USA (FDA)

Guidance on Non-Clinical Assessment of Tissue Containment Systems

FDA has issued guidance outlining non-clinical testing recommendations for tissue containment systems used during gynecologic and general-use power morcellation procedures. The document details test methods to meet special controls under 21 CFR 884.4050(b)(4) and 21 CFR 878.4825(b)(4) to support 510(k) submissions.

Q-Submission Program for Device Sponsors

FDA’s Q-Submission Program provides pathways for sponsors to request written or meeting-based feedback on IDEs, PMAs, HDEs, De Novo requests, 510(k)s, CLIA waiver applications, accessory classifications, and certain CBER-regulated INDs and BLAs.

EUROPE

Notified Body Confirmation Letter Template under Regulation (EU) 2023/607

A new template supports verification of formal applications, written agreements, and surveillance activities for manufacturers transitioning under the MDR and IVDR extension rules.

MDCG 2020-3 Rev.1 – Significant Changes under MDR Article 120

Updated guidance clarifies what constitutes “significant changes in design or intended purpose” for legacy MDD/AIMDD devices transitioning under Article 120 MDR. Revisions align the guidance with IVD transition principles and Regulation (EU) 2023/607.

Commission Guidance on Clinical Investigation Report Summaries

This guidance explains the required content and structure for clinical investigation report summaries submitted under Article 77(6) MDR, ensuring clarity and accessibility for intended device users.

FINLAND (FIMEA)

New Emergency Notification Regulation

Regulation 1/2023 introduces updated requirements for professional users reporting hazardous medical device incidents. Changes include harmonizing hazard classifications with manufacturers’ classifications and clarifying how devices involved in incidents are handled.

EU Instructions on Clinical Trial Report Summaries

The European Commission has published requirements for clinical trial report summaries, which must be submitted to authorities within one year of study completion and will be made publicly available in EUDAMED.

RoHS Requirements Apply to Medical Devices

Finland reiterates that RoHS restrictions on hazardous substances apply to medical electrical and electronic devices, supporting safety, environmental protection, and improved recyclability.

SPAIN (AEMPS)

New CNCps Procedure for MDD Certificate Validity Confirmation

AEMPS outlines procedures for verifying manufacturers’ written agreements with Notified Bodies to legally continue marketing legacy MDD-compliant devices under Regulation (EU) 2023/607.

Updated List of CE-Marked Filler Implants

AEMPS has updated its public list of approved filler implants intended for aesthetic and reconstructive purposes, including information on applicable regulatory classifications and botulinum toxin–containing medicinal products used cosmetically.

UNITED KINGDOM (MHRA)

Innovative Devices Access Pathway (IDAP)

MHRA has introduced IDAP to provide coordinated regulatory and market access support for innovative technologies, enabling earlier patient access to safe and effective devices.

Acceptance of CE Marked Devices Extended

The UK government intends to extend acceptance of CE-marked devices beyond 30 June 2023 as part of the future UK medical device regulatory framework.

Additional MHRA Updates

MHRA issued updated guidance on:

• Off-label use of medical devices
• Requirements for Class I medical devices
• Legal requirements for prosthetic, orthotic, and ophthalmic devices
• DEHP-containing devices
• Virtual manufacturing
• Software as a medical device (SaMD) vigilance
• Fees for 2023–2024
• Clinical investigation notifications and validation checklists

ASIA

MALAYSIA (MDA)

Third Edition Guidance on Medical Face Masks & Respirators

Updated guidance clarifies regulatory requirements for medical face masks and respirators under Act 737.

Market Surveillance Findings: Unregistered Medical Devices

MDA reported enforcement actions following identification of unregistered devices used in chiropractic and physiotherapy centers.

Transition to Electronic Registration Certificates

From 2 May 2023, medical device registration certificates are available electronically. Full transition will occur on 1 January 2024.

Expired EC Certificates Allowed Under Conditions

MDA will temporarily accept expired CE certificates for registration verification if devices continue to meet Directive 90/385/EEC or 93/42/EEC requirements and have no significant design or intended purpose changes.

CHINA (NMPA)

Guidelines on Quality Management for Transportation & Storage Enterprises

New on-site inspection principles apply to enterprises specializing in medical device storage and transportation.

Guidance on Registration of Recombinant Collagen Dressings

NMPA released guidelines covering raw material requirements, quality controls, and evaluation methods for recombinant collagen wound dressings.

Calls for Participation in Drafting New Guidance

NMPA is seeking industry participation in developing and revising multiple guidelines, including absorbable sutures, anti-adhesion products, dialyzers, and hydrocephalus shunts.

Guidance on Intervertebral Fusion Device Evaluation

New guidelines outline clinical evaluation requirements for conventionally designed intervertebral fusion devices (Class III).

INDIA (CDSCO)

Updated List of IVD Performance Evaluation Laboratories

CDSCO has renewed its list of approved laboratories for IVD performance evaluations.

National Medical Devices Policy 2023

India’s new policy aims to streamline device regulation, reduce compliance burden, and support sector growth across electronic equipment, implants, disposables, surgical instruments, and IVDs.

SINGAPORE (HSA)

Consultation on GN-14 IVD Risk Classification

HSA released updated guidance on IVD risk classification to ensure regulatory controls match device risk profiles.

HSA Recognized as WHO SRA for Class C & D IVDs

This recognition enables abridged WHO prequalification for qualifying IVDs, supporting faster global market access.