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Boston Scientific Obtained Two NMPA Approvals through Hainan RWD


The NMPA granted approvals to two devices, Boston Scientific’s Rezūm Water Vapor Therapy equipment, and its disposable prostate treatment accessory on March 3, 2022. It only took four months for the two devices from submitting the registration application to guaranteeing approval.

The two devices utilized the same pathway, Hainan Real-World Data program, as Allergan’s glaucoma drainage system, and J&J’s femtosecond laser eye treatment system.

What are the Devices?

Rezūm Water Vapor Therapy is a non-surgical treatment that uses the natural energy stored in water vapor, or steam, to remove excess prostate tissue that is pressing on the urethra.

Rezūm Therapy is typically performed right in your urologist’s office, or at an outpatient surgery facility and completed in one short appointment.

During each 5-8 minutes treatment, sterile water vapor is released throughout the targeted prostate tissue. When the steam contacts the prostate tissue, all the stored energy is released into the tissue. Your doctor will determine the times of treatments you need, based on the size of your prostate.

Over time, your body’s natural healing response absorbs the treated tissue, shrinking the prostate. With the extra tissue removed, the urethra opens, reducing BPH symptoms.

Second Batch of Real-World Data Imported Device

45 imported devices and drugs were included in the second batch of real-world data program in Lecheng Pilot District, Hainan, starting from October 2020, compared to 11 medical products 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, many 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, 2021, 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:

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

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

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