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How to Secure NMPA Premarket Approval and Postmarket Compliance

December 3, 2019 to December 4, 2019
Washington, DC
Legal and Compliance, Regulatory, Global
Workshop

In this workshop, industry experts will provide an in-depth guide on how to secure regulatory approval in China. This unique opportunity will help you better understand China's approval process, from different types of submissions to post-market compliance. 

Agenda Topics Include:

  • Laws and regulations
  • Regulatory framework and evolution
  • Expediting pre-market approval
  • CMDE/NMPA review process
  • Post-market compliance
  • And more!

Download full agenda

 

Download Agenda

Tuesday, December 3, 2019

 

9:00 am – 10:15 am

The Law and Regulations

  • The regulatory framework and evolution
  • Pre-requisites for NMPA submission as a foreign medical device
  • 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
  • General process and requirements for NMPA registration

10:15 am – 10:30 am

Networking Break

10:30 am – 11:30 am

Strategy for Submission and Clinical Evaluation

  • 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
  • How to determine if clinical trial in China is needed, and when clinical evaluation through predicate equivalency is acceptable
  • Alternative forms of clinical evidence as opposed to a clinical trial

11:30 am – 12:30 pm

Submission with Foreign Clinical Trial Data without in-China Trial

  • Background of the new policy
  • What are the benefits from this new policy, and who should pursue?
  • Principles and requirements for acceptance of foreign clinical trial data
  • How to determine the acceptability of foreign clinical trial – introduction of an internal assessment worksheet
  • When the clinical data on Chinese population is necessary and how to fulfill
  • Best practice sharing on demonstration of no difference on the patient population

12:30 pm – 2:00 pm

Lunch

2:00 pm – 3:15 pm

Special Process to Expedite Premarket Approval

  • Taking advantage of NMPA green-channels for expedite approval
  • Special process for innovative medical device
    • Criteria for eligibility and process for application
    • Who would benefit more?
  • Preferential review & approval for products in urgent need
    • Eligibility and what products are qualified
    • Product for rare diseases
  • Special policy in Hainan province for medical device without need of NMPA’s registration
    • Humanitarian Devices Exemption

3:15 pm – 4:30 pm

Clinical Trial or Evaluation Requirement

  • How to conduct clinical evaluation through predicate equivalency
    • Selection of a predicate(s)
    • How to determine equivalency with predicate, or justify for non-significance if there is any difference
    • Searching and collecting clinical data/literature
    • Data (META) analysis, when data subset is required
    • Clinical evaluation report
  • Steps to conduct clinical trial in China
  • Quality requirement (GCP) and inspection for clinical trial
  • NMPA pre-approval for clinical trial with high risk devices
  • MOST’s pre-approval for clinical study using human genetic resource

4:30 pm – 6:00 pm        

Reception

Wednesday, December 4, 2019

 

9:00 am – 10:00 am      

Type Testing Requirement

  • The legal basis for type testing (political basis for why type testing needs to be done by NMPA test lab)
    • Type test of registration
    • Entrused-commercial test
  • How to determine what specifications shall be tested and can be accepted and composite Product Technical Requirement (PTR)
    • Standards mandatory or recommended for use;
    • Technical Guidance
    • Functionality/performance claimed
    • Special requirement for AI device and medical software
  • Role of test laboratory NMPA-accredited
  • Potential acceptance of test report done by manufacturer’s in-house test lab or third party

10:00 am – 10:15 am    

Networking Break

10:15 am – 11:30 am

CMDE/NMPA Review Process

  • Organization, roles and workflow
  • Acceptance of submission dossier
    • Electronic submission
  • Interacting with NMPA before and during review process
  • 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
    • GMP audit
    • Others...
  • Overseas manufacture site inspection during review or postmarket

11:30 am – 12:30 pm    

Lunch

12:30 pm – 1:30 pm

Regulatory Updates in 2019 and Foreseeing Future
Development

  • Expanding Market Authorization Holder (MAH) program
  • Implementing UDI system for the key products as 1st batch
  • Launching Hainan pilot program for Real World Clinical
    Evidence
  • Facilitating registration for rare diseases medical devices
  • Releasing particular provision for customized medical device
  • Participating international safety information exchange
    (National Competent Authorities Report, NCAR)
  • Regulatory Amendment and future development
    - More legal responsibility of entity and personnel;
    - Clinical trial exemption expansion;
    - Manufacturer’s in-house test report;
    - Exemption of COO’s approval for innovative
    product;
    - Clinical trial extension to benefit more patients in
    urgent need;
    - Recognition of single QMS audit;
    - Facilitation of AI and medical robotic devices;
    - MAH expansion to overseas device
    manufacturer/developer.

1:30 pm – 1:45 pm

Networking Break

1:45 pm – 3:30 pm        

Postmarket Compliance

  • Joint responsibilities of local legal agent and the manufacturer
  • Post-market Surveillance: AE reporting and recall requirements
  • Product/packaging labeling, IFU requirement and product import inspection
  • Postmarket product inspection against PTR
  • Distribution license, and product promotion/advertising
3:30 pm            

Closing Remarks

Ralph Ives, Executive Vice President, Global Strategy and
Analysis, AdvaMed

3:35 pm            

Adjournment

 

 

Davey Han, MD, MS

Davey Han, M.D., M.S. is Founder and CEO of BioHan Biotechnology Consulting (Beijing) Co. Ltd., which is dedicated to provide the services in medical device and IVDs for CFDA submission, pre-market clinical evaluation, quality compliance, as well as government policy & market research. Dr. Han has broad experiences from government agency, academies and medical industry. He worked for Chinese Academy of Medical Sciences, and National Health Economics Institute of MOH. Then, he entered into global high-tech medical device industry including St Jude Medical and Siemens Healthcare, with various key positions including regulatory affair 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 largest healthcare market research consulting firm - IMS, leading the IMS China Institute. Dr. Han is very active in communication and exchanges between device industry and government authorities. When employed by industry companies, he took many social roles respectively, including Chair, Medical Device Forum of American Chamber of Commerce in China; Co-Chair, Health Equipment Working Group of European Chamber of Commerce in China; Chair of COCIR in China, Vice Chair of Asian Harmonization Working Party (AHWP) in medical device regulations and standards, and China Director of Medical Imaging and Technical Alliance (MITA, a NEMA division). Dr. Han graduated from Tongji Medical University in 1984. From 1993 -1997, he studied at the University of Minnesota and earned the Master of Science in Health Services Research and Policy, and also completed his post-doctorate program in Epidemiology and Clinical Research at the same university.

Susan Xue

Susan works as independent senior regulatory affairs consultant at Biohan Consulting, helping client companies explore and achieve business goals in China by providing regulatory strategies and execution guidance. Before that, Susan headed regulatory affairs for all the product lines of St. Jude Medical (now part of Abbott Laboratories) in China. During her 20 plus years of contributions in the company, Susan recruited, trained, and led a strong team of professionals that successfully navigated a complex and changing regulatory environment in China for hundreds of imported medical consumable products and equipment from the United States and European Union. She has deep and extensive regulatory affairs knowledge and experience, including the handling and overseeing of conventional and innovative expedited submissions, type testing, inspections, clinical strategies, panel meetings, physician advisories, and product recalls. Susan is known in the industry for her professionalism and collaborative approach, and has worked effectively with various industry groups, government and regulatory agencies.

Susan was Vice Chair of the China Association for Medical Devices Industry Expert Committee, focusing on the training and exchange of regulatory compliance professionals. She also served on the China Society for Drug Regulation’s International Exchange and Cooperation Research Committee. Susan earned a Bachelor of Science from the prestigious Ocean University of China and currently resides in both China and Canada.

How to Secure NMPA Premarket Approval and Postmarket Compliance will take place December 3-4 at the Airbus Experience Center - Washington Room North & South.

Click here for a list of recommended hotels.

Address:

Airbus
1101 Pennsylvania Avenue, NW, Suite 800
Washington, DC 20004

Registration Fees

AdvaMed Member Registration: $1,595.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $2,095.00

Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by November 27th for $200 off your registration.