Budgeting for your market entry into China’s pharmaceutical and medical device industry requires precise financial planning. The National Medical Products Administration (NMPA) administrative fees are a significant part of this budget, and understanding them is crucial to avoid unexpected costs and delays.
Shanghai OMC Medical Technology has translated the official “National Drug Administration Administrative Licensing Fee Catalogue” into a clear, actionable guide. Below, we break down the key costs for domestic and overseas drugs and devices to help you plan effectively.
1. Drug Registration Fees: A Tale of Two Origins
The cost structure differs significantly between drugs produced domestically and those produced overseas, reflecting the varying review resources required.
For Overseas-Produced Drugs (Imported Drugs):
- New Drug Registration:
- Clinical Trial Application: ¥376,000
- Marketing Authorization Application: ¥593,900
- Generic Drug Registration:
- Marketing Authorization (without clinical trials): ¥367,600
- Marketing Authorization (requires clinical trials): ¥502,000
- Supplementary Application (Requiring Technical Review): ¥283,600
- Drug Re-registration (every 5 years): ¥227,200
For Domestic-Produced Drugs:
- New Drug Registration:
- Clinical Trial Application: ¥192,000
- Marketing Authorization Application: ¥432,000
- Generic Drug Registration:
- Marketing Authorization (without clinical trials): ¥183,600
- Supplementary Application (Requiring Technical Review): ¥99,600
Key Takeaway: The fees for overseas-produced drugs are substantially higher, especially for new drug marketing authorization and supplementary applications. This underscores the importance of a flawless submission to avoid costly re-submissions.
2. Medical Device Registration Fees: Class & Origin Matter
Similar to pharmaceuticals, device registration fees are tiered based on the device’s classification and whether it is manufactured domestically or imported.
For Imported Medical Devices:
- Class III Devices:
- First Registration: ¥308,800
- Change Registration: ¥50,400
- Renewal of Registration: ¥40,800
- Class II Devices:
- First Registration: ¥210,900
- Change Registration: ¥42,000
For Domestic Medical Devices (Class III only):
- First Registration: ¥153,600
- Change Registration: ¥50,400
- Renewal of Registration: ¥40,800
Note: Clinical trial applications for high-risk devices cost ¥43,200, regardless of origin.
3. Strategic Insights & Cost-Saving Opportunities
Beyond the raw numbers, the fee schedule reveals critical strategic opportunities.
- The “Per Specification” Surcharge: For both drugs and devices, adding a new specification increases the base registration fee by 20%. This makes your initial specification strategy vital for cost control.
- The SME Incentive: A major financial advantage exists for qualifying Small and Micro Enterprises (SMEs). Registration fees for innovative drugs and innovative medical devices are waived. This can represent a saving of over ¥300,000, making the “innovative” designation highly valuable.
- The High Cost of Changes: For imported drugs, a supplementary application requiring technical review (¥283,600) is a significant expense. Proactive regulatory strategy to minimize major post-approval changes is essential for cost-efficiency.
Partner with Shanghai OMC for Financial and Regulatory Success
Navigating the NMPA’s fee structure is just the first step. The real challenge is integrating these costs into a successful regulatory strategy that avoids expensive pitfalls like rejected applications or unnecessary supplementary reviews.
Shanghai OMC Medical Technology offers more than just guidance—we provide strategic partnership to optimize your investment:
- Accurate Cost Forecasting: We provide detailed budget projections based on your specific product portfolio and registration pathway.
- SME Eligibility Assessment: We help you determine if you qualify for the innovative product fee waiver and assist with the application process.
- Strategic Registration Planning: We develop strategies to minimize the need for costly supplementary applications and optimize your specification list to avoid surcharges.
- End-to-End Project Management: From dossier preparation to fee payment, we ensure every step is completed accurately and on time, protecting your financial and regulatory investment.
Ready to demystify the cost of entering the Chinese market? Contact Shanghai OMC Medical Technology today for a personalized fee analysis and regulatory roadmap. Let our expertise turn complex fee schedules into a clear and cost-effective path to approval.
