Team Elexes 
Elexes Team 
International Regulatory Services
Apart from the US, Canada, EU, and UK, we also offer regulatory services across the globe. We all would agree that the Asia-Pacific (APAC) region is the fastest-growing markets for medical devices that offer huge opportunities to medical device manufactuers.
While it is true that the market has potential, navigating through its diverse regulatory framework can become a nightmare.
At Elexes, we provide expert regulatory and quality compliance services tailored to the unique requirements of APAC countries, helping you achieve smooth and timely market access.
Our Expertise in APAC Regulatory Compliance
Our team has extensive experience supporting medical device manufacturers across key APAC markets, ensuring compliance with country-specific regulations, including submission processes, clinical evidence, labeling, and post-market requirements.
How We Help in Major APAC Markets?
Japan (PMDA Submissions)
We assist in navigating the Pharmaceutical and Medical Device Agency (PMDA) requirements for device registration. Our expertise includes guiding manufacturers through the Foreign Manufacturer Accreditation process, GCP compliance, and clinical trial requirements.
China (NMPA Approvals)
For devices entering China, we support you with the National Medical Products Administration (NMPA) requirements, including registration, clinical evaluations, local testing, and risk classification, ensuring a smooth approval process.
Singapore (HSA Approvals)
We assist with Health Sciences Authority (HSA) regulatory submissions, device classification, and product registration, ensuring compliance with Singapore’s Medical Device Regulations.
India (CDSCO Submissions)
We help you comply with the Central Drugs Standard Control Organization (CDSCO) requirements, from obtaining an Import License to preparing submissions for notified medical devices and ensuring compliance with India’s Medical Device Rules.
South Korea (MFDS Compliance)
Our team supports you in gaining approval from the Ministry of Food and Drug Safety (MFDS) and guides you through Good Manufacturing Practice (KGMP) certification, product classification, and registration.
Australia (TGA Submissions)
While technically part of the APAC region, Australia has its regulatory framework under the Therapeutic Goods Administration (TGA). We simplify your ARTG registration process and conformity assessments.
Our APAC Regulatory Services
At Elexes, we provide end-to-end solutions to guide manufacturers
through the transition to EU IVDR compliance, including:
Regulatory Strategy Development
We create tailored strategies to meet the specific regulatory requirements of your target APAC countries.
Product Classification and Registration
We determine the appropriate classification for your medical device and prepare comprehensive registration dossiers to meet local requirements.
Clinical Evidence and Performance Data
Our team helps you compile or conduct necessary clinical studies and evaluations to meet the region's diverse requirements.
Labeling and Packaging Compliance
We ensure your product labeling meets country-specific language, content, and format regulations across APAC markets.
Post-Market Surveillance
We assist with developing post-market surveillance (PMS) plans, adverse event reporting, and vigilance activities tailored to each market's guidelines.
Regulatory Liaison
We serve as your point of contact with local regulatory authorities, facilitating communication and addressing any queries to accelerate approval timelines.
Expand into the APAC Market with Confidence
At Elexes, we simplify the regulatory process, enabling you to focus on delivering innovative medical devices to patients across the APAC region. Whether entering one market or expanding into multiple countries, we ensure your compliance needs are met with precision and expertise.
Contact Us today to learn how we can help your medical device succeed in the dynamic APAC market.
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Experience Team
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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Then 256+ Global
Clients
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Clients Testimonials
Amazing Feedback Say About Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
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