China Regulatory Workshop
November 19, 2024 | 11:30 AM – 6:30 PM PT November 20, 2024 | 8:15 AM – 4:00 PM PT
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
China Regulatory Workshop
November 19, 2024 | 11:30 AM – 6:30 PM PT November 20, 2024 | 8:15 AM – 4:00 PM PT
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, Nov 19) | |
|---|---|
| 11:30 am – 12:30 pm | Check in & Networking Lunch |
| 12:30 pm – 1:45 pm | The Law and Regulations and Evolution The regulatory framework and evolution Classifications and administration Prerequisites for NMPA submission as a foreign medical device Overview of registration approvals and trend analysis General requirements and process for NMPA registration |
| 1:45 pm – 2:45 pm | Different Types of Submission and Strategy Different types of submissions New submission for registration Submission for change of registration (re-submission) Submission for renewal without change Filing for Class I device Filing for IFU change How to determine when re-submission for change is needed, and if re-submission rather than a new submission is acceptable How to determine if a new submission rather than re-submission is necessary |
| 2:45 pm – 3:00 pm | Networking Break |
| 3:00 pm – 4:15 pm | Clinical Evaluation based on Data from Predicate Equivalent and Literature Options and pathway for clinical evaluation Principles for clinical evaluation based on predicate equivalency Types and uses of clinical and non-clinical data Strength level of clinical data as evidence Literature Real world clinical data Post market surveillance Clinical trials When and what clinical database/raw data is required for submission How to determine the right strategy for clinical evaluation |
| 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 |
| 5:30 pm – 6:30 pm | Networking Reception |
| Day Two (Wednesday, Nov 20) | |
|---|---|
| 8:15 am – 9:00 am | Networking Breakfast |
| 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) |
| 10:00 am – 11:15 am | Type Testing and Requirement The legal basis for type testing Type test of registration Entrusted-commercial test How to determine what specifications shall be tested and can be accepted Composite Product Technical Requirement (PTR) Standards mandatory or recommended for use Technical guidance Functionality/performance claim Special requirement for AI device and medical software Work with NMPA-accredited lab for obtaining test report Acceptance of test report conducted by manufacturer’s in-house test lab or third party |
| 11:15 am – 11:30 am | Networking Break |
| 11:30 am – 12:45 pm | NMPA/CMDE Review Process and Communication Organization, roles and workflow Acceptance checklist of submission dossier Electronic submission (eRPS) Communication process with NMPA/CMDE* before and during review (*Center for Medical Device Tech Evaluation) How to fulfill the supplementary request (deficiency) during review Consequence if it fails to satisfy the supplementary request, and major causes for failure GCP audit Insufficient clinical data or failure of predicate equivalency Mandatory standard requirement Biocompatibility and toxicology of raw materials QMS inspection during submission and review Others |
| 12:45 pm – 1:45 pm | Networking Lunch |
| 1:45 pm – 2:45 pm | Regulatory Updates and Foreseeing Future Development Medical Device Regulations Amendments 2021 Expanding Market Authorization Holder (MAH) program Transferring import devices registered to be “made in China” Implementing UDI system and GSP requirement for distributors of medical devices Launching Hainan pilot program for Real World Clinical Evidence Participating international safety information exchange (National Competent Authorities Report, NCAR) Exemption of Approval of Country of Origin as prerequisite for innovative products Clinical trial extension to benefit more patients with urgent need Manufacturer’s in-house test report Pilot program for LDT (Laboratory Developed Test) implemented Re-test on GB9706.1 (IEC60601-1) series standard 3rd edition New GB or YY product standards development or modification Temporary import and use of non-registered medical devices in urgent needs by medical institute Future Regulatory Development More legal responsibility of local agent and personnel Clinical trial exemption expansion and Multiple Center Clinical Trial Recognition of single QMS audit Facilitation of AI and medical robotic devices MAH expansion to overseas manufacturer or developer |
| 2:45 pm – 4:00 pm | Post-market Compliance 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 re-evaluate? 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 Overseas manufacture online or on-site inspection |
| 4:00 pm | Program Concludes |
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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