Our September MedTech news covers the latest updates and guidance from Europe, the US & Canada, and Asia Pacific. Read on for what’s made our headlines this month.
In European news…
New MDCG guidance on certification activities under MDR & IVDR
The MDCG has published guidance on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Intended for notified bodies, distributors and importers, the guidance assists with implementing quality management system requirements established by MDR and IVDR. Access the guidance here.
The latest from the US & Canada…
Open for comments: FDA draft guidance for denture base resins and facet screw systems
FDA draft guidance providing performance criteria for denture base resins and facet screw systems in support of the Safety and Performance Based Pathway is now open for comments. Under the guidance, manufacturers planning to submit a 510(k) using this pathway will have the option to use the outlined performance criteria to support substantial equivalence, rather than having to provide a direct performance comparison of the subject device and a predicate device.
Both guidance documents are open for comments until 29 October 2021, and can be accessed via the links below:
FDA Workshop: Transparency of AI/Machine Learning-enabled medical devices
The FDA will be holding a virtual public workshop on the transparency of Artificial Intelligence / Machine Learning (AI/ML)-enabled medical devices for patients, caregivers, and providers. Broadcast between 10am and 3.30pm ET on 14 October 2021, the workshop will discuss how the role of transparency enhances the safe and effective use of AI/ML-enabled medical devices, with a particular emphasis on information sharing methods such as labelling. Find out more here.
And for the FDA’s recently updated list of AI/ML-enabled medical devices marketed in the US, click here.
Drug and medical device shortages in Canada prompt modification of regulations
Shortages of drugs and medical devices is a growing issue for the Canadian market. Published on 1 September 2021, the Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) modify the Food and Drug Regulations and Medical Devices Regulations.
These new regulations have been created to help track, prevent, and mitigate shortages of key health products in Canada, including drugs and medical devices. Find out more here.
Updates from Asia Pacific…
China’s NMPA updates registration requirements for combination products
China’s NMPA has updated its registration requirements and processes concerning combination products that include drug-device components. The updates require Chinese market applicants to determine the primary mode of action of their combination product in order to identify the product’s appropriate NMPA regulatory pathway.
If applicants cannot independently determine the designation of their combination product, they may apply for designation determinations with the National Institutes for Food and Drug Control (NIFDC). Read more here.
India’s CDSCO releases new classification lists for medical device registrants
India’s CDSCO has published new risk-based classification lists covering several major device types. These latest lists cover six broad categories of device including Software, General Hospital, Nephrology and Renal care, PPE, Operation Theatre and Pain Management.
Australia’s TGA to accept CE mark for some high-risk medical devices
A CE mark for conformity assessments on some high-risk medical devices will now be accepted by Australia’s TGA. The Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 has been amended to specify additional kinds of conformity assessment documents that may be provided with an application for inclusion of certain Class III, Class AIMD and Class 4 IVD medical devices in the Australian Register of Therapeutic Goods. Find out more here.
That concludes our September MedTech news. Check back in October for more updates.
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