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On 16 December 2025, the EU published Proposal 2025/0404 (COD) to simplify MDR and IVDR requirements. Key measures include revised software classification rules, reduced re-certification obligations, expanded eIFU use, participation in MDSAP, increased flexibility for in-house devices, and new pathways for orphan and breakthrough innovations—aiming to reduce burden while maintaining patient safety.
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Regulatory Update
European Union
December 23, 2025
EU Proposal to Simplify MDR and IVDR Rules (2025)
On 16 December 2025, the EU published Proposal 2025/0404 (COD) to simplify MDR and IVDR requirements. Key measures include revised software classification rules, reduced re-certification obligations, expanded eIFU use, participation in MDSAP, increased flexibility for in-house devices, and new pathways for orphan and breakthrough innovations—aiming to reduce burden while maintaining patient safety.
Read full story
Regulatory Update
European Union
December 23, 2025
EU Draft Implementing Regulation on MDR/IVDR Notified Bodies (2025)
The European Commission published a draft implementing regulation on 12 December 2025 to harmonize MDR/IVDR notified body practices. The proposal clarifies Annex VII requirements, including quotation information, conformity assessment timelines, and re-certification processes. Open for feedback until 23 January 2026, the initiative aims to improve consistency, transparency, and predictability across notified bodies operating under EU medical device regulations.
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Regulatory Update
Brazil
December 23, 2025
ANVISA 2025 Manual for Health-Use Materials Registration
ANVISA’s 2025 manual for health-use materials registration standardizes requirements for medical device submissions in Brazil, aligned with RDC 751/2022. Manufacturers and importers can reduce errors, accelerate approvals, and improve application quality.
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Regulatory Update
United Kingdom
Singapore
December 17, 2025
Singapore HSA–UK Fast Track Pathway 2025
The Singapore HSA–UK Fast Track Pathway 2025 introduces a Regulatory Innovation Corridor between Singapore’s HSA and the UK’s MHRA. The initiative allows companies to seek joint regulatory advice, accelerating access to breakthrough therapies in areas such as cancer, rare diseases, gene therapy, and digital health. The pathway improves regulatory efficiency while maintaining safety and strengthens both countries’ roles as global life sciences hubs.
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Regulatory Update
Brazil
December 17, 2025
Brazil Anvisa Regulatory Agenda 2026–2027
The Brazil Anvisa Regulatory Agenda 2026–2027 sets out 161 priority topics that Anvisa plans to regulate or review over the next two years. Developed through public consultation and technical review, the agenda improves transparency and predictability across medicines, medical devices, food, cosmetics, and health services. It helps companies anticipate regulatory changes and plan compliance strategies more effectively.
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Regulatory Update
European Union
December 11, 2025
EU Commission 2025 Survey on Medical Device Availability
The EU Commission’s 2025 Economic Operator Survey examines medical device availability under MDR/IVDR using data from manufacturers, authorised representatives, importers, and distributors. It highlights certification delays, documentation challenges, and discontinuation of niche devices. The findings show increasing risks to EU supply continuity, emphasizing the need for early planning, complete technical documentation, and close collaboration with notified bodies.
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Regulatory Update
Malaysia
December 3, 2025
Malaysia Medical Device Import Permit Postponed to 1 July 2027
Malaysia’s Medical Device Import Permit enforcement, initially set for 2 January 2026, has been postponed to 1 July 2027. Until then, importers follow existing customs procedures. From 1 June 2026, stakeholders may voluntarily submit Verification Slips for non-medical devices under medical device tariff codes via the ePermit system. Local distributors are advised to review portfolios, update SOPs, and monitor the MDA portal for the latest guidance to ensure a smooth transition.
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Regulatory Update
Switzerland
December 2, 2025
Swissmedic launches swissdamed UDI playground
The swissdamed UDI Playground, launched in November 2025, gives economic operators a free testing environment to practise UDI XML uploads and data validation before the swissdamed UDI Devices module becomes mandatory. Registered companies can test versioning, onboarding, and UDI registration workflows. Swissmedic also provides a 13-page guide explaining access, actor registration, XML upload steps, and validation rules.
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Regulatory Update
European Union
December 2, 2025
EU EUDAMED mandatory modules official May 2026 timeline confirmed
The EU EUDAMED mandatory modules 2026 requirement comes from Decision (EU) 2025/2371, which confirms four modules—Actor Registration, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance—are fully functional. From 28 May 2026, manufacturers must register new MDR/IVDR devices before placing them on the EU market, while legacy devices must be registered by 28 November 2026. Certificates issued before that date must be uploaded by 28 May 2027.
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Regulatory Update
Brazil
November 26, 2025
Anvisa Modernization Plan 2025 – Medical Device Regulatory Progress
Anvisa’s 2025 Modernization Plan reduces the medical device post-registration backlog by 40%, shortens review times for biological products and clinical research, and clears radiopharmaceutical pipelines. The agency is investing 25 million reais in AI and hiring 102 new specialists, marking its largest team expansion since 2014. Queues are expected to be cut in half within six months, with full normalization within a year, improving efficiency, predictability, and regulatory support for medical device manufacturers in Brazil.
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Regulatory Update
United States
November 26, 2025
FDA Pre-RFD Guidance 2025 – How to Prepare a Pre-Request for Designation
The FDA Pre-RFD Guidance 2025 updates the 2018 version for combination product sponsors seeking preliminary, non-binding feedback. The guidance explains how to submit a Pre-Request for Designation, clarifying regulatory classification, responsible FDA centers (CDER, CBER, or CDRH), and meeting elements including materials, request format, and timelines. Early interaction supports planning, confirms regulatory assignment, and helps mitigate risks in development and marketing applications for drugs, devices, biologics, or combination products.
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Regulatory Update
European Union
November 26, 2025
ISO 10993-1:2025 Biological Evaluation of Medical Devices – Edition 6 Update
ISO 10993-1:2025 (Edition 6) revises the biological evaluation of medical devices, replacing Table A1 with a risk-based, lifecycle approach aligned with ISO 14971. Manufacturers must now focus on identifying actual biological hazards, exposure duration, and material characteristics, providing scientific justification for all tests. The update emphasizes safety throughout the device lifecycle rather than minimum required tests, shaping a more flexible, scientifically grounded approach for compliance and regulatory submissions.
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Regulatory Update
European Union
November 26, 2025
EU MDR 2017/745 & IVDR 2017/746 Pilot Coordinated Assessment 2025 Update
The EU MDR 2017/745 and IVDR 2017/746 pilot coordinated assessment lets sponsors submit one application for multinational clinical investigations and performance studies. The system streamlines approvals, reduces duplicative national submissions, and prepares Member States for mandatory coordinated assessment. Eligibility includes Class III and certain Class II devices, as well as IVD performance studies under Article 58. Sponsors must confirm intended use, documentation, and risk class before applying.
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Regulatory Update
Brazil
November 20, 2025
Brazil Anvisa 2025 Guidance on Medical Device Certificate Issuance
Anvisa’s 2025 medical device certificate tool replaces Sicert, offering integration with Solicita, new templates, translations, and previews. Companies must transition before December 1, 2025, when Sicert stops issuing new certificates. Certificates can be validated via QR code or Anvisa’s consultation system. The modernized process improves efficiency, security, and international alignment while reducing regulatory risk for manufacturers, importers, and distributors in Brazil.
Read full story
Regulatory Update
Brazil
November 11, 2025
Brazil Anvisa Announces Measures to Optimize Approval Queues
Anvisa’s 2025 reform introduces immediate and structural measures to reduce approval backlogs for medicines, medical devices, and clinical trials. The plan includes expanding staff, upgrading systems through AnvisAI, streamlining submissions, and deploying temporary task forces and risk-based inspections through 2026.
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Regulatory Update
Colombia
November 11, 2025
Colombia INVIMA 2026 Guidance Clarifies UDI-DI Requirements for Class IIa Medical Devices
Colombia’s INVIMA 2026 UDI-DI requirement mandates that Class IIa medical devices registered before February 2024 incorporate UDI-DI coding. The final deadline is February 9, 2026. Manufacturers should review their portfolios, follow submission instructions, and complete registration early to avoid noncompliance, additional fees, or interrupted commercialization. Compliance ensures devices remain valid under current INVIMA regulations.
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Regulatory Update
European Union
November 11, 2025
EU IVDR 2025 Update: New Guidance Clarifies Change Requirements for Companion Diagnostics
The updated Team NB guidance (29 October 2025, V2) clarifies IVDR Annex IX Section 5.2 for companion diagnostics (CDx). It outlines when changes to performance, suitability, or intended use require notified body approval through a new assessment or certificate supplement, with a flowchart to help manufacturers determine which changes are reportable.
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Regulatory Update
Brazil
November 3, 2025
Brazil ANVISA 2025 Regulation on Saline Solution Reclassification
ANVISA’s 2025 regulation reclassifies sodium-chloride saline solutions for nasal irrigation as Class IV medical devices under RDC 751/2022. Companies must complete transition their registrations from medicines to medical devices by May 30 2026. The rule clarifies transition conditions, GMP applicability, and stock-depletion policies, ensuring safer products and regulatory alignment with international standards.
Read full story
Regulatory Update
European Union
October 29, 2025
EU Commission Implementing Decision (EU) 2025/2078 on Harmonised Standards
Implementing Decision (EU) 2025/2078 updates harmonised standards for surgical drapes, gowns, clean air suits, medical face masks, and sterilizers under the EU MDR. The revised EN 13795, EN 14683, and EN 14180 standards ensure product safety, quality, and performance in line with the latest scientific developments. Manufacturers should update testing and documentation to maintain conformity and regulatory compliance.
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Regulatory Update
Malaysia
October 22, 2025
Malaysia MDA 2026 Update on Class A Medical Device Fees
Malaysia’s Medical Device (Amendment) Regulations 2025 [P.U.(A) 330] raise Class A medical device application fees from RM 100 to RM 500 and add a RM 750 registration fee effective 1 January 2026. Manufacturers must submit before 10 December 2025 to keep the current rate. The change supports MDA’s cost-recovery model and strengthens post-market surveillance in Malaysia’s device sector.
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Regulatory Update
United Kingdom
October 22, 2025
UK MHRA 2026 Guidance on Medical Device Registration Fees
The UK MHRA’s 2026 DORS Fees Guidance introduces annual medical device registration fees based on GMDN Level 2 categories. Manufacturers must update and verify registrations before 30 March 2026 and pay fees via DORS within 90 days. The change replaces one-off charges with an annual, category-based model aligned with MHRA post-market surveillance.
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Regulatory Update
Brazil
October 7, 2025
Anvisa Launches New Digital Channel for International Users
Brazil's 2025 Contact US form provides foreign users with a dedicated channel to submit questions and access regulatory information directly. This digital modernization effort enhances accessibility, transparency, and international engagement while traditional channels remain available for Brazilian users. The initiative simplifies regulatory communication, supports stakeholder engagement, and demonstrates Anvisa’s commitment to evolving global digital standards.
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Regulatory Update
United States
September 23, 2025
FDA Finalizes Guidance on Emergency Use of IVDs During Public Health Crises (2025)
In September 2025, the FDA finalized guidance on how it will authorize the emergency use of in vitro diagnostics (IVDs) during public health crises. Under FD&C Act section 564, the agency may permit unapproved IVDs when benefits outweigh risks, alternatives are limited, and risk controls are in place. The policy clarifies FDA’s enforcement discretion, aiming to balance timely patient care with safeguards against inaccurate results in emergencies.
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Regulatory Update
Switzerland
September 16, 2025
Switzerland 2025 Update on Good Practices for Endoscope Reprocessing
Swissmedic’s 2025 update to the Good Practices for Endoscope Reprocessing (GPAE) clarifies legal duties under the Swiss MedDO and aligns hygiene standards with the latest science. Prompted by compliance gaps revealed in hospital inspections, the guidance requires healthcare providers to update procedures, training, and documentation.
Read full story
Regulatory Update
European Union
September 16, 2025
EU 2025 Guidance on Borderline and Classification of Medical Devices
The European Commission’s 2025 Guidance on Borderline and Classification of Medical Devices introduces key updates under MDR and IVDR, including reclassification of SARS-CoV-2 tests, new rules for electronic Instructions for Use (eIFU), and streamlined PAR forms. These changes reduce uncertainty for manufacturers, support digital compliance, and accelerate market access across the EU.
Read full story
Regulatory Update
Philippines
September 10, 2025
Philippines FDA DC 2025-0382: Extension of Temporary Suspension on Medical Device Registration Fees
The Philippines FDA has extended its temporary suspension of 2025 medical device registration fees, granting manufacturers an additional 60 working days to register at legacy rates. This move, formalized under Department Circular No. 2025-0382, offers continued cost savings and a strategic window for market entry while the agency completes its review of the updated fee schedule.
Read full story
Regulatory Update
Canada
September 10, 2025
Health Canada eSTAR Pilot 2025: Streamlining Class III & IV Submissions
Health Canada’s 2025 eSTAR pilot expands digital submission capabilities for Class III and IV medical devices, including IVDDs, through a guided, interactive PDF template. The initiative aims to streamline regulatory processes and test a new content conversion tool aligned with IMDRF standards. Up to 30 eligible participants will be selected to take part.
Read full story
News
Australia
September 10, 2025
Australia TGA Targets AI and Software-Based Tools in 2025 Compliance Update
Australia’s TGA has released a 2025 compliance update clarifying how AI and software-based tools, such as digital scribes with diagnostic or treatment functions, may fall under medical device regulations. Developers must assess whether their products require inclusion in the ARTG and ensure compliance to avoid enforcement action.
Read full story
Regulatory Update
Malaysia
September 3, 2025
Malaysia MDA Launches First Regulatory Sandbox for Medical Devices (2025)
Malaysia’s Medical Device Authority (MDA) has launched its first regulatory sandbox, creating a controlled environment for testing AI-driven medical technologies. The initiative lets developers validate innovations under real-world conditions while MDA monitors safety, compliance, and performance. By bridging regulatory oversight with innovation, the sandbox is designed to fast-track safe, patient-centric devices into Malaysia’s healthcare system.
Read full story
Regulatory Update
Switzerland
September 3, 2025
Swissmedic 2024 Hospital Inspections Report: Compliance Gaps Identified
Swissmedic’s 2024 Hospital Inspections Report reveals widespread compliance gaps in Swiss hospitals’ medical device management, from weak quality systems and staff training to cybersecurity risks and inadequate vigilance reporting. Resource constraints, structural inefficiencies, and workforce shortages are cited as root causes. To close these gaps, Swissmedic urges hospitals to strengthen training, infrastructure, cybersecurity, and reporting practices to safeguard patient safety and regulatory compliance.
Read full story
Regulatory Update
European Union
September 3, 2025
EU MDCG 2024-14 Rev.1 Guidance on Master UDI-DI for Contact Lenses: 2025 Update
The European Commission’s MDCG 2024-14 Rev.1, published in August 2025, extends the compliance deadline for applying Master UDI-DI to contact lenses until 9 November 2026. The revision also references new guidance, including MDCG 2025-7 and resources on highly individualised devices, giving manufacturers more clarity. With extra time to update labeling, documentation, and vigilance processes, companies should use this transition period to prepare for full MDR compliance.
Read full story
Regulatory Update
Mexico
September 1, 2025
COFEPRIS Simplifies Medical Device Registration Procedures in Mexico
Mexico’s regulatory authority, COFEPRIS, has issued new measures to simplify medical device registration, including clearer application codes by risk class and reduced approval timelines. These updates aim to streamline market access for both domestic and international manufacturers while maintaining regulatory oversight.
Read full story
Regulatory Update
Switzerland
August 26, 2025
Swissmedic Launches swissdamed UDI Devices Module Ahead of 2026 Compliance Deadline
Swissmedic has activated the swissdamed UDI Devices module, marking a significant step toward mandatory medical device registration in Switzerland. While use of the system is currently voluntary, all medical devices, IVDs, and procedure packs must be registered by 1 July 2026.
Read full story
Regulatory Update
Malaysia
Singapore
August 25, 2025
Malaysia-Singapore 2025 MOU on Medical Device Regulatory Reliance
Malaysia’s MDA and Singapore’s HSA have launched a six-month Regulatory Reliance Pilot to streamline Class B–D medical device approvals. By leveraging each other’s reviews, the initiative cuts duplication, shortens timelines, and accelerates patient access to safe, innovative technologies. If successful, this program could evolve into a long-term ASEAN reliance framework, reshaping regional market entry.
Read full story
Regulatory Update
Brazil
August 18, 2025
Brazil Anatel Resolution 780/2025 on Telecom Product Homologation
Anatel’s new Resolution 780/2025 reshapes telecom compliance in Brazil. Marketplaces are now jointly liable for irregular sales, refurbished products face stricter requirements, and data centers must undergo conformity assessments. The update expands sanctions and applies the Consumer Protection Code, raising the stakes for manufacturers, importers, and digital platforms.
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Regulatory Update
Switzerland
August 12, 2025
Swissmedic 2025 Guidance on Systems and Procedure Packs
Swissmedic’s August 2025 update brings Switzerland’s systems and procedure pack (SPP) rules in line with EU MDR/IVDR, tightening requirements for registration, labelling, and vigilance reporting. Assemblers now have just three months to register with Swissmedic, and can expect random inspections to verify compliance.
Read full story
Regulatory Update
United States
August 7, 2025
FDA Medical Device User Fee Small Business Qualification 2025 Guidance Update
FDA’s 2025 user fee guidance updates small business fee waiver rules, detailing financial hardship criteria and replacing Forms 3602/3602A with Form 3602N. It supports small medical device companies by clarifying eligible documentation, including for entities in tax-exempt jurisdictions, to ease FDA registration costs and encourage market entry.
Read full story
Regulatory Update
European Union
August 7, 2025
EU Notified Bodies Survey 2025 on MDR and IVDR Certifications and Applications
The EU Notified Bodies Survey 2025 highlights rising MDR and IVDR certification activities but also ongoing challenges with capacity and documentation. Manufacturers should proactively plan their certification strategies to ensure timely compliance and market access across the European Union.
Read full story
Regulatory Update
Mexico
August 6, 2025
Mexico COFEPRIS 2025 Abbreviated Pathway for Medical Devices
Mexico’s COFEPRIS has introduced a new Abbreviated Regulatory Pathway, effective September 1, 2025, allowing medical device manufacturers to leverage prior approvals from IMDRF or MDSAP member authorities. This fast-track route reduces documentation requirements and mandates a 30-day decision timeline, aligning Mexico’s regulatory framework more closely with international standards.
Read full story
Regulatory Update
Malaysia
China
August 5, 2025
Malaysia–China Medical Device Reliance Programme Launches Pilot for IVD Fast-Track Access
Malaysia’s Medical Device Authority (MDA) and China’s NMPA have launched the Pilot Phase I of their 2025 Regulatory Reliance Programme, enabling expedited market access for in-vitro diagnostic (IVD) devices. Running from 30 July to 30 September 2025, this bilateral initiative allows qualified manufacturers in both countries to streamline approvals under mutual recognition.
Read full story
Regulatory Update
Brazil
August 1, 2025
ANVISA RDC 982/2025: Brazil's New Risk-Based Certification System
Brazil’s new RDC 982/2025 introduces a risk-based approach to Good Manufacturing and Distribution Practices, tying certification to product risk, compliance history, and recognized international audits. This shift streamlines ANVISA approvals, shortens timelines, and reduces redundant inspections for qualified companies.
Read full story
Regulatory Update
Brazil
July 29, 2025
Brazil Siscomex 2025: What Medical Device Importers Must Know
Brazil’s Siscomex system is introducing new Product Catalog requirements under Import Announcement No. 070/2025, with updates that directly affect how medical device import data must be described, classified, and aligned with ANVISA records. Starting in 2026, inconsistent or incomplete catalog entries could lead to customs delays, regulatory scrutiny, or even penalties.
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Regulatory Update
Philippines
July 24, 2025
Philippines FDA Temporarily Suspends Medical Device Registration Fees in 2025
The Philippines FDA has temporarily suspended its steep 2025 medical device registration fee hike, reverting to much lower legacy rates for 60 days starting June 10. This brief window offers manufacturers a chance to register at prices more than 10 times cheaper, making it a critical opportunity for cost savings and market entry.
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Regulatory Update
Singapore
July 23, 2025
Singapore HSA 2025 SaMD & CDSS Guidelines Update
Singapore’s HSA has updated its 2025 guidelines on SaMD and CDSS, aligning terminology with global standards and clarifying key classification rules. The revision helps developers determine if their software qualifies as a regulated medical device and what risk class applies, especially for AI-based or mobile platforms.
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Regulatory Update
Malaysia
China
July 23, 2025
Malaysia-China Medical Device Reliance 2025 Launch
Malaysia and China have signed a landmark mutual recognition agreement to fast-track medical device approvals between the two countries, effective 30 July 2025. The 2025 Regulatory Reliance Programme enables Malaysian IVDs to access China’s Green Channel and allows Chinese devices to enter Malaysia via an accelerated 30-day review.
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Regulatory Update
European Union
July 22, 2025
EU Guidance MDCG 2025-6 Clarifies Compliance for Medical Device AI
The EU has released new guidance clarifying how the Artificial Intelligence Act (AIA) applies to AI-enabled medical devices already regulated under MDR and IVDR. MDCG 2025-6 outlines what qualifies as high-risk Medical Device AI (MDAI) and how manufacturers can integrate AIA requirements—such as bias mitigation, transparency, and cybersecurity—into existing quality systems.
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Regulatory Update
Singapore
July 16, 2025
Singapore GN-21 Update 2025: What’s New for Medical Device Change Notifications
Singapore’s revised GN-21 guidance streamlines medical device change notification by expanding exemptions, clarifying pathways for machine learning-enabled devices, and introducing new UDI data requirements. These updates reduce regulatory burden while reinforcing oversight of post-market changes.
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Regulatory Update
Mexico
July 16, 2025
Mexico Acuerdo Dispositivos Médicos 2025 Update
Mexico’s updated Acuerdo Dispositivos Médicos Julio 2025 introduces major changes to the classification, registration, and exemption rules for low-risk medical devices. With new annexes, timelines, and GMP requirements now in effect, manufacturers must reassess their regulatory strategy to maintain market access.
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Regulatory Update
European Union
July 15, 2025
MDCG 2025-7 Clarifies Master UDI-DI Timelines for Optical Devices
The MDCG has published new guidance clarifying Master UDI-DI requirements for low-risk optical devices like contact lenses and spectacle frames under the MDR. The position paper outlines mandatory timelines for UDI labelling and EUDAMED registration, with full implementation phased in between 2026 and 2028.
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Regulatory Update
Vietnam
July 9, 2025
Vietnam MoH Reduces Medical Device Registration Fees by 50% Through 2026
Vietnam’s Ministry of Health has announced a temporary 50% reduction in government fees for medical device registration and licensing, effective from July 1, 2025, to December 31, 2026. The fee cut applies to new applications for circulation numbers, import/export licenses, testing certificates, and declarations of eligibility, offering cost relief for manufacturers entering or expanding in the Vietnamese market.
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Regulatory Update
Brazil
July 8, 2025
Brazil Anvisa UDI System 2025 Launch: Medical Device Regulation Update
Brazil’s health authority Anvisa has launched its national UDI system, Siud, marking a major step toward global alignment in medical device traceability. Starting July 2025, manufacturers must register devices in the database and apply standardized UDI labels.
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Regulatory Update
Mexico
July 7, 2025
COFEPRIS Streamlines Medical Device Registration: Key Takeaways from Articles 22 to 25 of the Official Gazette
COFEPRIS introduced sweeping reforms in June 2025 that streamline medical device registration for foreign manufacturers, including recognition of international approvals, expanded GMP documentation options, new homologation codes, and a 30-day review timeline. These changes mark a major step toward regulatory alignment with global standards and faster market access in Mexico.
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Regulatory Update
European Union
July 3, 2025
MDCG Guidance Documents Clarify Rules on Medical Device Software in the EU
Two June 2025 guidance documents from the European Commission’s Medical Device Coordination Group (MDCG) clarify how medical device software is defined, classified, and distributed in the EU. From tighter rules on intended purpose to platform obligations under the Digital Services Act, these updates crystallize compliance expectations for both manufacturers and app hosts.
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Regulatory Update
United Kingdom
July 2, 2025
UK MHRA June 2025: Major Post-Market Surveillance (PMS) Overhaul for Medical Devices
The UK MHRA’s June 2025 updates introduce sweeping changes to post-market surveillance requirements for medical devices in Great Britain, marking the first major regulatory shift since Brexit. With new PMS regulations now in force, manufacturers must urgently update surveillance systems, incident reporting protocols, and FSCA procedures to stay compliant and maintain market access.
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Regulatory Update
Malaysia
Mexico
Brazil
June 19, 2025
Weekly Regulatory News
This week in global device regulatory news, Malaysia’s MDA issued updated ASEAN guidance on borderline products and risk-based classifications, Mexico’s COFEPRIS proposed faster equivalency pathways that accept IMDRF- and MDSAP-member approvals, and Brazil’s Anvisa cancelled IVD devices that missed the RDC 830 reclassification cutoff.
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Regulatory Update
United States
Mexico
June 5, 2025
Weekly Regulatory News
Our weekly regulatory news round-up includes the US FDA's debut of “Elsa,” an agency-wide generative-AI platform to speed reviews and boost efficiency. In addition, Mexico’s COFEPRIS announced sweeping Plan Mexico reforms aimed at digitizing procedures, reclassifying 2,200 devices, and slashing clinical-protocol review times in a bid to become a WHO-listed authority.
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Regulatory Update
Singapore
Brazil
May 30, 2025
Weekly Regulatory News
This week in global device regulatory news, Singapore’s HSA kicked off a pilot Change Management Program for SaMD, began Phase 2 UDI labelling for Class D devices, and issued joint clinical-trial principles for machine-learning devices with Korea; Brazil’s Anvisa published a draft user manual for its forthcoming UDI database; and Turkey’s TITCK mandated six-month supply-interruption notices while tightening ÜTS registration for IVDs re-classified under the IVDR.
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Regulatory Update
Brazil
China
United Kingdom
Switzerland
European Union
May 22, 2025
Weekly Regulatory News
This week in global device regulatory news, Team-NB issued a position paper on how the EU AI Act meshes with MDR/IVDR, the UK MHRA refreshed its MORE guidance ahead of new post-market-surveillance rules, Swissmedic adopted the EU’s MIR Form v7.3.1 for serious-incident reporting, Brazil’s Anvisa opened a consultation on single-use device processing practices, and China’s NMPA updated its catalogue of devices exempt from clinical evaluation.
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Regulatory Update
United States
Brazil
May 14, 2025
Weekly Regulatory News
This week in global device regulatory news, the US FDA unveiled plans for unannounced inspections at foreign device manufacturing sites, and Brazil’s Anvisa opened a targeted consultation on a new device framework while setting phased dates to integrate health‑surveillance fee payments into its foreign‑trade portal.
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Regulatory Update
European Union
China
Switzerland
May 8, 2025
Weekly Regulatory News
This week in global device regulatory news, the European Commission rolled out MIR Form v7.3.1 for MDR/IVDR incident reporting, Switzerland advanced streamlined review for FDA-cleared devices, Peru created the autonomous Apemed authority to replace Digemid, and China issued new quality standards for online medical‑device sales and released registration‑review guidelines for ten products.
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Regulatory Update
United States
Brazil
May 2, 2025
Weekly Regulatory News
This week in medical device regulatory news, the FDA launched ESG NextGen, a modernized platform for secure electronic submissions that replaces the legacy WebTrader system; and Brazil’s Anvisa reclassified ultrasensitive CRP devices from Risk Class III to Class II, simplifying the regulatory pathway from registration to notification.
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Regulatory Update
Saudi Arabia
European Union
April 16, 2025
Weekly Regulatory News
This week in global device regulatory news, SFDA has introduced major changes to GHTF MDMA license renewal and update requirements and the European Union has updated harmonised standards for medical gloves, device sterilization, and ambulance equipment.
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Regulatory Update
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April 9, 2025
Weekly Regulatory News
New Australian UDI regulations are now in effect, the impact of the revised EU REP symbol on medical device labeling in the European Union, Mexico's COFEPRIS has announced modifications to GMP requirements, and more in this week's global medical device regulatory updates.
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Regulatory Update
Mexico
Brazil
China
European Union
April 3, 2025
Weekly Regulatory News
Mexico's COFEPRIS introduced new guidelines for compliance with GMP requirements, the EU reclassified SARS-CoV-2 testing devices, China NMPA issued new guidelines and requirements for medical device inspections, and more in this week's global medical device regulatory update.
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Regulatory Update
European Union
Brazil
China
March 26, 2025
Weekly Regulatory News
This week in medical device regulatory news, the European Commission has updated official guidance on the classification of IVDs under the IVDR; Brazil has opened public consultation on UDI database management and suspended electronic signature requirements; and China revised its regulations on domestic production of imported medical devices.
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Regulatory Update
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March 20, 2025
Weekly Regulatory News
In this week's regulatory update, we bring you news from Brazil and China, including new guidelines for medical device clinical trial inspections from China's NMPA and the availability of medical device price monitoring data on ANVISA's Business Intelligence dashboards.
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Regulatory Update
European Union
Brazil
March 12, 2025
Weekly Regulatory News
This week's round up of medical device regulatory news covers digital advancements, including the official publication of the Regulation on the European Health Data Space (EHDS) in the EU and the introduction of Avisalegis, a subscription-based notification service that alerts users about new regulatory publications in Brazil.
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Regulatory Update
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February 19, 2025
Weekly Regulatory News
This week in global medical device news: Brazil's ANVISA goes 100% digital, more Approved Bodies in the UK, revised guidance on HIV self-test kits in Malaysia, and more.
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Regulatory Update
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February 12, 2025
Weekly Regulatory News
The fifth revision to the EU's guidance on Notified Body requirements under the MDR and IVDR has been released. Canada published new guidance on machine learning-enabled devices, findings from China's Medical Device Standards Management Annual Report, and more in this week's round-up of medical device regulatory news.
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Regulatory Update
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February 5, 2025
Weekly Regulatory News
To close out January 2025, we are reporting on medical device regulatory developments in the European Union and Switzerland, including IVDR compliance challenges cited in the MedTech Europe 2024 Regulatory Survey, as well as guidance, FAQ, and form updates from Swissmedic.
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Regulatory Update
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January 29, 2025
Weekly Regulatory News
Wrapping up January 2025, medical device regulatory developments include new forms for NBs in Europe, new PMS guidance in the UK, an expedited approval partnership between China and Malaysia, and warnings of supply chain disruptions for pediatric patients in the US.
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Regulatory Update
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January 23, 2025
Weekly Regulatory News
Medical device regulatory developments from the US and Thailand include: final FDA guidance on modular review for premarket approval applications and humanitarian device exemptions, and new expedited regulatory routes for low-risk devices and chronic disease prevention devices in Thailand.
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Regulatory Update
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January 16, 2025
Weekly Regulatory News
This week, we are reporting on medical device regulatory updates from Canada, Europe, Brazil, and China. China's NMPA released registration review timelines, clarification on MDR and IVDR vigilance terms is now available, and Health Canada updated validation rules for non-eCTD transactions.
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Regulatory Update
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January 8, 2025
Regulatory Insights – December 2024 to January 2025: Key Updates from Europe and the US
To kick off 2025, we bring you a round up of medical device regulatory updates from across Europe and the US, including a new position paper from TEAM-NB on MDR certification processes and numerous guidance updates from the US FDA.
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Regulatory Update
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December 18, 2024
Weekly Regulatory news
Closing out 2024, we bring you substantial medical device updates from Europe, Brazil, and beyond, including the launch of public consultation on EU device regulations, an updated roadmap for regulatory implementations in the UK, and several new and updated resolutions in Brazil.
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Regulatory Update
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December 11, 2024
Weekly Regulatory news
Early December 2024 regulatory news brings updates from Europe, US, Brazil, China, and Japan, including new FDA guidance on change controls for AI-enabled devices and an innovation-focused approach to clinical research regulations in Brazil.
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Regulatory Update
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December 4, 2024
Regulatory Insights – November 2024: Key Updates from Europe and the US
An extensive round-up of medical device regulatory news from November 2024 includes new and updated guidance documents, Q&As, and directives from Europe and the US, including the new EU Product Liability Directive for AI and Smart Products.
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Regulatory Update
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November 20, 2024
Weekly Regulatory News
This week in medical device regulatory news, Thailand has introduced new refer and transfer guidelines, Europe released an updated Q&A on IVDR and MDR vigilance terms, and Romania has new rules for Economic Operators.
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Regulatory Update
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November 13, 2024
Weekly Regulatory News
This week, we bring you medical device regulatory update coverage from around the world, including new registration Q&A resources in Taiwan and Japan, UK relaunches ILAP pathway, Mexico will apply a new acquisition model, and more.
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Regulatory Update
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November 6, 2024
Weekly Regulatory News
This week in medical device regulatory news, EU parliament moves toward a revision of the EU MDR, the UK enhances post-market surveillance requirements, US FDA prioritizes guidance revisions for 2025, and more.
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Regulatory Update
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October 30, 2024
Weekly Regulatory News
Peru joins IMDRF, updated clinical trial guidance in Denmark, Romania implements new compliance requirements for professionals users, and more in this week's medical device regulatory update.
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Regulatory Update
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October 23, 2024
Weekly Regulatory News
This week in medical device regulatory news: updated guidance on MDR requirements for legacy devices, China released new product guidelines, revised UK guidance on Conditional Marketing Authorizations, and more.
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Regulatory Update
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October 14, 2024
Weekly Regulatory News
This week in medical device regulatory news: Brazil expedites registration of IVDs for mosquito-born diseases; new US FDA guidance on endosseous dental implants and abutments.
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Regulatory Update
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October 9, 2024
Weekly Regulatory News
Our first round-up of October 2024 medical device regulatory updates includes new CLSI guidelines and an upcoming webinar in the US, new MDCG guidance documents in Europe, and new industry standards from the NMPA in China.
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Regulatory Update
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October 1, 2024
Weekly Regulatory News
End of September 2024 brought updates from major markets: EU IVDR transition guidance for Class D IVDs, biocompatibility guidance from the US FDA, IVD family grouping regulations from Brazil, and more.
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Regulatory Update
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September 24, 2024
Weekly Regulatory News
Medical device regulatory news from the Americas includes enhanced safety and performance standards in Brazil; new device classifications from the US FDA; and a policy for classifying combination products in Canada.
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Regulatory Update
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September 17, 2024
Weekly Regulatory News
This week, we cover more ANVISA updates from Brazil, including new labeling requirements for certain devices and a clear path for registration transfers, along with new appraisal requirements for high-risk devices in Vietnam.
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Regulatory Update
Colombia
September 10, 2024
Weekly Regulatory News
September 2024 brings several medical device regulatory developments in Singapore, new ASEAN classification guidance in Malaysia, imminent UDI implementation in Colombia, and more.
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Regulatory Update
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September 4, 2024
Weekly Regulatory News
A summary of July and August 2024 medical device and IVD regulatory developments, including insights on the IVDR transition extension, Eudamed and Swissdamed module roll outs, and more.
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Regulatory Update
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August 13, 2024
Weekly Regulatory News
Starting August 2024, the Agency will process requests via RIMS, expand consultations for China's med device industry, and launch an NPRA pilot project.
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Regulatory Update
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August 5, 2024
Weekly Regulatory News
Health Canada updates device standards: new version recognition, 6 new, 12 updated. Temporary inspections start July 1, 2024. Consultation: July 25 - Sep 23, 2024. Stay informed!
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News
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July 25, 2024
AI For Cross Border Regulation
In this episode, Medtech Insight senior reporter Hannah Daniel interviews DJ Fang, COO and co-founder of Pure Global. Pure Global employs AI to assist device manufacturers in navigating global regulations. Their discussion covers clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on certain Chinese-made medical devices.
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Regulatory Update
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July 21, 2024
Weekly Regulatory News
NMPA fosters medical device innovation through regulatory consultations, tailored plans, guidance, updates on approvals, and compliance with MDR, IVDR, and MPDG.
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Regulatory Update
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July 19, 2024
Guide to Requirements for Transfer of Rights to Medical devices in Mexico - COFEPRIS
COFEPRIS regulates the transfer of rights to ensure legal and technical compliance for medicines, medical devices, and biological products. Requirements include an application format, proof of payment, legal documentation, and a notice of operation. Transfers must be transparent, with continuous monitoring. Modifications now resolve within 24 hours instead of 3 months.
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Regulatory Update
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July 16, 2024
Weekly Regulatory News
The Clinical Trials Coordination Group (CTCG) published a Q&A for clinical trial sponsors on safety reporting. Highlights include active RFI monitoring, immutable annual reports, and CTIS transition guidelines.
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Regulatory Update
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July 3, 2024
Pure Global's Global Regulation Updates June
Recent global regulatory updates include changes for software-based medical devices, prescription lenses, and microbial, recombinant, or animal substances. Effective June 15 and July 1, 2024, with reclassification by July 1, 2026. High-risk devices have limited audits; spectacle lenses are ARTG exempt from June 15.
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Regulatory Update
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June 4, 2024
Pure Global EU Regulation Updates May
In May 2024, major regulatory updates were announced across the UK, EU and Switzerland to enhance medical and in vitro diagnostic devices. The COMBINE project was launched to streamline regulations, and new standards and frameworks were proposed to improve safety, compliance, and timely access to innovative treatments.
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Regulatory Update
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May 2, 2024
Pure Global EU Regulation Updates April
Keep up to date on the most recent developments in the EU regulatory landscape for the medical device sector. Explore our thorough overview of recent updates, encompassing fresh standards, legislative measures, and advisory materials. Delve into the details now to ensure compliance.
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Regulatory Update
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April 5, 2024
March EU Regulation Updates
Stay updated with the latest EU regulations and guidance in the medical device industry. Check out our comprehensive summary of key updates including new standards, legislative acts, and guidance documents. Dive in now to stay compliant and informed!
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Successful Case
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March 1, 2024
Pure Global earns 2 New Brazilian certificates
Pure Global Secures Two Class II Medical Device Certificates in Brazil, Bolstering International Expansion Capabilities.
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