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Within Five Months, Imported Device Got Approval Through Hainan RWD

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The NMPA held a conference in Beijing on December 27, 2021 to discuss the Real World Data program and better enhance the approval system for imported devices.

Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program. The program, which has been piloted in Hainan since June 2019, was joined by eight overseas manufacturers, including some represented by China Med Device.

Timeline of Allergan’s Approval

In the past, imported medical devices spend at least 3 to 5 years to enter the China market. However, from RWD status to final approval, it only took five months for Allergan to list the glaucoma system on the market. Below is the timeline

  • April 2019

Allergan’s Glaucoma Drainage Tube was granted as “urgently needed imported medical device”, which paved the way of doing RWD clinical trial.

  • November 2019

The device officially launched a real-world study, collecting real-world data through practice.

  • March 26, 2020

Allergan’s glaucoma drainage tube became the first medical device product approved for marketing using real-world data. It used clinical real-world evidence collected in the Hainan Boao Lecheng Pioneer District for the evaluation of ethnic differences, avoiding repeated clinical evaluation process.

Second Batch of Real World Data Imported Device

45 imported devices were included in the second batch of real world data program in Lecheng Pioneer District, Hainan, starting from October 2020, compared to 11 devices in the first batch. These products come from 30 large multinational companies, including the following:

  • Boston Scientific
  • Roche Diagnostics
  • Advanced Bionics
  • Zimmer
  • Santen Pharmaceuticals
  • UCB
  • … …

At the same time, a large number of imported medical device products have begun to apply for clinical examination and approval of imported medical devices, so as to be able to borrow the “dongfeng” of real-world data approval. As of December 23, the state has approved 3,930 sets of 75 batches of 103 types of medical devices urgently needed to be imported for clinical use in 1,142 patients.

How to Obtain RWD?

Hainan Boao is the first area in China where RWD can be widely used. NMPA issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” on November 26, 2020. It specifies six ways to acquire RWD:

  1. Data derived from electronic health records (EHRs)
  2. Medical claims and billing data
  3. Data from product and disease registries
  4. Patient-generated data, including from in-home-use settings
  5. Data gathered from other sources that can inform on health status, such as mobile devices.
  6. Data generated from the complete life cycle of the medical device: production, sales, transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.

What Does the Real-World Data Do?

Eleven common situations are listed where real-world evidence can be considered for clinical evaluation of medical devices:

  1. Provide clinical evidence in CER pathway
  2. Provide overseas RWE for globally launched product
  3. Provide in-China RWE to support registration for clinical urgently needed product
  4. Provide external control for single arm study
  5. Provide evidence to build performance goal in single arm study
  6. Support the modification of the scope of application, indications, and contradictions
  7. Support clinical claim change in IFU
  8. Support conditional approvals post marketing data
  9. Support long-term safety and/or effectiveness evaluation of medical devices such as high-risk implants
  10. Support life-cycle clinical evaluation for rare disease product
  11. Support post marketing surveillance

China Med Device can help you evaluate the feasibility of your product and help you conduct RWD in Hainan. info@ChinaMedDevice.com.

Please follow this link for the latest news on Hainan’s RWD program. And this one for our webinar on the Hainan RWD program.

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