IMDRF Regulatory Reliance & Global Medical Device Harmonization: 2026 Guide

What Is Regulatory Reliance and Why Does It Matter Now?

Bringing a medical device to market in a single country is complex. Bringing that same device to 10, 20, or 50 countries — each with its own regulatory authority, classification system, documentation requirements, and review timelines — has historically meant repeating essentially the same work dozens of times. A manufacturer reported reducing their global approval timeline from 18 months to 8 months during COVID-19 by leveraging reliance pathways. That efficiency gain is now becoming available as a standard regulatory strategy, not just an emergency measure.

Regulatory reliance is the practice where one regulatory authority (RA) considers the assessments, decisions, or inspections conducted by another RA — called a "reference authority" — when making its own regulatory decisions. Rather than conducting a full independent review from scratch, the relying authority uses the reference authority's work as a foundation, supplementing it with local requirements as needed.

This is distinct from two related concepts:

In February 2026, the International Medical Device Regulators Forum (IMDRF) published the Playbook for Medical Device Regulatory Reliance Programs — a landmark guidance document that provides a practical framework for regulatory authorities worldwide to develop, implement, and strengthen reliance approaches. This playbook is reshaping how manufacturers think about global market access.

The IMDRF Reliance Playbook (February 2026)

The IMDRF Playbook (IMDRF/GRRP WG/N89 FINAL: 2026) was published in February 2026 and presented at the 29th IMDRF conference hosted by Singapore's Health Sciences Authority (HSA) in March 2026. It represents a consensus framework developed by regulatory authorities from the US (FDA), EU, Japan (PMDA/MHLW), Canada (Health Canada), Australia (TGA), Brazil (ANVISA), China (NMPA), South Korea (MFDS), Singapore (HSA), UK (MHRA), and Russia (Roszdravnadzor).

What the Playbook Covers

The playbook is not a binding regulation — it is a guidance framework that regulatory authorities can adopt and adapt. It covers:

1. Definitions and terminology: Establishing a shared vocabulary for reliance, recognition, and work-sharing
2. Types of regulatory reliance: From unilateral recognition of another authority's decisions to mutual recognition agreements and work-sharing programs
3. Building blocks for reliance programs: Including legal frameworks, trust-building mechanisms, information sharing, and transparency requirements
4. Lifecycle coverage: The playbook addresses reliance across the entire device lifecycle — premarket review, quality management system audits, post-market surveillance, and enforcement actions
5. Practical implementation guidance: Including how to establish reference authority criteria, how to handle differences between reference and local requirements, and how to manage change notifications

Types of Regulatory Reliance

The playbook describes several models that regulatory authorities can use:

Why This Matters for Manufacturers

The playbook's publication signals that reliance is moving from an ad-hoc practice used by a few progressive regulators to a globally endorsed strategic framework. For manufacturers, this means:

• Faster multi-market access: If your device is approved by a recognized reference authority (especially FDA, EU Notified Body, or PMDA), an increasing number of countries will offer expedited or abbreviated review pathways
• Reduced duplication: A single well-prepared technical file can serve as the basis for submissions across multiple reliance-based markets
• Lower costs: Less duplication means fewer unique submissions, less country-specific testing, and fewer local regulatory consultants
• Strategic sequencing: Obtaining clearance from a widely recognized reference authority first (typically FDA or CE marking) can unlock faster access to 10–20 additional markets through reliance pathways

MDSAP: The Most Established Reliance Program

The Medical Device Single Audit Program (MDSAP) is the most mature and widely adopted regulatory reliance program in the world. Under MDSAP, a single quality management system audit conducted by an authorized auditing organization satisfies the QMS requirements of all participating regulatory authorities.

Current MDSAP Participating Authorities (2026)

2026 MDSAP Developments

FDA chairs the MDSAP Regulatory Authority Council (RAC) for the 2026–2027 term. In this capacity, the FDA has signaled its intent to expand MDSAP participation in Asia — a region where medical device markets are growing rapidly but where manufacturers often face fragmented regulatory requirements.

The FDA's 2025 International Harmonization Annual Assessment Report highlighted MDSAP as a key harmonization initiative. In 2025, the FDA issued 54 guidance documents and continued to use MDSAP audits as a primary mechanism for ensuring quality system compliance among international manufacturers.

Malaysia's September 2025 entry into MDSAP was a significant development. Malaysia's Medical Device Authority (MDA) now accepts MDSAP audit reports, which means manufacturers already in the MDSAP program can use their existing audit results to support Malaysian market access without a separate quality system inspection.

How Manufacturers Should Use MDSAP Strategically

1. Participate proactively: Even though MDSAP is mandatory only in Canada, voluntary participation provides audit coverage across 5–6 regulatory jurisdictions simultaneously
2. Use MDSAP to support QMSR compliance: The new FDA QMSR (effective February 2, 2026) aligns with ISO 13485, which is the standard audited under MDSAP. An MDSAP audit that covers FDA requirements is now directly aligned with QMSR expectations
3. Leverage for new market entry: When entering a new market (particularly Malaysia, Brazil, or South Korea), an existing MDSAP audit report can significantly streamline the quality system compliance component of your registration
4. Align audit timing with registration timelines: Schedule your MDSAP audit cycle to provide fresh audit reports when you anticipate filing registrations in new markets

Regional Reliance Programs and Developments

ASEAN Single Submission Framework

At the MDA annual address in early 2026, Malaysia proposed an ASEAN framework for a single submission accepted by four countries: Malaysia, Singapore, Thailand, and Indonesia. This would represent the most ambitious regulatory reliance initiative in Southeast Asia.

Currently, ASEAN medical device regulation is guided by the ASEAN Medical Device Directive (AMDD) and the Common Submission Dossier Template (CSDT), but actual implementation varies significantly by country. A single submission framework would allow a manufacturer to:

• Prepare one dossier in CSDT format
• Submit to one participating authority
• Receive recognition (or abbreviated review) from the other three

Singapore–Malaysia Pilot Program: Launched in August 2025, this mutual recognition pilot allows each country to consider the other's device registration assessments. This is the most advanced bilateral reliance program in ASEAN and serves as a testing ground for the broader four-country framework.

Thailand: Auto-approval for Class 1 devices became effective in February 2025. For Class 2–4 devices, Thailand now requires CSDT format submissions and accepts reliance on reference authority assessments.

Malaysia: Beyond MDSAP participation, MDA published updated guidance in 2025–2026 expanding its verification pathway and ASEAN reliance options. Multiple guidances under the Medical Device Act 2012 have been updated, including definitions, import procedures, and handling of unregistered devices under special access exemptions.

Brazil (ANVISA) Regulatory Reliance

ANVISA has been actively promoting regulatory reliance through its AREE (Anuência Regulatória por Equivalência Estrangeira) program, established under IN 290/2024. This allows ANVISA to leverage assessments from recognized reference authorities for expedited device registration.

However, at the ABIOMED meeting in late February 2026, ANVISA noted that manufacturers were not capitalizing on AREE to the levels the agency expected. ANVISA is investigating why adoption has been lower than anticipated — suggesting that the regulatory and operational benefits may not yet be widely understood by industry.

What this means for manufacturers: If you already have FDA clearance or CE marking, explore whether your device qualifies for ANVISA's reliance pathway. The potential time savings (reducing Brazil registration from 6–12 months to a significantly shorter timeline) are substantial, but you may need to actively engage ANVISA to navigate the process.

Japan — Cabinet Order No. 362 (2025)

Japan published Cabinet Order No. 362 of 2025, which takes effect May 1, 2026. This order is expected to expand Japan's regulatory reliance capabilities, allowing PMDA to give greater consideration to assessments from other recognized regulatory authorities when reviewing device applications.

Historically, Japan's regulatory system has been largely self-contained — requiring Japanese-language documentation, Japan-specific QMS audits (Ordinance 169), and often Japan-specific clinical data. Any move toward reliance represents a significant shift and could meaningfully reduce the time and cost of Japanese market entry for devices already cleared in the US or EU.

The FDA and PMDA have been pursuing simultaneous US-Japan device development and approval, and PMDA opened a Washington D.C. office for US-Japan collaboration. PMDA also started English-language general consultations for non-Japanese startups in March 2025, with 14 cases in the first 6 months — a small but symbolically important step.

UK MHRA — Indefinite CE Marking Recognition

The UK MHRA has opened a consultation on a proposal for indefinite recognition of medical devices that comply with EU legislation. This is a dramatic reversal from the original plan for a full UK-specific regulatory framework with UKCA marking.

The practical significance is enormous: approximately 90% of devices on the Great Britain market currently possess CE marking. Indefinite CE recognition means manufacturers would not need to obtain separate UKCA certification — effectively making CE marking sufficient for UK market access permanently.

This is a pragmatic form of regulatory reliance: the UK would rely on EU Notified Body assessments rather than building a parallel UK conformity assessment infrastructure.

Australia TGA — 2026–2027 Priority Focus Areas

The TGA published its 2026–2027 priority focus areas, which include expanding regulatory reliance initiatives. Australia has been a strong proponent of reliance through MDSAP participation and its own comparable overseas regulator (COR) pathway, which provides expedited review for devices approved by the FDA, EU, Health Canada, or Japan PMDA/MHLW.

China NMPA — Emerging Reliance Signals

In 2025, the China NMPA established regulatory reliance programs with select reference authorities. While China's regulatory system remains largely independent, the signal of interest in reliance is notable for a market that has historically required fully independent reviews, Chinese-language documentation, and China-specific clinical data.

How to Build a Reliance-Based Global Registration Strategy

The Reference Authority First Approach

The most effective strategy for leveraging regulatory reliance is to obtain clearance from a widely recognized reference authority first, then use that clearance to unlock expedited pathways in reliance-based markets.

Tier 1 — Primary reference authorities (recognized by the most reliance programs):

• US FDA (510(k), De Novo, or PMA)
• EU Notified Body (CE marking under MDR/IVDR)

Tier 2 — Secondary reference authorities (recognized by specific regional programs):

• Health Canada
• Japan PMDA
• Australia TGA

Strategic Sequencing Framework

Practical Steps to Maximize Reliance Benefits

1. Maintain a single, modular technical file: Structure your technical documentation so that the core evidence package (design verification, risk management, biocompatibility, clinical evaluation) can be reused across markets with minimal adaptation. The IMDRF's Table of Contents (ToC) format and STED (Summary Technical Documentation) template are widely accepted.

2. Participate in MDSAP: Even if MDSAP is mandatory only in Canada, the investment in a single MDSAP audit cycle pays for itself when you enter Australia, Brazil, South Korea, or Malaysia without additional quality system inspections.

3. Sequence your registrations strategically: File in your reference authority market first. Do not file simultaneously in 10 countries — sequence registrations to take advantage of each clearance as a reference for the next market.

4. Track reliance pathway availability by country: Reliance programs are expanding rapidly. The pathways available in 2025 may differ significantly from those in 2027. Monitor IMDRF publications, national regulatory authority announcements, and industry association updates.

5. Engage local regulatory consultants who understand reliance: Not all regulatory consultants are aware of or experienced with reliance pathways. When evaluating market entry in a new country, specifically ask whether abbreviated or reliance-based review pathways are available for devices with your reference authority clearance.

6. Document your reference authority clearance comprehensively: When applying for registration in a reliance-based market, the quality and completeness of your reference authority clearance documentation matters. Ensure you can provide the full clearance letter, review summary, conditions of clearance, and any post-market commitments.

IMDRF AI Lifecycle Management Framework (April 2026)

In April 2026, IMDRF published the Technical Framework for Artificial Intelligence Life Cycle Management (IMDRF/AIML WG/N93). This framework extends the reliance and harmonization principles beyond traditional device regulation into AI-enabled medical devices — a rapidly growing segment with over 1,300 FDA-authorized AI-enabled devices in 2025 alone.

The framework addresses how regulatory authorities should approach:

• Algorithm validation across the AI lifecycle, including pre-market and post-market phases
• Algorithmic drift detection and monitoring requirements
• Good Machine Learning Practices (GMLP) as a harmonized international standard
• Predetermined Change Control Plans (PCCPs) that allow AI/ML devices to evolve without requiring full re-submission for each update

For manufacturers building AI-enabled medical devices, this framework signals that international convergence on AI regulation is accelerating. A device that meets the IMDRF AI framework's principles will be better positioned for multi-market access, as regulatory authorities align their AI-specific requirements around common principles rather than diverging into country-specific regimes.

The Future of Regulatory Reliance

What to Expect in 2027 and Beyond

The trajectory is clear: regulatory reliance is becoming the default model for how smaller and mid-sized regulatory authorities handle medical device regulation. Several developments to watch:

1. MDSAP expansion to more Asian markets: With FDA chairing the RAC and actively promoting expansion, expect additional Asian regulatory authorities to join or establish observer status in 2026–2027.

2. ASEAN single submission pilot: The four-country framework (Malaysia, Singapore, Thailand, Indonesia) is the most ambitious ASEAN reliance initiative to date. If successful, it could expand to include Philippines, Vietnam, and other ASEAN members.

3. Japan's increasing openness: Cabinet Order 362 and PMDA's Washington D.C. office signal a genuine strategic shift toward international regulatory collaboration. Japan remains one of the hardest markets to enter, so any streamlining has high value.

4. UK's post-Brexit reliance on EU: The proposed indefinite CE marking recognition represents one of the most significant reliance decisions globally — acknowledging that building a parallel regulatory infrastructure is less efficient than leveraging an existing one.

5. WHO Global Model Regulatory Framework (GMRF): The WHO is developing a global model regulatory framework for medical devices, including IVDs, that incorporates reliance principles. The WHO's Global Benchmarking Tool (GBT) assesses national regulatory systems and promotes capacity building — creating a foundation for more countries to participate in reliance programs.

6. Digital reliance infrastructure: As regulatory authorities invest in electronic submission systems and shared databases (such as EUDAMED in the EU), the technical infrastructure for real-time information sharing between authorities is improving. This could enable faster and more automated reliance decisions in the future.

The Bottom Line for Manufacturers

Regulatory reliance is not a niche concept for regulatory affairs specialists to debate — it is a practical business strategy that can reduce global registration timelines by 30–50%, lower multi-market entry costs by hundreds of thousands of dollars, and allow smaller companies to compete in markets that were previously accessible only to large multinationals with dedicated country-by-country regulatory teams.

The IMDRF Reliance Playbook provides the framework. MDSAP provides the quality system infrastructure. And national programs — from Singapore's abbreviated review to ANVISA's AREE to the UK's CE marking recognition — provide the specific pathways.

The manufacturers who benefit most will be those who:

• Obtain reference authority clearance (FDA or CE) as their first regulatory milestone
• Participate in MDSAP proactively, not just where mandatory
• Structure their technical documentation for reuse across markets
• Monitor and adopt reliance pathways as they become available in new markets
• Engage regulatory experts who understand reliance, not just country-specific compliance

The era of purely independent, country-by-country regulatory review is ending. The era of reliance-based global market access is beginning. Manufacturers who adapt their strategies accordingly will reach patients faster and at lower cost.