• 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
  • Webinars
  • Attend three webcasts with Cisema on February 23 – 25, 2021

Attend three webcasts with Cisema on February 23 – 25, 2021

Monday, 08 February 2021 / Published in Webinars

Attend three webcasts with Cisema on February 23 – 25, 2021

In collaboration with the FORUM Institut, the webcasts will highlight the opportunities and potential of European medical devices and technology on the Chinese market for three consecutive days. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.

The webcasts are aimed at specialists and managers in the medical device and IVD industry who are planning medical device marketing or renewing an existing marketing authorization in China.

Register now through this link to receive a 10% discount.

Agenda

February 23 – Part 1

09:00 – 09:15 Welcome

  • with a short introduction round at the beginning. Each participant could briefly share information about their company and their past experience in China

09:15 – approx. 11:00

Topic: Medical Device Market in China and Introduction to NMPA Registration

  • Market dynamics and potential
  • Access to healthcare facilities
  • Megatrends? Digitalization & selfcare
  • Regulatory bodies: SAMR & NMPA & CMDE
  • Government healthcare
  • Regulatory framework
  • Registration – types
  • Development of product registration/2019 NMPA report
  • NMPA legal agent
  • Market authorization holder system

February 24 – Part 2

09:00 – 09:05 Welcome

09:05 – approx. 11:00

Topic: China Registration

  • Classification of medical devices
  • Registration Processes & timelines
  • Application file checklist
  • PTR (Product Technical Requirement)
  • Standards
  • Type Tests
  • NMPA website and database
  • Chinese label
  • Official fees
  • Clinical pathways: Exemptions, overseas clinical trials, predicate devices (CER), clinical trials in China
  • Customized medical devices
  • Combination products
  • Software & AI regulations, registration, software update

February 25 – Part 3

09:00 – 09:05 Welcome

09:05 – approx. 11:00

Topic: Complete Lifecycle Supervision

  • Post-market surveillance & quality management system
  • Handling of adverse events
  • Recall
  • PRER
  • Sampling inspection
  • Overseas factory inspections

Topic: Other Pathways

  • Fast track: innovation, priority, emergency approval
  • Hainan Pilot Zone
  • Hong Kong MDACS listing & Greater Bay Area
  • CBEC

Topic: Hot Topics & Latest Regulatory Changes

  • Cyber security
  • Chinese company name
  • Lifetime of medical devices
  • Electronic application submission (eRPS)
  • Unique Device Identification (UDI)
  • Medical Device Master File
  • Advertising
  • Human factors design
  • From foreign-to-China
  • Unauthorized claims
  • Penalties
  • Confidentiality code
  • Trade fairs
  • Industry associations

Contact Cisema if you would like to learn more.

Tagged under: NMPA registration, webcasts

What you can read next

Webinar on China certification in cooperation with Advantage Austria
Cisema Participates in Canada’s Regulatory Medtech Conference 2021
Webinar: China’s Digital Healthcare Opportunities and Regulatory Implications

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.