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Hainan Asks Pilot Trial of Imported Neurological Products

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Hainan Lecheng Boao International Medical Pilot District released “Pilot Trials of International Innovative Neurological Products” on March 29, 2022, to solicit imported products from neurological device manufacturers, research institutions and hospitals. The deadline is April 24, 2022.

Product Requirements

  1. Medicines or devices for the prevention and treatment of neurological diseases
  2. Approved overseas but not yet registered in China
  3. The product performance meets the urgent clinical needs, and are innovative or have other advantages

Submitting Materials

  1. Product Information Sheet
  2. Product introduction PDF (acceptable for both foreign language and Chinese)

If the conditions are met after review, the Lecheng Administration will notify the enterprise to start the import and use of the products.

What Devices are Approved?

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, both were approved in 2021.

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.

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