Copy to clipboard 
During the virtual Summer Series of the Orthopaedic Surgical Manufacturers Association (OSMA), industry experts provided practical tips for navigating the regulatory landscapes and understanding market entry strategies in key countries.
Philip O’Neill, CEO of the Parkdale Group, discussed the Japanese market; Dr. Viraj Vaidya, Senior Product Manager at Building bttn, and Dr. Premnath Venugopalan, Co-founder and Director of Serigen Mediproducts, covered India; and Daniel Moelands, Vice President Regulatory Affairs of APAC at J&J Medtech, provided a broader overview of the APAC region.
Here’s a breakdown of each market based on their insights and advice.
Japan
Japan represents an excellent opportunity for growth because of a rapidly aging population (30% over age 65), projected doubling of knee and hip arthroplasties by 2030 and a harmonized regulatory system where American companies already dominate the device market. The Pharmaceuticals and Medical Devices Agency (PMDA), the country’s regulatory body, has become the fastest regulator globally and serves as the reference regulator for most of Asia, making Japanese approval a gateway to the entire region.
Market Entry. Breakthrough technologies require strong backing from key opinion leaders who are willing to work with the PMDA, which frequently consults local experts when evaluating new devices. Beyond regulatory approval, successful market entry depends on working with reimbursement specialists who present new devices to the Central Social Insurance
Medical Council and demonstrate clear clinical advantages to obtain favorable reimbursement rates.
Long-term success requires establishing a local presence, including an office, staff and demonstrated dedication to the market. Relationships with physicians and other stakeholders are essential because Japanese hospitals value direct local investment and sustained engagement over distributor arrangements.
The Japan External Trade Organization (JETRO) supports companies that are pursuing market entry projects by identifying potential partners, making product introductions and connecting companies with key contacts in the corporate world. JETRO is less effective at facilitating relationships with physicians, but it remains a valuable resource for advancing business initiatives.
Regulatory Landscape. The PMDA has expanded its staff, implemented key performance indicators for review speed and is now regarded as one of the world’s fastest regulatory agencies. The agency has also served as a reference regulator for neighboring Asian countries — including Thailand, Malaysia, Vietnam, Australia and New Zealand — allowing products approved in Japan to gain accelerated access in these markets.
Approval timelines vary by device complexity. Novel implantable devices typically require about 13 months after pre-submission meetings, while “me-too” products that conform to existing ISO standards can receive expedited review.
Early engagement with the PMDA is critical, particularly for clinical data evaluation, as overseas clinical trials don’t always meet Japanese standards. A three-stage pre-meeting system with the PMDA is used to review clinical data, helping to clarify expectations and reduce the risk of costly delays.
Quality management system (QMS) compliance is another key consideration. In some regions, the Medical Device Single Audit Program (MDSAP) may be available, which reduces the burden of QMS requirements. If a QMS is not in place, PMDA officials will inspect the foreign manufacturing facility, a very expensive process that also requires a Japanese professional to review the resulting documentation.
Reimbursement is governed by the Japan Medical Device Nomenclature (JMDN), which assigns device codes, risk classes and reimbursement levels. For established me-too devices, reimbursement rates are pre-set and publicly available, allowing manufacturers to right-size revenue expectations.
Novel approved devices must be presented to the JMDN for reimbursement based on new functionality or clinical benefits. Strategies such as leveraging favorable foreign average prices and first-in-Japan approval can help secure premium reimbursement.
India
India, one of the fastest-growing healthcare markets globally, is projected to surpass $372 billion by 2025. With a population of 1.4 billion, the country presents massive demand for affordable, scalable orthopedic solutions. Success depends on several critical factors: regulatory agility, cultural intelligence, cost competitiveness, innovation and strong local partnerships.
Market Entry. Foreign companies benefit from collaboration with authorized local importers that can facilitate regulatory filings. Partnering with these importers and submitting digital regulatory submissions through India’s regulatory body, the Central Drugs Standard Control Organization (CDSCO), improves approval efficiency.
Devices already cleared by FDA or CE-marked often qualify for bridging documentation, which streamlines entry into the market. Engaging a local regulatory expert or consultant helps companies navigate regulatory filings, clinical requirements and postmarket surveillance compliance.
Local pilot studies are strongly recommended, starting in Tier One cities and trusted hospital networks. Each city typically has a few influential physicians whose endorsements significantly impact product acceptance. Early engagement with these physicians helps generate product awareness, build relationships and support adoption.
Pricing strategy is crucial in India’s price-sensitive, high-volume market. Products should be positioned at low- to mid-range price points, relying on high sales volumes and after-sales support to achieve profitability. Hospitals prioritize localized sales support; inadequate after-sales service is a common reason for failure in the market.
Regulatory Landscape. India classifies medical devices into four risk-based categories governed by the CDSCO: Class A and B (low risk) and Class C and D (high risk). It takes about six months to move Class A and B devices and more than eight months to move Class C and Class D devices through the regulatory process, respectively.
Having a predicate device already approved in India simplifies the process with supporting data. Without a predicate, clinical trial data must be provided to demonstrate safety and efficacy. The CDSCO mandates the use of National Accreditation Board for Testing and Calibration Laboratories (NABL), which are accredited labs for testing and performance evaluations.
Other APAC Countries
APAC represents more than 60% of the world’s population and serves as a growth engine for medical device companies, but commercialization success in the region requires country-specific strategies due to high regulatory diversity. The region offers tremendous opportunities with some areas allowing first-to-market entries, but companies must navigate unique local requirements and build strong regulatory partnerships.
The major markets in the region include China and South Korea, particularly from a revenue perspective. Beyond these are smaller and emerging markets: Southeast Asia (often clustered around Singapore), Taiwan, Hong Kong and markets near India. Companies typically organize their regional teams around these clusters.
Market Entry. Success in APAC requires understanding market-specific regulatory requirements, building strong local partnerships and tailoring product registration strategies to each country. Engaging with regulatory authorities helps companies stay informed about evolving regulations.
Innovation pathways provide opportunities for novel technologies, but careful planning, clinical evidence alignment and proactive regulatory engagement are essential for smooth market entry and compliance.
Regulatory Landscape. Regulatory frameworks vary widely across APAC. China has undergone rapid changes, while markets such as Hong Kong and New Zealand have limited or no oversight, making them ripe with product introduction opportunities. Emerging markets like Laos, Brunei and Myanmar are developing regulatory frameworks.
Across the region, regulations are evolving rapidly, particularly for digital technologies, cybersecurity, artificial intelligence and machine learning.
In some markets such as Singapore, Thailand, Vietnam and the Philippines, companies can submit a basic standard dossier, and broader initiatives are underway to align with global requirements.
Some markets in the region are members of the International Medical Device Regulators Forum (IMDRF), while others participate in the Global Harmonization Working Party, which covers most markets. Regional associations, such as the Asia-Pacific Economic Cooperation (APEC), engage with companies to solve specific issues.
Korea, Australia and Singapore are not dependent on prior approvals elsewhere, so companies can target these markets first. China also offers this possibility through its Green Channel, an accelerated pathway for the examination and approval of innovative medical devices.
Extensive clinical data is critical in all APAC markets. Limited evidence, such as a 510(k) clearance, may require local trials or supplementary studies to demonstrate product safety and efficacy.
Understanding the distinction between legal and physical manufacturers is also important. South Korea and Taiwan mandate approvals for physical manufacturing sites. Conflicts between a product’s country of origin and manufacturing location must be managed carefully to ensure compliance.
Smaller markets often require prior approval in a primary market in the form of a Certificate of Free Sale or foreign government certification. Southeast Asia allows submissions with a common dossier template, but most markets require a customized approach.
Consider the Possibilities
OUS markets accounted for more than $20 billion in sales in 2024, 33% of the global orthopedic market. The countries above present inherent challenges to long-term success, but also plenty of incentives to dedicate resources to understanding and navigating the local regulations. As Dr. Vaidya said, “If you’re not building or plan on being in India right now, you’re missing a significant opportunity.”
