Global Harmonization in 2025: How Reliance Pathways Are Transforming Medical Device Regulation

Medical device regulation has long been criticized as fragmented and duplicative. A manufacturer seeking approval in multiple countries often had to prepare different dossiers, undergo multiple audits, and meet varying standards. This approach added cost, delayed innovation, and sometimes kept life-saving technologies from reaching patients quickly.

In recent years, regulators have responded by pursuing harmonization and reliance pathways. These initiatives are designed to reduce duplication and increase efficiency, enabling countries to leverage the regulatory work already done by trusted authorities. In 2025, harmonization is no longer a theoretical aspiration. It is reshaping how companies plan regulatory strategies and how quickly devices can reach patients worldwide.

This blog will explore the key harmonization initiatives driving change, their benefits and limitations, and the practical steps companies should take to capitalize on these opportunities.

What is Harmonization and Reliance?

• Harmonization refers to aligning regulatory requirements and standards across jurisdictions. For example, the FDA’s adoption of ISO 13485 in its new Quality Management System Regulation (QMSR) is a major harmonization step.

  
  

• Reliance means one regulator accepts or builds upon the assessment of another. For example, a country might accept a CE certificate or FDA approval as part of its own market authorization process.

  
  

Together, these approaches allow regulators to share work, reduce redundancy, and focus resources on higher-risk products.

Key Initiatives Driving Global Harmonization

FDA’s QMSR Alignment with ISO 13485

The FDA’s finalization of the QMSR, effective February 2026, aligns U.S. quality system requirements with ISO 13485. This reduces differences between U.S. and international quality expectations, making it easier for manufacturers to maintain one global QMS. It also supports global reliance initiatives such as the Medical Device Single Audit Program (MDSAP).

Medical Device Single Audit Program (MDSAP)

MDSAP allows a single audit, conducted by an authorized auditing organization, to satisfy regulatory requirements in the U.S., Canada, Australia, Brazil, and Japan. The program now covers roughly 60 percent of the global medtech market. MDSAP adoption is expanding as more regulators evaluate joining or recognizing it. For manufacturers, MDSAP reduces audit fatigue and increases efficiency, though it also requires robust systems that can withstand detailed multi-jurisdictional review.

International Medical Device Regulators Forum (IMDRF)

IMDRF has developed common frameworks for clinical evaluation, adverse event reporting, and software as a medical device. Many regulators, including FDA and EU authorities, base their requirements on IMDRF documents. For example, the IMDRF’s work on unique device identification (UDI) has been adopted globally, with the U.S., EU, China, and Brazil implementing similar systems.

UK International Recognition Framework

Post-Brexit, the UK has moved toward recognizing approvals from trusted regulators, including FDA and EU CE certificates. This reduces duplication and supports faster access to the UK market. While details are still evolving, the policy signals the UK’s intent to be a globally connected regulatory hub.

Regional Reliance Pathways

Several regions are creating reliance frameworks:

• ASEAN countries are developing common technical requirements and exploring reliance on major regulators.

  
  

• Middle East authorities increasingly accept CE or FDA approvals for faster access.

  
  

• Latin America: Brazil’s ANVISA and Mexico’s COFEPRIS are moving toward mutual reliance and stronger alignment with IMDRF.

  
  

Benefits of Harmonization and Reliance

1. Faster Market Access: Leveraging approvals from trusted regulators can shorten time to market, allowing patients to access innovations sooner.

   
   

2. Reduced Costs: Preparing one core dossier and undergoing fewer audits reduces resource demands on regulatory teams.

   
   

3. Consistency: A harmonized approach ensures quality systems and documentation are consistent across markets, reducing confusion.

   
   

4. Global Strategy: Companies can plan launches globally rather than sequentially, capturing opportunities in multiple markets more efficiently.

   
   

Challenges and Limitations

Despite progress, harmonization is not yet complete. Challenges include:

• Different Legal Frameworks: Each country has its own laws, which limit how far reliance can go. For example, the FDA cannot automatically accept a CE mark, and the EU does not automatically recognize FDA approvals.

  
  

• Variable Implementation: While MDSAP is accepted by multiple regulators, each country interprets and uses the reports differently.

  
  

• Notified Body Capacity in Europe: Even with harmonization, bottlenecks in Notified Body availability under MDR and IVDR remain.

  
  

• Emerging Market Nuances: Some markets still require local representation, language translations, or additional testing, even if they accept reliance on global approvals.

  
  

Practical Steps for Manufacturers

1. Develop a Global Core Dossier: Prepare technical documentation aligned with IMDRF standards that can be adapted to different markets with minimal changes.

   
   

2. Consider MDSAP Certification: If you sell into multiple major markets, MDSAP certification may streamline audits and reduce inspection risk.

   
   

3. Leverage FDA or CE Approvals: Use existing approvals strategically to accelerate entry into markets that recognize them. Maintain awareness of which countries accept reliance pathways.

   
   

4. Monitor Harmonization Developments: Regulatory landscapes evolve quickly. Assign responsibility for tracking new reliance agreements and guidance.

   
   

5. Coordinate Quality Systems: Align your QMS with ISO 13485 and ensure it addresses regional differences, such as FDA reporting requirements or EU vigilance.

   
   

Case Example

A mid-sized orthopedic company recently pursued MDSAP certification. Although the audit was more rigorous than its previous ISO 13485 audits, the payoff was significant: the MDSAP certificate was accepted in Canada, Australia, and Brazil, and recognized by FDA.

As a result, the company reduced inspection disruptions, consolidated documentation, and launched products in three markets simultaneously.

Another firm entering the UK market leveraged its existing CE certificates under the UK’s recognition framework. This eliminated the need for a separate UKCA approval process, saving months of effort and allowing the product to launch before a competitor that had not taken advantage of the policy.

Strategic Implications for Executives

For CEOs and boards, harmonization is not just a compliance issue, it is a growth strategy. Companies that understand and leverage reliance pathways can accelerate global revenue and reduce costs.

For VPs of QA/RA, harmonization requires building systems that meet the highest common denominator of requirements. It also means staying ahead of evolving policies and ensuring submissions are structured for global reuse.

For product leaders, harmonization opens opportunities to launch products in multiple regions more quickly, but it also requires coordination across teams to ensure marketing, labeling, and support align globally.

Conclusion

Global harmonization and reliance pathways are transforming medical device regulation in 2025. While challenges remain, the direction is clear: regulators want to reduce duplication and enable faster access to safe, effective devices. Companies that adapt will not only stay compliant but also gain competitive advantage.

How PRP Compliance Can Help: We help manufacturers design global submission strategies, prepare core dossiers, and navigate MDSAP and reliance pathways. Our experts ensure your quality systems and documentation align with international expectations, enabling faster, smoother market access. Contact PRP Compliance to maximize the benefits of harmonization for your business.