Streamlined Approval Pathways for Medical Devices

Regulatory Landscape OverviewOur ServicesMarket SupportedCase Study/Blogs/Insights

Ensuring compliance in the ever-evolving global regulatory landscape is crucial for medical device manufacturers. Our comprehensive regulatory services support your journey from product development to market entry and beyond. With a deep understanding of international standards and local requirements, we help you navigate complex regulatory pathways to achieve timely approvals.

Regulatory Landscape Overview

Understanding the regulatory requirements of major markets is essential for successful product registration. Below is a detailed overview of the regulatory landscape for key markets:

RegionRegulatory BodyPrimary RequirementsUnique ChallengesTimeline for Approval*Recent Update
United StatesFDA (Food and Drug Administration)
  • Class I: Low-risk devices subject to General Controls like misbranding rules, device registration, and good manufacturing practices. Most are exempt from Premarket Notification (510(k)). Examples: bandages, handheld surgical instruments, nonelectric wheelchairs.
  • Class II: Intermediate-risk devices requiring General and Special Controls, such as special labeling, market surveillance, and performance standards. Most need Premarket Notification (510(k)). Examples: CT scanners, infusion pumps.
  • Class III: High-risk devices requiring General Controls and Premarket Approval (PMA), which demands scientific proof of safety and effectiveness. Examples: pacemakers, deep-brain stimulators.
Extensive premarket testing, rigorous review processes, and stringent post-market surveillance requirements
  • Class I: 1-3 months
  • Class II: 6-12 months
  • Class III: 12-24 months
The FDA issued the Quality Management System Regulation (QMSR) Final Rule, updating the device CGMP requirements under the Quality System (QS) regulation (21 CFR Part 820). The rule aligns with ISO 13485:2016, the international standard for medical device quality management systems.

Effective February 2, 2026, this rule aims to harmonize the FDA's CGMP framework with international regulatory standards. Until then, manufacturers must comply with the existing QS regulation.
European UnionNotified Bodies
  • Class I: Self-declaration for low-risk devices
  • Class II: CE marking via Notified Body review
  • Class III: Rigorous clinical evaluations, conformity assessments
Transition from MDD to MDR has increased documentation and clinical data requirements
  • Class I: 1-3 months
  • Class II: 6-12 months
  • Class III: 12-24 months
Phased rollout of EUDAMED (European Database on Medical Devices) from 2024 to 2027:
  • 2024 - Initial Rollout:
    • Complete MVP audit for four modules (Actor, UDI/Devices, Notified Bodies & Certificates, Market Surveillance).
    • Deliver technical documentation for M2M interaction.
    • Publish notices in the Official Journal (OJEU) and begin onboarding/training.
  • 2025 - Expansion:
    • Expand communication and onboarding for functional modules.
    • Start MVP audit for the Vigilance module and publish OJEU notice.
  • 2026 - Vigilance and Transition:
    • Mandatory use of Vigilance module.
    • Intensified onboarding and system refinement.
  • 2027 - Full Implementation:
    • End of transition periods.
    • Mandatory use of all EUDAMED modules for device registration, surveillance, and compliance.
JapanPMDA (Pharmaceuticals and Medical Devices Agency)
  • Class I: Notification only
  • Class II: Third-party certification
  • Class III: PMDA review, QMS audits, and clinical trial data (if required)
Language barriers, local clinical trial requirements, and QMS-specific audits
  • Class I: 1-3 months
  • Class II: 6-12 months
  • Class III: 12-24 months
September 12, 2024: Japan's Pharmaceutical and Medical Device System Subcommittee established a timeline for amending the Pharmaceuticals and Medical Devices Act (PMD Act) which regulates pharmaceuticals, cosmetics, in-vitro diagnostic reagents, and medical devices. Key focus area for streamlining Registration and Certification for Medical Devices include:
  • Improving post-marketing regulations for in vitro diagnostic products, especially for those detecting high-mutation viruses.
  • Expanding priority examination for Software as a Medical Device (SaMD) and reducing clinical trial requirements for low-risk SaMD.
CanadaHealth Canada
  • Class I: Notification only
  • Class II-IV: Licensing with increasing documentation and clinical data requirements as risk level increases
Limited pathways for expedited approvals and strict post-market reporting obligations
  • Class I: 1-3 months
  • Class II: 3-6 months
  • Class III: 6-12 months
July 3, 2024: Health Canada published Regulations to the Food and Drug Regulations (FDR) and Medical Device Regulations (MDR) to enhance post-market oversight of drugs and medical devices. Effective December 14, 2024, these include:
  • Expanded Recall Definition: Includes recalls ordered by the Minister of Health with specific reporting obligations.
  • Changes to Reporting Obligations: Type III (low-risk) medical device recalls no longer require reporting, aligning with international standards. Type I and II recalls must still be reported.
  • Reporting Framework: Clear timelines and detailed information for reporting voluntary recalls, such as lot numbers, affected quantities, and risk assessments.
  • Record-Keeping Obligations: Manufacturers, distributors, and importers must maintain detailed records of all recalls for verification by Health Canada.
  • Authority to Impose Terms on Medical Device Establishment Licences (MDEL): Health Canada can impose additional oversight measures for non-compliance.
  • Modernized MDEL Application: Requires submitting contact information.
  • Approved Regulatory Authorities List: Simplifies the process for drug establishment licences (DEL) with mutual recognition agreements (MRAs).
  • Exemptions for Finished Product Testing: Certain entities involved with radiopharmaceuticals or gene therapies may be exempt from testing requirements.
These changes emphasize new reporting, record-keeping, and regulatory oversight responsibilities for manufacturers, importers, and establishment licence holders.
AustraliaTGA (Therapeutic Goods Administration)
  • Class I: Self-certification
  • Class II: Certification with TGA or mutual recognition
  • Class III/IV: Detailed conformity assessment and clinical data requirements
Overlap of regulatory requirements with international standards but unique local pathways
  • Class I: 1-3 months
  • Class II: 3-6 months
  • Class III/IV: 6-12 months
Mid-2024: Regulatory updates by the TGA impact software-based devices, prescription lenses, and devices with microbial, recombinant, or animal substances. Key changes include:
  • Revised Classifications: Updated rules for animal-origin substances, excluding microbial/recombinant origins.
  • Software Devices: Extended timelines for transitioning to higher classifications.
  • Application Audits: Focused audits on high-risk devices (e.g., Class III, specific IVDs) with stricter evidence requirements.
  • Pathways: Pending updates for new Class III pathways using MDSAP + 510(k).
ChinaNMPA (National Medical Products Administration)
  • Class I: Notification and registration only.
  • Class II: Registration with the NMPA, including product testing in government-authorized laboratories.
  • Class III: Requires rigorous technical review, including clinical trials, NMPA inspections, and QMS audits.
Language barriers and stringent local clinical trial requirements.

Limited acceptance of foreign clinical data.

Frequent regulatory updates that require close monitoring.
  • Class I: 1-3 months
  • Class II: 6-12 months
  • Class III/IV: 12-24 months
 Updates to the Regulations on the Supervision and Administration of Medical Devices introduce:
  • Simplified Procedures for Low-Risk Devices: Streamlining processes for Class I devices.
  • Enhanced QMS Standards: Aligning more closely with ISO 13485:2016.
  • Revised Clinical Trial Requirements: Acceptance of certain foreign data for low-risk devices.
  • Digital Submissions: Launch of an online platform for submitting applications, tracking approvals, and maintaining post-market compliance.
KoreaMFDS (Ministry of Food and Drug Safety)
  • Class I: Notification and registration only.
  • Class II: Requires certification through third-party entities designated by MFDS.
  • Class III: MFDS review involving detailed technical documentation, clinical trial data (if necessary), and QMS audits.
Language barriers and need for Korean-specific labeling.

Limited mutual recognition of foreign clinical trial data.

Strict post-market surveillance and adverse event reporting requirements.
  • Class I: 1-3 months
  • Class II: 6-12 months
  • Class III/IV: 12-24 months
 The MFDS has implemented the following changes:
  • Enhanced Clinical Evaluation Requirements: Stricter data requirements for high-risk devices, particularly those involving AI and Software as a Medical Device (SaMD).
  • QMS Alignment: Revised Quality Management System requirements to better align with ISO 13485:2016.
  • Digital Submissions: Expanded use of an online platform for regulatory submissions and tracking approvals.
  • Post-Market Surveillance Expansion: Increased monitoring of adverse events and field safety corrective actions (FSCA).

* Timelines are approximate and can vary based on the complexity of the product, completeness of submissions, and regulatory authority review processes.

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  • Provide expert guidance on classification, registration, and approval processes.
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  • Compile and review comprehensive technical files and design dossiers.
  • Ensure alignment with ISO 13485, IEC 60601, and other relevant standards.
  • Support clinical evaluation reports (CERs) and post-market surveillance (PMS).
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  • Guiding pre-market approval and certification processes.
  • Strategic guidance on import/export documentation and customs clearance.
Post-Market Support

Post-Market Regulatory Support

  • Maintain compliance with changing regulations.
  • Handle adverse event reporting and field safety corrective actions (FSCA).
  • Manage renewals, amendments, and periodic reporting.

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Case Study/Blogs/Insights

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