APAC Regulatory Consulting & Submission Support | IQVIA MedTech

Strategic APAC medical device registration and global market entry solutions

Support growth across APAC and global markets with tailored regulatory strategies. Whether pursuing marketing authorization in APAC or expanding from APAC into the U.S., Europe, and beyond, IQVIA MedTech provides the guidance and execution support needed to streamline approvals and accelerate market entry.
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Unlock international growth with specialized APAC regulatory consulting

With more than 10 years of experience supporting manufacturers entering and expanding across Asia-Pacific markets, IQVIA MedTech helps MedTech and IVD companies navigate complex regulatory requirements and accelerate market access. Our regional experts combine local knowledge with global regulatory expertise to develop efficient market entry and expansion strategies across APAC.

  • Local, bilingual teams across key APAC markets providing cultural and language fluency for clearer communication and faster execution
  • Country-specific regulatory strategies tailored to requirements in Japan, China, South Korea, Singapore, Australia, and other APAC jurisdictions
  • End-to-end regulatory support spanning market assessments, submission preparation, agency interactions, and marketing authorization
  • Inbound and outbound market access expertise helping global companies enter APAC markets and APAC innovators expand internationally
Japan Market Access: Shonin & DMAH Services
End-to-end strategy, PMDA/MHLW consultations, Shonin application drafting, and Designated Marketing Authorization Holder (DMAH) services to secure compliant entry into Japan.

Japan Market Access: Shonin & DMAH Services

China, Australia & Southeast Asia Registration Pathways

Tailored medical device registration support across APAC, including China NMPA technical review management, Australian TGA registration strategy, local clinical trial/evaluation requirements, type testing, and Singaporean HSA submissions.

China, Australia & Southeast Asia Registration Pathways

ASEAN CSDT & Southeast Asia Market Access
Harmonized dossier preparation using the ASEAN Common Submission Dossier Template (CSDT) to accelerate multi-country filings across APAC jurisdictions.

ASEAN CSDT & Southeast Asia Market Access

In-Country Authorized Representation & License Management
Independent local license holder services, In-Country Caretaker representation, and post-market license transfer support to protect your intellectual property and commercial flexibility.

In-Country Authorized Representation & License Management

Global Dossier Architecture & Expedited Pathways
Cross-border lifecycle planning and medical device submission support designed to leverage regional innovation pathways to streamline multi-region filings.

Global Dossier Architecture & Expedited Pathways

Global medical device regulatory services

We build and execute tailored strategies to meet rigid international market demands across the entire product lifecycle.

Technology-enabled regulatory management across APAC markets

Modernize traditional medical device market access consulting with IQVIA MedTech's robust data and technology ecosystem. We combine regional regulatory intelligence with scalable software platforms to support continuous authorization across global markets.

Our proven track record

2,000+

CLIENTS LEVERAGED MEDTECH GLOBAL REGULATORY SERVICES

200+

GLOBAL MEDTECH REGULATORY SUBMISSIONS PER YEAR

11

EXPERTISE HUBS FOR MEDTECH ACROSS APAC

A deep therapeutic & scientific bench across specialized clinical domains

The IQVIA MedTech team features former regulatory agency officials, biostatisticians, clinicians, medical writers, and biomedical engineers with specialization in an array of high-intent MedTech therapeutic areas:

  • Cardiovascular
  • Neurology
  • General Surgery
  • Orthopedics, Spine & Musculoskeletal
  • Metabolic, Endocrine & Gastrointestinal
  • In Vitro Diagnostics
  • Digital Health
  • And more
MCRA is now part of IQVIA MedTech
Your Strategic Partner in Regulatory Success
IQVIA MedTech and MCRA bring together regulatory expertise with advanced analytics, technology, and global reach. Whether you're preparing for FDA submission, EU MDR certification, or global market entry, our integrated team provides the strategic guidance and operational support to move your product forward.
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Interactive Case Study

Gaining Japanese regulatory approval & rare new reimbursement category for PROCEPT BioRobotics

THERAPY
 Robotics


SERVICES
 Japanese Regulatory and Reimbursement

PROCEPT BioRobotics is a San Jose, CA-based medical robotics company focused on urology. It develops and sells image-guided surgical robotic systems for minimally invasive urologic procedures, especially for benign prostatic hyperplasia (BPH). They engaged MCRA with assistance in Japanese Regulatory Approval and Reimbursement Services for their Aquablation therapy.
Challenge

Establishing reimbursement for U.S. MedTech in Japan is no small feat — it requires deep regulatory insight, strategic alignment, and an unwavering focus on patient value.
MCRA Japan was honored to assist in bringing this innovative technology to a market known for early adoption and a strong commitment to patient outcomes.
Solution

MCRA Japan helped PROCEPT BioRobotics achieve both regulatory approval and a rare new reimbursement category listing for their Aquabeam Robotic System. This category is designated for products that bring unique benefits to patients, healthcare providers, and the overall Japan healthcare system.

“We view Japan as a very promising market for the adoption of Aquablation therapy, which has a long history of adopting new, innovative technologies, while prioritizing patient outcomes.”

— Barry Templin, Senior Vice President of Medical Affairs and Market Access at PROCEPT BioRobotics

Results

  • MCRA Japan’s Regulatory and Reimbursement teams played a critical role assisting PROCEPT BioRobotics in gaining regulatory approval in Japan and establishing a new Category Reimbursement Listing Code.
  • MCRA’s integrated expertise and regional acumen ensured smooth navigation of Japan’s complex reimbursement process, giving Japanese patients access to a safe, effective, leading-edge urologic therapy.

“We are very thankful to the entire MCRA Japan organization for guiding us through the process of establishing reimbursement in Japan.”

— Barry Templin, Senior Vice President of Medical Affairs and Market Access at PROCEPT BioRobotics

Frequently asked questions about global and APAC regulatory consulting

IQVIA MedTech helps manufacturers navigate regulatory requirements across key APAC markets with localized expertise, bilingual support, and country-specific regulatory strategies. Our teams provide guidance on market entry planning, submission preparation, agency interactions, and commercialization readiness, helping companies accelerate approvals and market access while addressing the unique requirements of each jurisdiction.
Yes. We develop harmonized global regulatory strategies that leverage common technical documentation across multiple target markets. By identifying overlapping regulatory requirements and aligning submission plans early, we help manufacturers streamline dossier preparation, reduce duplication, and support more efficient regulatory pathways across international markets.
Regulatory approval is only one step toward commercial success. Reimbursement pathways, health technology assessments (HTAs), clinical evidence expectations, and procurement requirements can vary significantly between markets. Aligning regulatory, clinical, and commercial strategies early helps ensure evidence generation supports both market authorization and successful adoption in target countries.
Expand your medical device reach with proven global regulatory experts
Partner with IQVIA MedTech to navigate international registration pathways, execute seamless filings, and achieve successful market entry worldwide.
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