Events

China Regulatory Workshop

November 19, 2024 | 11:30 AM – 6:30 PM PT
November 20, 2024 | 8:15 AM – 4:00 PM PT

Register now

Receive the latest updates on regulatory requirements and developments in China’s dynamic medical device market.

China Regulatory Workshop

November 19, 2024 | 11:30 AM – 6:30 PM PT
November 20, 2024 | 8:15 AM – 4:00 PM PT

Register now

  1. Overview
  2. Agenda
  3. Speaker
  4. Pricing
  5. Location & Housing

China Regulatory Workshop

November 19, 2024 | 11:30 AM – 6:30 PM PT
November 20, 2024 | 8:15 AM – 4:00 PM PT

Register now

China’s regulatory system continues to evolve rapidly to meet the growing needs of patients, providers, and manufacturers within the world’s second-largest medtech market.  This workshop will take a deep dive on product registration, including various pathways and strategies. It will also dissect Order 739’s key changes to clinical evaluation and post-market surveillance since 2021. The session will also look ahead to expected changes in the next few years, based on a just-released medical devices management law draft that offers important clues.

Join AdvaMed and Biocom for this in-person workshop to enhance your understanding of China’s regulatory landscape. Grasp the key regulations, guidelines, and standards to better navigate this crucial market and shorten time-to-market.

This event is co-hosted by:

Download a copy of the 2024 Workshop agenda draft.

How to Secure NMPA Pre-market Approval and Post-market Compliance 

*Schedule reflects Pacific Daylight Time  

Day One (Tuesday, November 19)

12:30 pm – 1:45 pm

The Law and Regulations and Evolution 

  • General requirements and process for NMPA registration  
  • The regulatory framework and evolution 
  • Classifications and administration 
  • Prerequisites for NMPA submission as a foreign medical device 
  • Overview of registration approvals and trend analysis  

2:45 pm – 3:00 pm

Networking Break  

4:15 pm – 5:30 pm    

Special Process to Expedite Pre-market Approval  

  • Taking advantage of NMPA green channels for expedited approval 
  • Special process for innovative medical devices 
    • Criteria for eligibility and processing of application 
    • Who would benefit more? 
  • Preferential review & approval for products with urgent need 
    • Eligibility and what products are qualified 
    • Products for rare diseases 
  • Special policy in Hainan province for medical device without need for NMPA registration 
  • New Policy for urgent medical needs in Great Bay Area  

Day 2 (Wednesday, November 20)

9:00 am – 10:00 am

Clinical Trials in China

  • How to determine if clinical trial is needed, and
    clinical evaluation through predicate equivalency
    could not be accepted
  • Submission with foreign clinical trial data without
    in-China trial
  • Steps of conducting clinical trials in China
  • Quality requirement (GCP) and inspection for
    clinical trial
  • NMPA pre-approval for clinical trial for high-risk
    devices
  • MOST’s pre-approval for clinical study using
    human genetic resource (*MOST stands for
    Ministry of Science and Technology)

11:15 am – 11:30 am

Networking Break

12:45 pm – 1:45 pm

Networking Lunch

2:45 pm – 4:00 pm

Post-market Compliance

  • Overseas manufacture online or on-site
    inspection
  • Legal responsibilities of local legal agent and the manufacturer
  • Adverse event reporting and re-evaluation requirements:
    • Understanding definition of adverse event
    • When, how and who to report and reevaluate?
  • Annual Self-Inspection Report for Manufacturer’s
  • Quality Management System (QMS)
  • Periodic Risk Evaluation Report for device registered
  • Recall requirement: what, when and who shall it be reported and executed?
  • Post-market product test against PTR
  • Product labeling, advertising and distribution license

Meet the Speaker

Davey Han, M.D., M.S.

Founder and CEO of BioHan Biotechnology Consulting (Beijing) Co. Ltd., dedicating to medical device & IVDs submission, clinical evaluation, quality compliance, as well as government policy & market research in China.

Dr. Han has broad experiences from government agency, academies and the medical industry. He worked for the Chinese Academy of Medical Sciences, and National Health Economics Institute of the Ministry of Health. Then, he entered into the global high-tech medical device industry, including St. Jude Medical and Siemens Healthcare, with various key positions as regulatory affairs manager, Asian-regional senior manager, general manager of quality & regulatory affairs, and director for government & key customer relations. From 2010 to 2013, Dr. Han joined the world’s largest healthcare market research consulting firm – IMS, leading the IMS China Institute and government relations.

Registration Pricing

Click here to check if your company is an AdvaMed member*.

  • AdvaMed Members: $1,795*
  • AdvaMed Accel Members: $1,295
  • Non-Members: $2,225
  • Government/Non-Profit: $1,295

*Biocom California members qualify for the AdvaMed member rate

Event Location

This 2-day workshop will take place in Biocom California Headquarters in The Alexandria at Torrey Pines

10996 Torreyana Rd, San Diego, CA 92121

Hotel Information

Hilton La Jolla Torrey Pines

10950 N. Torrey Pines Road

La Jolla, CA 92037

Rooms are available at a discounted rate of $199 per night plus a $36 per night resort fee* and taxes. To book a room, you must register for the workshop, a link will be provided after confirmation. Sleeping rooms must be secured before October 19, 2024 and with a valid credit card and are refundable up to 3 days in advance of arrival if cancelled.  

*Resort Fee includes the following amenities:

  • 2 glasses of house wine or 2 tap beer of choice at the bar
  • Wi-Fi Access
  • 2 bottles of water per day
  • Access to Shiley’s Sports Complex
  • Resort games, toys and yoga equipment
  • 20% gift shop discount
  • 15% off Torrey Pines Pro Shop

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