Emerging Markets in 2025: Unlocking Opportunities Amid Rising Regulatory Complexity

For years, emerging markets were seen as relatively accessible expansion opportunities for medical device manufacturers. Regulations were often less complex than in the U.S. or EU, and companies could bring products to market with fewer hurdles. That landscape has shifted dramatically.

As of 2025, countries such as India, Brazil, and China are tightening requirements, aligning with international standards, and expanding oversight capacity. This creates new challenges but also opportunities for companies prepared to invest in compliance.

Emerging markets now represent some of the fastest-growing device markets globally, but success depends on understanding and adapting to evolving regulatory frameworks.

This blog explores the current state of device regulation in key emerging markets, the challenges companies face, and the strategies executives can adopt to thrive in these high-growth but increasingly regulated environments.

India: A Rapidly Expanding Regulatory Framework

India’s Central Drugs Standard Control Organization (CDSCO) has been steadily expanding medical device regulation since 2020. As of October 2023, all device classes require registration, and by 2025 India effectively regulates its entire device market.

Key developments:

• Classification System: India has adopted a risk-based classification system similar to the EU’s, from Class A (low risk) to Class D (high risk).

  
  

• Licensing: All devices require a license from CDSCO. Local authorized representatives must be designated for foreign manufacturers.

  
  

• Quality System Requirements: Manufacturers must comply with ISO 13485, and CDSCO increasingly inspects for compliance.

  
  

• Clinical Investigations: For higher-risk devices, local clinical data may be required, especially if foreign data is not deemed representative of the Indian population.

  
  

For manufacturers, India represents both a huge opportunity and a regulatory challenge. With a population of 1.4 billion and a rapidly growing healthcare system, the market is too large to ignore. However, navigating CDSCO requirements requires strong local representation and early regulatory planning.

Brazil: Strengthening ANVISA and Expanding UDI

Brazil’s National Health Surveillance Agency (ANVISA) has become one of the most sophisticated regulators in Latin America.

Key developments:

• MDSAP Enforcement: Brazil is one of the five founding members of the Medical Device Single Audit Program (MDSAP). Manufacturers selling to Brazil must hold MDSAP certification, effectively raising the bar to ISO 13485 plus specific regional requirements.

  
  

• Unique Device Identification (UDI): ANVISA is implementing UDI in alignment with IMDRF standards. Manufacturers must assign UDIs and register them in Brazil’s system.

  
  

• Increased Inspections: ANVISA has expanded inspection resources, targeting not only Brazilian manufacturers but also foreign firms supplying the market.

  
  

• Clinical Requirements: For certain high-risk devices, ANVISA requires local clinical investigations or bridging studies.

  
  

Brazil’s market, valued at more than $10 billion annually, is attractive, but compliance costs are significant. Companies unable to secure MDSAP certification or meet UDI requirements risk exclusion.

China: Simultaneous Submissions and Heightened

Oversight

China’s National Medical Products Administration (NMPA) continues to evolve rapidly. In 2024, NMPA removed the requirement that devices be approved in the country of origin before Chinese registration. This opens the door to simultaneous submissions, potentially accelerating market access.

At the same time, NMPA has tightened enforcement:

• UDI Implementation: UDI requirements are being phased in for Class III and Class II devices.

  
  

• Clinical Data: Local clinical trials or data bridging are often required, particularly for implants and diagnostics.

  
  

• Technical Standards: Devices must meet Chinese GB/YY standards, which may differ from international norms.

  
  

• Post-Market Surveillance: NMPA requires robust PMS and vigilance systems, and is increasingly conducting manufacturer inspections.

  
  

China represents both the largest opportunity outside the U.S. and EU and one of the most complex regulatory landscapes.

Other Key Markets

Middle East

Countries such as Saudi Arabia and the United Arab Emirates are aligning more closely with international standards. Saudi Arabia’s SFDA requires ISO 13485 certification and has strengthened vigilance requirements.

ASEAN Region

The ASEAN Medical Device Directive (AMDD) is being implemented across Southeast Asia, creating more consistent requirements across countries such as Malaysia, Singapore, and Thailand.

Africa

South Africa remains the most structured regulatory environment on the continent, with the South African Health Products Regulatory Authority (SAHPRA) requiring licensing and compliance with international standards. Other African nations are moving more slowly but often rely on WHO prequalification or CE/FDA recognition.

Challenges for Manufacturers

1. Regulatory Diversity: Despite convergence, each country maintains unique requirements. A one-size-fits-all approach is not feasible.

   
   

2. Local Representation: Most markets require local authorized representatives or legal entities, creating reliance on third parties.

   
   

3. Clinical Data Requirements: Demands for local data can delay market entry and increase costs.

   
   

4. Supply Chain Logistics: Customs clearance, labeling, and distribution requirements vary and can complicate operations.

   
   

5. Resource Demands: Expanding into multiple emerging markets simultaneously stretches regulatory and quality teams.

   
   

Case Examples

• Company A: A mid-sized U.S. device manufacturer underestimated India’s licensing requirements, leading to delayed market entry and lost contracts. After hiring a dedicated regulatory team and securing a reliable Indian authorized representative, the company regained momentum, but only after significant delays.

  
  

• Company B: A European diagnostics firm pursued simultaneous submissions in the U.S. and China. By leveraging NMPA’s removal of the country-of-origin approval requirement, it achieved faster Chinese market access than competitors who waited for CE marking first.

  
  

• Company C: A Brazilian subsidiary of a global firm failed to renew its MDSAP certificate on time. ANVISA halted product imports until recertification was achieved, causing costly supply disruptions.

  
  

Strategic Implications for Executives

For CEOs

Emerging markets represent growth but also risk. CEOs should ensure expansion strategies include regulatory readiness. Partnering with reliable local representatives and allocating resources to compliance is non-negotiable.

For QA/RA Leaders

Quality and regulatory leaders must build global strategies that align with IMDRF standards while tailoring to local nuances. MDSAP certification, UDI readiness, and PMS systems should be prioritized.

For Operations Leaders

Supply chain resilience is critical. Operations teams must plan for customs challenges, labeling requirements, and logistics infrastructure in new markets.

Final Thoughts

Emerging markets in 2025 are no longer easy entry points. Regulators in India, Brazil, China, and beyond are raising the bar to international standards. Success in these markets requires foresight, investment, and regulatory expertise.

How PRP Compliance Can Help: We support companies entering emerging markets by preparing global dossiers, aligning quality systems with international standards, and managing registrations with local authorities. Contact PRP Compliance to accelerate access to high-growth markets while staying compliant.