Nǐ hǎo

Which photo best depicts your China regulatory strategy?

Last week I attended an excellent webinar sponsored by RAPS presented by Grace Fu Palma CEO of China Medical Devices (gpalma@chinameddevice.com). Grace provided the attendees with a very clear summary on the philosophies of the intended Chinese NMPA (ex-CFDA, ex-SFDA) programme for medical device and IVD legislation. Regulatory affairs team should always seek to obtain an understanding of the preamble and basis for health authority rationale which supports decision making thinking when determining your best approach to regulatory compliance.

The NMPA was very busy in 2020 and released 396 guidelines and notices. Such a surge surely exemplifies the impression that medical device and IVD regulation certainly looms large on their list of objectives.

The lists below provides a small sample for each category:

Industry Standards
Medical Electronic Equipment Part 2-56: Requirements for Basic Safety and Performance of Thermometers
Surgical Implants. Active Implantable Medical Devices Part 5: Circulation Support Devices
Ophthalmic Optics Intraocular Lens Part 8: Basic Requirements
YY/T 1752-2020 Basic Data Set of Medical Device Unique Identification Database
YY/T 1753-2020 Guidelines for Filling in the Unique Identification Database
Reagents (kits) for nucleic acid amplification detection – Implementation 01 Jan 2021
Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 1: General requirements for datasets
Technical Review Guidelines
Guidelines for the Technical Review of Allowable Changes in In Vitro Diagnostic Reagents (Draft for Comments)
Technical Guideline on Raw Material Change Evaluation of a Non-active Device
Technical Review Guideline on Medical Device Software
Quality and Post Market Surveillance
Regulations on Surveillance and Sampling Inspection of Medical Device Quality, NMPA, 2020 #9
Specification on regular risk evaluation report of medical devices
Guidelines on Product Adverse Event Risk Assessment for Medical Device Registrants
Clinical Evaluation
Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation
Class III Medical Devices Requiring Clinical Trial Approval Catalogue (draft for comments)
Revised list of medical devices exempt from clinical trials (draft)

Many of these 396 new/updated/draft documents affect both external and domestic companies manufacturing for the Chinese market. For those corporations operating outside of China, it is vital for the global regulatory team, especially those responsible for global strategy, to ensure a thorough understanding of each document and not just rely on the translation.

Having lived and worked in many countries (including China), I truly understand the level of patience and perseverance required to successfully navigate multicultural segues. Regular communications, clear demarcation of responsibilities for project activities and real time regulatory data exchange processes, pillared in conjunction with cross cultural understanding (important whenever you are engaging with any local team) will effectively support regulatory compliance management.  

The brilliant NMPA presentation concluded with an emphasis on additional legal responsibilities for all players in the medical device marketing and supply chain, including an increase in penalties for non-compliance.

Regulatory Affairs teams: Do not rely on the lucky cat.


K Young



Photo by Malvestida Magazine on Unsplash

Photo by Paico Oficial on Unsplash