Navigating China’s complex regulatory landscape is critical for healthcare and life sciences companies seeking to enter or expand in the Chinese market. We provide end-to-end legal support across the entire licensing and market access lifecycle—from institutional setup to product registration and public reimbursement. Our team helps both domestic and international clients align their regulatory strategy with business goals, address approval risks, and engage with regulators under evolving policies and pilot frameworks.

Institutional and Product Licensing

• Medical institution setup and licensing

  We assist with licensing for public-to-private conversions, establishment of private and joint-invested hospitals (including Sino-foreign ventures), and internet-based medical institutions.

• Pharmaceutical approvals (IND, NDA, ANDA)

  We advise on China’s drug registration pathway, including clinical trial authorization, marketing authorization, and generics registration strategies.

• Medical device registration and lifecycle management

  Our services cover initial registration, modifications, renewals, and exemptions from clinical trials for medical devices.

• Regulatory filings for cosmetics and disinfectants

  We assist in filing and approval processes for cosmetics, disinfection products, and special-use items.

Market Access Strategy

• Licensing for Foreign and Regional Medical Institutions

  We assist foreign-invested healthcare entities and institutions from Hong Kong, Macau, and Taiwan in navigating China’s licensing procedures for market entry and joint operations.

• Healthcare advertising and digital compliance

  We provide legal review and compliance advice on qualifications for publishing medical ads and presenting healthcare content online.

• Reimbursement and pricing access

  We guide clients through China’s National Reimbursement Drug List (NRDL) application, negotiation process, and compliance reviews.

• Sales and marketing licensing

  We support drug representative registration and other licensing procedures in pilot zones.

• Pilot policies and fast-track programs

  We help clients apply for innovative policies such as the MAH pilot system, fast-track approval for innovative devices, and DRG-based payment pilots.

Regulatory Dispute Resolution

• Challenges to denied, revoked, or suspended approvals

  We represent clients in administrative reconsideration or litigation related to negative licensing decisions or enforcement actions.