USA (FDA)
Cybersecurity in Medical Devices: Refuse to Accept Policy
The Consolidated Appropriations Act, 2023, enacted on December 29, 2022, amended the Federal Food, Drug, and Cosmetic Act to include Section 524B on medical device cybersecurity. These requirements become effective on March 29, 2023. Submissions made before this date are exempt from the new cybersecurity provisions.
General Considerations for Animal Studies
This guidance outlines recommendations for animal studies used to demonstrate the safety of medical devices, including aspects related to device performance and handling. It applies to IDEs, PMAs, 510(k)s, HDEs, and De Novo requests. It supplements but does not replace device‑specific guidance.
Soft (Hydrophilic) Daily Wear Contact Lenses – Safety and Performance Criteria This guidance provides performance benchmarks for submitters using the Safety and Performance Based Pathway
for daily wear soft contact lenses. These lenses are intended to correct refractive errors and are available as daily disposable or frequent‑replacement options. Lenses designed for presbyopia, cosmetic use, therapeutic use, keratoconus, special optical enhancements, or special functional characteristics fall outside the guidance scope.
EUROPE
SCHEER Guidance on Phthalates
Regulation (EU) 2017/745 requires the European Commission to mandate the development of guidelines regarding the benefit‑risk assessment of phthalates used in medical devices. The guidance, originally adopted in 2019, must be updated periodically based on evolving scientific knowledge.
Implementation Q&A for Regulation (EU) 2023/607
The amendment aims to extend MDR transition periods and eliminate “sell‑off” deadlines to ensure continuity of device availability without compromising safety. The Q&A document clarifies practical considerations for manufacturers and notified bodies during the extended transition.
Transition Period Amendments (Regulation (EU) 2023/607)
This regulation introduces staggered extensions to MDR transitional timelines and removes sell‑off deadlines. These measures help prevent device shortages while maintaining regulatory rigor.
Notified Body Reassessment Delays
To increase capacity for MDR and IVDR work, the Commission has extended notified body reassessment intervals from every four years to every five years, although some may still undergo earlier reassessments.
EMA Guideline on Computerised Systems in Clinical Trials
EMA has issued detailed guidance reflecting the increasing complexity of electronic systems used in clinical trials, including wearable technologies, AI tools, and electronic data capture. The updated guideline replaces earlier reflection papers and emphasizes data integrity, participant protection, and system reliability.
CECP Expert Opinions
Under MDR Annex IX, notified bodies must justify any deviation from expert panel recommendations, particularly when clinical evidence adequacy or benefit‑risk concerns are raised.
SWITZERLAND (SWISSMEDIC)
Alignment with EU MDR/IVDR Transitional Amendments
Swissmedic will enforce requirements aligned with EU amendments to maintain device availability during transition. Updates address prolonged certificate validity periods and removal of deadlines for placing devices on the market.
Class I Manufacturer Inspections
Swissmedic continues surveillance of Class I device manufacturers to ensure compliance with updated regulatory obligations. Manufacturers must notify Swissmedic and maintain conformity documentation.
FINLAND (FIMEA)
Extension of Transition Periods
EU amendments effective March 20, 2023, extend certificate validity and remove sale deadlines. Manufacturers must meet specific conditions to benefit from the extended timelines. Certificate validity now extends to 2027 or 2028 depending on device class.
EMA Pilot for Medical Device Clinical Trial Advice
EMA initiated a pilot program to provide scientific advice for clinical research related to medical devices. Priority is given to innovative devices, pediatric technologies, and products targeting unmet medical needs.
UNITED KINGDOM (MHRA)
Extension of CE Certificate Validity
Following EU changes, higher‑risk devices have extended compliance periods until December 31, 2027, and medium‑to‑low‑risk devices until December 31, 2028, provided certain conditions are met.
Registering Medical Devices
MHRA has updated its guidance on registering devices for the Great Britain and Northern Ireland markets, including documentation on account management and device registration.
Exporting Medical Devices
MHRA outlines the process for obtaining Certificates of Free Sale (CFS). Applicants remain responsible for ensuring compliance with export restrictions.
Intended Purpose for Software as a Medical Device (SaMD)
Guidance is provided to help manufacturers define accurate intended purpose statements. Clear definitions support safe use and regulatory compliance. Although primarily for SaMD, the principles may be useful for SiMD as well.
IRELAND (HPRA)
Extension of MDR Transitional Provisions
Manufacturers should review Regulation (EU) 2023/607 to determine applicability. Devices that meet criteria and hold certificates expiring after March 20, 2023, are eligible for extended transition.
Clinical Investigation Applications (Article 62 MDR)
Sponsors submitting clinical investigation applications must provide complete documentation within specified timeframes. Incomplete applications risk being deemed lapsed.
ASIA
JAPAN (PMDA)
Medical Safety Measures
Japan continues to enhance safety by improving naming, labeling, and specifications of medical devices. The IMDRF‑aligned glossary for medical device malfunctions has been updated to promote consistency in reporting.
Gender Differences in Clinical Trials
New guidelines require manufacturers to consider gender representation in study design, analysis, and reporting for medical device trials. These guidelines support comprehensive safety and performance evaluation.
INDIA (CDSCO)
Notified Bodies under MDR 2017
CDSCO has updated the list of notified bodies authorized to perform manufacturer site audits.
Medical Device Testing Laboratories
An updated list of MDTLs registered under MDR 2017 is available for manufacturers requiring device evaluation services.
SOUTH KOREA (MFDS)
International Harmonization and AI Guidelines
MFDS is working with GHWP to promote global regulatory alignment and support export of Korean medical devices. Korea is advocating adoption of its AI‑based diagnostic device review guidelines as international standards.
MALAYSIA (MDA)
Classification Guidance
MDA’s guidance clarifies whether rehabilitation, physiotherapy, and speech therapy products meet the legal definition of a medical device under Act 737.
Unregistered Devices
MDA continues market surveillance to prevent the sale of unregistered devices. Noncompliance may result in fines, imprisonment, or both.
Withdrawal of Registration Applications
Starting May 1, 2023, incomplete registration and change‑notification applications will be withdrawn if not completed within 30 working days.
CHINA (NMPA)
New Guidelines Issued
NMPA has released guidelines for dental adhesives and artificial shoulder prostheses. The guidance applies to standard device designs but excludes innovative or personalized implants.
Call for 2024 Standards Proposals
NMPA is soliciting proposals for the development of 2024 standards related to clinical evaluation and trial quality requirements.
SINGAPORE (HSA)
COVID‑19 Self‑Test Kit Announcements
HSA confirms that only PSAR‑authorized or fully registered COVID‑19 antigen self‑test kits may be supplied in Singapore.
Guidelines for Laboratory Developed Tests
GL‑08 explains regulatory expectations for LDTs developed and used within a single licensed laboratory.
PHILIPPINES (FDA)
Regulatory Flexibility for Certain Class B, C, and D Devices
Applications for CMDN for devices not included in the prior registrable list were accepted until March 31, 2023. Beginning April 1, 2023, companies must secure CMDR certificates. Extensions have been granted due to challenges with full implementation of AO 2018‑0002.
