The costs associated with NMPA (National Medical Products Administration) certification for medical devices in China can vary widely based on factors such as the type and classification of the medical device, the complexity of the testing, and the specific requirements for clinical trials or additional documentation. Below is a breakdown of the key cost components:

1. Application Fees

• Device Classification: The cost for the NMPA registration process depends on the device classification (Class I, II, or III).
  • Class I devices: Generally exempt from clinical trials but still require basic registration. The registration fee for Class I devices typically ranges from ¥1,000 to ¥3,000 (approximately USD $140 to $420).
  • Class II and III devices: These devices often require more extensive documentation, including clinical trials, and the registration fees are significantly higher. The fee for Class II devices can range from ¥10,000 to ¥30,000 (USD $1,400 to $4,200), while Class III devices can cost anywhere from ¥30,000 to ¥50,000 (USD $4,200 to $7,000) or more, depending on the complexity.

2. Clinical Trial Costs

• For Class II and Class III devices, clinical trials are often required, and these trials can be expensive. The costs for clinical trials in China can range from ¥200,000 to ¥3,000,000 (approximately USD $28,000 to $420,000), depending on the type of device, the number of patients involved, and the trial duration.
• Class I devices typically do not require clinical trials.

3. Testing Fees (including Lab Tests)

• Preclinical Testing: Testing of the device to ensure it meets safety and performance standards may cost anywhere from ¥50,000 to ¥500,000 (USD $7,000 to $70,000). These fees cover aspects like biocompatibility, electrical safety, EMC (Electromagnetic Compatibility), and performance testing.
• Specialized Testing: If the device falls under specific categories requiring specialized tests (e.g., in-vitro diagnostic devices, implants, etc.), the costs may be higher.

4. Notarization and Translation Costs

• All documentation (including technical files, manuals, and clinical data) must be translated into Chinese. Translation and notarization can be an additional cost. Depending on the volume of material, the translation cost can be around ¥10,000 to ¥50,000 (USD $1,400 to $7,000).

5. Local Agent or Consulting Fees

• Most foreign companies need to appoint a local agent or consulting firm to handle the NMPA registration process. The fees for such services can vary widely depending on the complexity of the device and the firm's reputation. The cost may range from ¥50,000 to ¥300,000 (USD $7,000 to $42,000) or more.

6. Post-market Surveillance and Annual Fees

• Once a device is approved, there are annual post-market surveillance requirements. Companies must budget for renewal fees, which can be anywhere from ¥1,000 to ¥10,000 annually (USD $140 to $1,400), depending on the device's classification and market presence.

7. Additional Fees

• Site Inspections: For Class II and Class III devices, site inspections of the manufacturing facilities may be required. These inspections can add extra costs (travel, accommodation, etc.), ranging from ¥10,000 to ¥50,000 (USD $1,400 to $7,000).
• Registration Maintenance Fees: For ongoing compliance, companies may be required to submit periodic documentation and updates, which may involve additional costs.

Summary of Estimated Costs:

• Class I devices: ¥1,000 to ¥3,000 (USD $140 to $420)
• Class II devices: ¥10,000 to ¥30,000 (USD $1,400 to $4,200)
• Class III devices: ¥30,000 to ¥50,000 (USD $4,200 to $7,000)
• Clinical trials (for Class II and III): ¥200,000 to ¥3,000,000 (USD $28,000 to $420,000)
• Translation and Notarization: ¥10,000 to ¥50,000 (USD $1,400 to $7,000)
• Consulting/Local Agent Fees: ¥50,000 to ¥300,000 (USD $7,000 to $42,000)

Conclusion:

The overall cost for NMPA certification in China can vary greatly depending on the class and complexity of the medical device. Companies must also account for testing, clinical trials, translation, and potential consultation fees. It is advisable to consult with a local regulatory expert or agent to get a more accurate estimate based on your device’s specific requirements.

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