??Medtech Leading Voice Regulatory Roundup 20. March
Martin King
????????????????????? ?????????????? & ?????????????? ?????????????????? ???????????? | Open to New Challenges | Medical Device, IVD | Navigating FDA, IVDR, MDR, PRRC | ISO Lead Auditor | ??.????????@??????????????.????
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??USA FDA have published:?
??Draft Guidance:?Questions and Answers?- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations.?
??Draft Guidance: Development of Local?Anesthetic?Drug Products with Prolonged Duration of Effect (for product developers)
??Final Guidance: The Use of Published Literature in Support of New Animal Drug Approvals.
??Draft Guidance: Drug?Approvals.Pharmacogenomic?Data Submissions
This guidance is intended to facilitate progress in the field of pharmacogenomics and the use of pharmacogenomic data in drug development.
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??? Swissmedic have published guidance that can be downloaded from the following links:
???Swissmedic?have published a Contractual Terms for e-Gov Clinical Trial services:
Terms of use Master CT contract sets out the legal framework and the terms for using the?eGov?CT service.
Terms of use Master CT contract be downloaded from the following link:?
???Swissmedic?have published Templates and Forms:
?Patient information template for homeopathic and?anthroposophic?medicinal products
?Patient information for herbal medicinal products
?Renewal_of_authorisation???(authorisation is typically 5 years but?Swissmedic?is entitled to grant a shorter authorisation)
??European Medicines Agency Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
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?? European Commission have published a Notice: 2023 annual Union work programme for European standardisations.
This Identifies the European standards and European standardisation deliverables that the Commission intends to request for 2023.?
To identify applicable text in the document, search the document for keyword “medical”.
?? European Commission
??The European Council Council have adopted: The amendment proposal for?extension dates of #MDR /?#IVDR ?removal of sell-off period. Effective, in law, as of 20. March 2023.
?Class IIa, “other class” IIb and Class I legacy devices have until 31. December 2028 to become MDR compliant.
Class IIb and Class III legacy devices have until 31. December 2027 to become MDR compliant.?BUT to qualify manufacturers need to have a QMS in place,?sign an agreement, apply for conformity assessment with a Notified Body and place the product on the market under MDD/IVDD by 26. May 2024.
Some useful summary text can be found here:
?? European Commission have switched the UDI Helpdesk to Live:
The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system.
?? UK Letter from the UK Government Chief Scientific Adviser
This Letter gives some insight of the Medicines and Healthcare products Regulatory Agency intended broader approach to the mutual recognition of products already approved by trusted international partner organisations and?a rigorous surveillance process (Post Market Surveillance).
?? The Egyptian Drug Authority (EDA):?
Issued a?regulatory guidance?for the import and registration of medical and laboratory supplies and devices and diagnostic reagents that are traded in?Great Britain (England - Wales - Scotland) and are not required to be traded in the European Union.
Announced?the?availability?of the (EDA Naming Checker) program for the initial evaluation of the trade names of the?preparations (veterinary - cosmetic - herbal)?as previously, which allows the?possibility of determining the similarity and the degree of?risk?for the names provided and querying-.?
Registration is done through?the?Username & Password?of the Electronic Companies Register?(Company Profile)
??CDSCO FDA India MoHFW
The Central Drugs Standard Control Organisation (CDSCO) have published:
??Ministry of Food and Drug Safety of Republic of Korea
?Revised the "Regulations on Designation of In Vitro Diagnostic Medical Device Clinical Performance Testing Institutions and Training of Workers“ (online 8 hrs)
?Held an online 'Medical Device Cybersecurity Business Briefing' for medical device manufacturers and importers on examination cases and submitted materials on cyber security evaluated during licensing.
?? International Council for Harmonisation:
The ICH S12 Guideline reaches Step 4 of the ICH Process
?? Some things I have spotted on LinkedIn: