Emergo anticipates that registrations, licenses and certifications from US FDA, Health Canada, MDSAP auditors and/or PMDA will also qualify as Manufacturer Evidence for TGA premarket reviews.