Background

The client, a U.S.-based leader in ophthalmic optics, engaged Syrma Johari MedTech to obtain multi-country regulatory approvals for their Class A, U.S. FDA-approved ophthalmic assisting device. To expand product reach across multiple international markets, the client sought a partner capable of efficiently coordinating global regulatory submissions within tight timelines. Syrma Johari MedTech’s vast expertise in medical device Quality Assurance and Regulatory Affairs (QARA) uniquely positioned us to deliver an end-to-end solution to navigate this complex regulatory journey.

Objectives

• Obtain regulatory approvals for the client’s ophthalmic assisting device across major Asia-Pacific markets (Singapore, Thailand, Malaysia, the Philippines, Sri Lanka, Taiwan, and Indonesia), as part of a broader plan to reach over 80 international markets
• Streamline and align the registration process in compliance with diverse regional regulatory frameworks within short project timelines

Business Challenge

Regulatory & Compliance Challenges

• Variability in country-specific regulations with overlapping submission schedules, requiring efficient planning, customized submissions, and tracking mechanisms for each target market
• Close coordination required between the client, our internal RA team, and multiple Local Authorized Representatives (LARs) to avoid delays
• Need for alignment of technical documentation with local regulatory formats while maintaining consistency with the client’s internal templates

Our Approach

A well-structured regulatory plan was developed to address the identified challenges while considering the unique characteristics of the device. Our multidisciplinary team of regulatory experts supported the client across all key phases.

Product Understanding & Gap Analysis

• Determined the device’s risk classification.
• Conducted a documentation gap analysis to align existing technical files with regional regulatory expectations.

Regulatory Strategy Development

• Identified the appropriate regulatory pathways based on device classification, risk profile, and target markets.
• Developed a regulatory roadmap and submission framework outlining country-specific requirements, submission formats, timelines, milestones, and stakeholder roles.

Documentation Preparation & Compilation

• Prepared and compiled complete technical documentation, including Design History Files (DHFs), risk management files, biocompatibility records, Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) reports, labeling and packaging documentation, Device Master Records (DMRs), and Quality Management System (QMS) documents.

Country-Specific Dossier Submissions

• Managed dossier submissions in compliance with regulatory requirements for each region.
• Coordinated with internal teams and regional LARs to ensure documentation accuracy and fast-track approvals.
• Achieved an average turnaround time of 6–8 weeks for dossier preparation and submission per country.

Query & Deficiency Response Support

• Provided support for query and deficiency management, authority liaison, and response submission to ensure timely approvals.

Results & Business Impact

Measurable Outcomes

• 80+ international markets covered under global regulatory submissions support
• 6–8 weeks average time taken for dossier preparation and submission per country
• 100% documentation packages submitted as per regional regulatory timelines

Operational & Market Impact

• Supporting registrations across key Asia-Pacific markets — Singapore, Thailand, Malaysia, the Philippines, Sri Lanka, Taiwan, and Indonesia.
• Enabled shorter time-to-market through structured planning, real-time tracking, and proactive communication with regional LARs.
• Established a consistent framework to support ongoing registrations as part of the broader regulatory submission program across 80+ countries worldwide.

Key Impact Metrics

• 80+ international markets covered under global regulatory submissions support
• 6–8 weeks average time taken for dossier preparation and submission per country
• 100% documentation packages submitted as per regional regulatory timelines

Streamline Your Global Regulatory Submissions

Contact us to navigate complex global regulatory frameworks and accelerate your medical device go-to-market strategy.