Health Sciences

Asia’s health sciences sector presents enormous potential, but it’s also heavily regulated and increasingly scrutinized. Regulatory pathways differ widely across jurisdictions, especially for drug registration, clinical trials, and telemedicine rollout. Companies entering the region often face unfamiliar licensing frameworks, evolving data privacy laws, and inconsistent approval timelines.

We help clients de-risk market entry and manage operational scale by aligning structure, compliance, and strategy across jurisdictions. Our service goes beyond setup—offering long-term regulatory mapping, tax alignment, and digital delivery readiness to support cross-border operations.

Market access depends on the type of health services or products involved—clinical services, digital health, diagnostics, pharmaceuticals, or medical devices. In some countries, direct ownership is possible; in others, investors must partner locally or meet industry-specific capital and experience requirements.

We provide a structured entry plan that accounts for:

• Jurisdiction-specific ownership rules
• Registration requirements for products and services
• Sector-specific licensing frameworks
• Tax and investment incentive availability
• Long-term compliance obligations for regulated sectors

Medical device approval processes vary across Asia, though many countries align with the ASEAN Medical Device Directive (AMDD). Class I–IV device classifications apply, and documentation typically includes product testing data, labeling, and local representation.

We help clients prepare complete submission plans, identify fast-track options, and coordinate with local agents where required. Our team guides firms through pre-market, import, and post-market compliance—not only to get devices approved, but to ensure they remain compliant long after launch

FDI regulations in the health sector are often stricter than in general industries. Some countries permit 100% foreign ownership in areas like diagnostics or biotech, while others impose restrictions for hospitals or patient-facing services.

For example:

• India allows 100% FDI in greenfield hospitals and medical devices
• Vietnam requires specific licenses and may limit certain clinical activities
• China restricts ownership in public hospitals and certain healthcare insurance segments

We help clients structure investments that comply with national laws while maintaining control, operational flexibility, and long-term tax efficiency.

In many cases, yes—especially when services involve direct patient interaction, telemedicine, or public health collaboration. Local partners can help navigate cultural expectations, licensing approvals, and distribution networks. However, they also introduce compliance and control challenges.

We advise clients on when partnerships are legally required vs. when they are commercially strategic. Our support includes partner vetting, JV structuring, and contract review to ensure alignment with ownership, branding, and operational standards.

Timelines depend on the country and the nature of services—whether remote consultations, diagnostics, prescriptions, or full-service telehealth platforms.

Typical timelines include:

• Singapore: ~3–4 months under MOH telehealth guidelines
• India: Variable—depends on clinical model and adherence to national telemedicine framework
• China/Indonesia: More restrictive; may not allow foreign operators or direct cross-border service

We help clients map legal feasibility, prepare submissions, and coordinate with licensing bodies to reduce regulatory delays.

Governments across Asia are encouraging investment in health-related infrastructure and innovation. Special economic zones (SEZs) and industrial parks often offer preferential tax regimes, equipment import exemptions, and streamlined licensing for qualifying projects.

We support clients by:

• Identifying eligible SEZs by country and subsector
• Modeling tax savings and duty exemptions
• Preparing incentive applications and investment approvals
• Ensuring ongoing compliance with grant or zone reporting obligations

Delivering telehealth or cross-border diagnostics requires careful alignment with national data protection laws. Regulations such as Singapore’s PDPA or India’s PDPB impose strict rules on consent, hosting, and cross-border transfers of health data.

We assist by conducting legal gap assessments, developing compliant privacy frameworks, and coordinating with IT vendors on data storage localization. Our support ensures patient trust and regulatory alignment across every step of digital health delivery.