Overview

This webinar will offer an overview on the pre-market and post-market processes including: registration submission processes, guidance compliance on medical device registration and clinical trials, product re-calls and overseas inspections. During the webinar you will also be shown an animal-derived product registration case study that was conducted in China.

Learning objectives 

• Have an overview on the pre-market process including: official submission organisation summary, regulation/guidance compliance on medical device registration and clinical trial
• Have an overview on the registration submission process
• Learn about the post-market process including: UDI, ADR, product re-call, overseas inspection 
• Receive an update on NMPA regulation

Outline

• Framework for medical device regulation in China
• Risk classification
• Registration pathways for medical devices in China
• Alternative pathways: Hong Kong, GBA, Hainan
• Clinical evaluation and exemptions for registration
• Cost and timeline
• Local authorised representative requirements

Target audience  

Regulatory affairs professionals with 2-5 years' experience who are interested in NMPA registration.

Presenters

HAMISH KING

CEO of Cisema Group

Hamish King, LLB, RAC is CEO at Cisema, a regulatory and compliance consultancy for China founded in Munich and Beijing in 2002. Cisema is a 100-strong family-owned company providing regulatory and compliance services for China and Hong Kong, including product registration, in-China testing, clinical studies and writing, regulatory communications, local agent, post market surveillance, quality control and audits. A lawyer by training - admitted in Hong Kong and NSW, Australia - Hamish previously worked with UK Magic Circle Firm Linklaters in Hong Kong, and has over 10 years' experience in the legal and regulatory fields. He has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China regulatory pathways and registration points, he currently lives in Hong Kong and specializes in NMPA registrations and compliance.

VICTORIA CALDY

Business Development & Marketing Director Cisema Group

Victoria has over 25 years’ experience in diverse health-related companies including helping to build a class III medical device company from the bottom up which included navigating international regulatory approvals. More recently, Victoria has been advising Life Sciences, Cosmetics and Health Food companies worldwide, from start-ups to MNCs, on the best regulatory pathways to market in China and how to maintain compliance in such a complex market.

CPD

How do I register?

Prices

Discounted Places

A limited number of discounted places are available at the rates below for those:

• in low income countries as defined by the World Bank
• working for agencies, charities or NGOs. 

Please email meetings@topra.org for a discount code before making your booking.

* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.