KD&A Can Help You From the Start – Medical Devices Steps to Market
Do you have a medical device and don’t know what to do? Medical devices include a wide range of products from bandages to heart valves and in most regions, the term medical devic
New Regulatory Changes for Medical Devices Containing Medicinal Substances, Animal, Microbial, or Recombinant Materials
As of 1 July 2024, new regulatory requirements for medical devices containing medicinal substances, or materials derived from animal, microbial, or recombinant sources will take ef
Updates to Medical Device Regulations
Various changes have been made to the regulation of numerous types of medical devices by the TGA, including software-based medical devices, prescription spectacle lenses, medical d
Considerations when outsourcing manufacture of medical devices
In the modern era of manufacturing its common for a company to make the decision to outsource part or full manufacturing of medical devices to a sub-contract manufacturer/critical
Important Changes in the Regulatory Framework for IVDs
Goods new for laboratories that manufacture Class 4 in-house IVDs. A new conformity assessment procedure has been introduced.
Therapeutic Goods Administration (TGA) Introduce Online Medical Device Incident Reporting (MDIR) System
The TGA have introduced a new online MDIR System for sponsors and manufacturers which is accessible via their eBusiness system (also used to submit applications). The eBusiness sys
Medical Device Single Audit Program (MDSAP)
The International Medical Device Regulators Forum (IMDRF) began work on developing documentation to facilitate the Medical Device Single Audit Program (MDSAP) in Singapore in 2012.
TGA Medical Device Reforms – Product Names Requirement Cancelled
The TGA have announced that a component of the medical device reforms outlined in the TGA blueprint will not go ahead. The initiative to record all devices included under a device
NZ Medical Device Recalls Remind Medical Device Suppliers to be Prepared
New Zealand (NZ)’s regulatory body for therapeutic goods, Medsafe, have issued a reminder to medical device suppliers to ensure they are suitability prepared for a recall should
Hip, Knee and Shoulder Joint Reclassification: Only 12 Months Remain
The TGA are working towards the deadline of 30 July 2014 to finalise the reclassification of total or partial hip, knee and should joints. In another step towards this deadline, th
