With the Olympics still fresh in our minds, it seems fitting that the TGA announced their race times for the complete implementation of ISO 13485:2016 certification as opposed to ISO 13485:2003 acceptance.
On your marks…
In a recent blog, Custom Medical Devices TGA / ISO 13485:2016 Certification, we discussed the benefits and requirements of implementing an ISO 13485 certified Quality Management System (QMS) for companies developing custom-made medical devices. Certification can certainly increase the reputation of the company but the associated costs need to be considered. However, there are still requirements under the Therapeutic Goods (Medical Devices) Regulations 2002 to be met.
Both ISO 13485 certification standards will run in tandem until 01 Jan 2019. From that date, all certifications should be granted under the 2016 revision and any certifications to the 2003 revision must be expired. It is a little uncertain as to the acceptability of certificates in the period between 01 Jan and 01 March 2019. The assumption is that all certifications will comply with the 2016 revision before then, but any exceptions should be discussed with your regulator.
International regulators are already gearing up for the move to the new revision. Audit groups such as the Medical Devices Single Audit Program (MDSAP) must transition to using ISO 13485:2016 as their audit standard by 01 Jan 2019. In the meantime, they can audit to the current standard version unless specifically requested to use the new standard.
So what do you need to do?
It is up to the individual company to decide when they are going to apply the new revision of the standard. Preparation and gap analysis exercises should commence ASAP in order to allow sufficient time for any remediation activities.
The TGA has recommended that companies should consult with their regulatory bodies, both national and international, during the three-year transition period to optimise their strategies.
To help you get out of the blocks, you can visit this blog, Free ISO 13485:2016 Gap Analysis, where PharmOut has provided some advice for your consideration.