Medical Devices must be registered with the Australian Health Authority, the Therapeutic Goods Administration (TGA) before they are authorised for supply in the market.
Respective Medical Device applications are submitted by the Australian sponsor for assessment and where the risk classification is greater than I (inclusive of Is and Im), a European CE Certificate is used as one of TGA’s key assessable documents to qualify that the product has met the EU directive 93/42/eec or 90/385/eec.
CE certificates are issued by Notified Bodies to manufacturers in their capacity either as ORIGINAL EQUIPMENT (medical device) Manufacturers(OEM) or OWN BRAND LABELLING Manufacturers(OBL).
Following the publication of EU recommendation 2013/473/EU, OBL CE certification of Medical Devices,will no longer apply from 1 December 2016. In that circumstance, product registrations with the TGA using the OBL approach will no longer be valid.
EU recommendation 2013/473/EU now dictates that a full conformity assessment by the certifying Notified Body must be carried out as per applicable directives when compared to the previous reduced assessments on OBL manufacturers.
The current OBL manufacturer must hold the complete technical file for related approved products covered in the scope of his new CE certification.
Unless the OEM manufacturer is willing to share all product related design, process documentation etc., an unlikely contractual agreement in most situations, the OBL certification will be terminated on 1 December 2016 by the respective Notified Body.
Such decision will affect many thousands of products currently on the Australian Register of Therapeutic Goods (ARTG) and potentially many more thousands of approved products in other regulated countries where regulatory requirements include the submission of CE certificates.
To summarise, if the manufacturer cannot support EU recommendation 2013/473/EUto support continual certification, the Australian sponsor can no longer supply the device in Australia after 1 December 2016.
RQSolutions (www.rqsolutions.com.au) is a team of strategic professionals with over 35 years in Medical Device Sponsorship, Registrations, Government Reimbursement and Quality Management in the Therapeutic Goods Industry.
Let us share with you, the various available options to register your Medical Devices in Australia. We look forward to hearing from you.
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