Here are the latest China regulatory and clinical affairs news pieces for medical devices and IVDs in February 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Guidance Stipulates How to Write Product Technical Requirements
The NMPA released the “Guideline for Medical Device Product Technical Requirements (PTRs)” on February 9, 2022, directing manufacturers on preparing one of the most important documents submitting to NMPA.
Product Technical Requirements (PTRs) can be divided to following five parts: product model/specification and its classification, performance indicators, inspection method, terminology and appendix(es). The guideline pays special attention on the requirements on performance indicators. It also lists contents that are not recommended to be specified in the performance indicators. Read the original post. And read about PTR related total product life cycle management.
Five Urgent Needed Devices Designated in GBA
Five devices, designated as urgently needed, were enrolled to pioneer the clinical use policy in Greater Bay Area (GBA)- with a total population of approximately 71.2 million people (5% of China’s total population). These products were approved in Hong Kong and Macau and used in public hospitals there. Five hospitals are on the list. Not only tier-3 but also tier-2 hospitals are included. See the full list of devices and user facilities.
Imported Devices Wanted in Hainan Pilot Zone for Insurance Application
“Selection of Urgent Needed Drugs and Medical Devices for Insurance Application” was published by Hainan Boao Tourism Pilot Zone Administration on February 10, 2022. It asks foreign manufacturers to submit the application to get their medical products enrolled in the insurance poll. The deadline is March 31, 2022. See the requirements and procedure of application.
NMPA Q&A on New Registration and Filing Measures
The NMPA released a Q&A to address issues manufacturers are often concerned about “Medical Device Registration and Filing Management Measures” and “In Vitro Diagnostic Reagents Registration and Filing Management Measures”, which have been effective since October 1, 2021. The Q&A mainly answers questions on Class II device registration and quality management system. Read our original post.
Guidelines & Standards
35 National and 146 Industry Standards Issued in 2021
NMPA released the Medical Devices Standards Annual Report on February 18, 2022. In the year of 2021, 35 national standards and 146 industry standards for medical devices were published.
Among the national standards are 18 electrical equipment standards related to GB 9706.1, six clinical laboratory quality and capability standards and two biological evaluation standards. By indications, those of laboratory equipment, imaging, orthopedic surgery, microsurgery, and dental equipment are among the most. See the full list of standards released in 2021.