• EnglishEnglish
    • Deutsch Deutsch
    • Italiano Italiano
    • Français Français
    • 日本語 日本語
    • 한국어 한국어

CISEMA - China Zertifizierung, Einkauf und Qualitätssicherung

  • Services
    • NMPA Registration – Medical Devices and IVDs
    • NMPA Registration & DMF – Pharmaceuticals
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • CML (China Manufacture Licence) – Pressure vessels
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Whitepapers
    • FAQ – NMPA Registration – Medical Devices and IVDs
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Sharp Increase of Overseas Applications to enter the Hainan Boao Lecheng International Medical Tourism Pilot Zone

Sharp Increase of Overseas Applications to enter the Hainan Boao Lecheng International Medical Tourism Pilot Zone

Overseas
Friday, 05 June 2020 / Published in Medical Device

Sharp Increase of Overseas Applications to enter the Hainan Boao Lecheng International Medical Tourism Pilot Zone

On 18.05.2020, the Hainan MPA (Medical Products Administration) announced a total of 47 overseas applications received for the second round of medical devices to enter the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Pilot Zone), an increase of 292% compared to the previous round.

In addition, the NMPA also recently held a webinar with Allergan, the US global pharmaceutical company that was recently acquired by AbbVie Inc, about the approval of Allergan’s product via the Hainan Pilot Zone. We have reported on that separately here.

Since the US firm Allergan’s glaucoma drainage tube was approved by the NMPA on 26.03.2020 to become the first imported medical device utilizing real-world data to register in China, more foreign MedTech manufacturers have been showing interest and actively participating in the Hainan Pilot Zone.

During the registration process of Allergan’s glaucoma drainage tube, the NMPA also utilized the real-world data collected in Hainan’s Pilot Zone to evaluate ethnic diversity among patients.

As of 09.05.2020, 42 batches of overseas medical devices were approved for import to urgently support the clinical treatment of 284 patients in medical institutions located in the Hainan Pilot Zone.

By Jacky Li. Contact Cisema to learn more.

What you can read next

New Medical Device Classification Catalogue in Draft
Technical Guidelines Essential Principles
Technical Guidelines for Essential Principles of Safety and Performance of Medical Devices
NMPA Strengthens Supervision of Medical Devices for China Procurement

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Health Food
      • Medical Device
      • Pharmaceuticals & DMF
    • RoHS
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • China medical device sampling inspection results

    China medical device sampling inspection results no.4 of 2022

    China medical device sampling inspection result...
  • NMPA cosmetic sampling inspection

    The NMPA Cosmetic Sampling Inspection measures come into force on March 1, 2023

    NMPA Cosmetic Sampling Inspection Measures come...
  • China cosmetics quality safety responsibilities

    China cosmetics quality and safety responsibilities regulations released

    China cosmetics quality and safety responsibili...
  • China cosmetics efficacy claims FAQ

    China cosmetics efficacy claims FAQ available to answer key questions

    China cosmetics efficacy claims FAQ is availabl...
  • China cosmetics GMP inspections

    China cosmetics GMP inspections points have been finalised

    China cosmetics GMP inspections points and judg...

Archive

Cisema

With twelve locations and over ninety highly qualified employees, Cisema can offer you optimal support in China.

Services

  • Certification
  • Sourcing and Quality Control
  • Logistics and Customs Support
  • Sales Support

Dialogue

  • Contact us
  • Newsletter Signup
  • Events
  • News & Knowledge
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2021 Cisema. All rights reserved.

TOP
Cookies on Cisema
Learn more about Cisema's Privacy Policy.