The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidance for its transition to new medical device rules. Read more “New medical device rules in the Philippines”
Category: Medical device
Keep up to date with the latest medical device news in the pharmaceutical industry.
EC update on how to ensure a successful transition to the incoming device regulations
The European Commission (EC) has recently released updates aimed at ensuring all stakeholders are prepared for the transition to the European Union (EU) In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). Read more “EC update on how to ensure a successful transition to the incoming device regulations”
A summary of recent TGA regulatory updates
As Australia continues to improve its regulatory framework, the Therapeutic Goods Administration (TGA) has regularly released new and updated materials concerning the regulation of both medicines and devices. A summary of the recent updates are provided below. Read more “A summary of recent TGA regulatory updates”
Detailed guidance on the Target Development Profile Toolkit
When the Innovative Licensing and Access Pathway (ILAP) was launched at the start of 2021, it was announced that the Target Development Profile (TDP) will be available to applicants to support their application through this pathway. Read more “Detailed guidance on the Target Development Profile Toolkit”
Conducting clinical trials of a medical device in Switzerland
Following an earlier announcement from the Swiss Federal Council on the revision of the Ordinance on clinical trials with medica devices (ClinO-MD), Swissmedic has recently released practical advice for applicants on the transition to the new regulation. Read more “Conducting clinical trials of a medical device in Switzerland”
MDCG outlines regulation of custom-made devices under EU MDR
The European Commission’s (EC) Medical Device Coordination Group (MDCG) has recently released a Q&A document covering the most pertinent questions that arise from the regulation of custom-made medical devices under the European Union Medical Device Regulation (EU MDR). Read more “MDCG outlines regulation of custom-made devices under EU MDR”
Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit
A combination of newly released and recently updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) clarifies the requirements and procedures for the importing of medicines and devices into Northern Ireland (NI) following the end of the transition period. Read more “Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit”
IMDRF consultation on device regulatory reviews conducted by Conformity Assessment Bodies
The International Medical Device Regulators Forum (IMDRF) has a draft guidance document released for public consultation on the regulatory review of medical devices performed by Conformity Assessment Bodies (CABs). Read more “IMDRF consultation on device regulatory reviews conducted by Conformity Assessment Bodies”
MDCG releases guidance on alternatives to EUDAMED
The European Commission’s (EC) Medical Device Coordination Group (MDCG) has recently issued guidance on harmonised administrative practices and alternative technical solutions to be used until the European database on medical devices (EUDAMED) is fully functional. Read more “MDCG releases guidance on alternatives to EUDAMED”
Australia’s TGA continues to revamp its medical device regulations
The Australian Therapeutic Goods Administration (TGA) has released more medical device related regulatory guidance as the agency continues to reform its medical device regulations. Read more “Australia’s TGA continues to revamp its medical device regulations”