??13. March 2023

?? FDA Final Guidance:

?? Enforcement Policy for Face Masks and Barrier Face Coverings?

?? Enforcement Policy for Face Shields, Surgical Masks, and Respirators

?? Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications

This guidance describes the FDA’s recommendations regarding:

1. when clinical DDI studies with ARAs are needed;
2. the design of such clinical DDI studies;
3. how to interpret these study results; and
4. communicating these findings in drug product labeling.

?? Medicines and Healthcare products Regulatory Agency , Office for Life Sciences, Department of Health and Social Care

The three agencies issued a joint statement on Medical Devices Regulatory Reform:

• To help create a system wide UK integrated pathway for HealthTech, MHRA to become a more responsive regulator with supportive innovation pathways
• To ensure the supply of safe medical devices to UK patients is maintained through expanded recognition (e.g. to US approvals) and removing burden where possible.
• To ensure the future of the system through the development of a UK regulatory skill programme.

?? European Commission

??Council voted on the Medical Device Regulation extension

EU Council adopted the first reading of the amendment proposal for?#MDR?extension and MDR /?#IVDR?removal of sell-off period in the Education Council today without amendments as expected.

• Next Steps: The proposed amendment is expected to be formally adopted by both the European Parliament and the Council on 15 March 2023. It will enter into force on the day of its publication in the Official Journal.

??European Reference Network Published: Clinical practice guidelines and clinical decision support tools programme.

This toolkit is a practical collection of 15 documents covering methodological handbooks and tools designed for the prioritization, evaluation, modification, creation, and implementation of Clinical Practice Guidelines (CPGs) and Clinical Decision Support Tools (CDSTs) for rare diseases. It has been specifically created for European Reference Networks (ERNs) and draws upon approaches that have broad international consensus.

??COMMISSION DELEGATED REGULATION (EU) 2023/503

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Amendment to EU IVDR article 40: The frequency of re-assessment of Notified Body compliance by competent authorities has been changed from 3 to 5 years.

??Actions from: SCCS - Minutes of the Working Group meeting on Nanomaterials in Cosmetic Products

• HAP-Hydroxyapatite (nano) – the preliminary opinion has been adopted and published for commenting.
• Fullerenes (nano) – additional data was received from the Notifier, and is to finalise an opinion for comment by the March plenary for further discussion
• The working group plans the newest version of the?Nano Guidance – Update to be presented at the March plenary for further discussion

??MDCG work in progress - Ongoing guidance documents

The Medical Device Coordination Group published a table of on-going work with planned endorsement dates.

?? Swissmedic

??Guidance: Periodic Safety Update Report PSUR for veterinary medicinal products:

The Swissmedic PSUR/Annual report Guidance for veterinary medicinal products outlines the requirements for the submission. It provides guidance on:

• Content and format of the reports.
• Time limits and periodicity.
• Documentation format.

??Information Sheet: Out-of-Stock Situation

To bridge a supply shortage of important medicines that are authorized in Switzerland but currently out of stock.

This information sheet explains the legal basis, responsibilities, and requirements for obtaining permission to sell a foreign medicine in Switzerland.

Formular: Gesuch vorübergehender Vertrieb Arzneimittel ausl?ndische Aufmachung

?? Ministry of Food and Drug Safety of Republic of Korea

Guidance: "?????????? ???????????????????? ???? ?????? ?????????????????? ???? ??-?????? ??????????????????????????(?????????????? ????, ????????)" ???? ?????????????? ??-?????? ???????????? ??????????????, ?????????? ?????? ???????? ??????????????, ?????? ???? ?????????????????????? ?????????????????????????? ????????????????????.

?? Health Sciences Authority Ministry of Health (Singapore)

Guidance: Change Notification for Registered Medical Devices Rev. 5.0

For medical devices that are registered on the Singapore Medical Device Register (SMDR). This guidance is intended to aid registrants in determining if a Change Notification has to be submitted for Medical devices that undergo changes as part of their product life cycle.

?? Medical Device Authority The Ministry of Health Malaysia

Guidance: Classification of products used for: rehabilitation, physiotherapy and speech therapy based on their intended purpose.?

??Ministry of Health Vietnam Asia Actual

EXTENDS VALIDITY OF MEDICAL DEVICE IMPORT LICENSES

On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (“Decree 07/2023”), which among other items, automatically extended the validity of existing Import Licenses to December 31, 2024. This comes after significant delays implementing the new regulations (Decree 98/2021) released at the end of 2021.

??Up & Coming Dates: 15 March 2023: formal adoption Medical Device Regulation extension

• Belgium, Brussels 27- 31 March 2023: The 23rd Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF)
• 19. April 2023: EU Health Policy Platform Annual Meeting - Stakeholders’ Dialogue: Joint Statements, Study results and discussion.
• Pharma Ed’s?Combination Products Summit 2023 May 16-17 | Philadelphia PA
• MedTech Leading Voice #mlv inaugural issue Monday, 20. March 2023 from Sean Smith & illumino.co