Medical Devices
NMPA published a notice addressing the work items for medical device sampling inspection, reinspection, objections and appeals, etc.
The NMPA drafted a guidance document to include human factors/usability engineering (HFE) for the registration of medical devices.
The Standardization Administration of China released the GB 9706.1-2020 addressing new safety and performance requirements for medical electrical equipment.
Once a medical device is approved for use within the Pilot Zone, hospitals can use a special pathway to apply for NMPA registration in China.
NMPA solicites public opinions on the draft proposal to reclassify IVD reagents in the 6840 Classified Subdirectory (2013 Version).
The UDID was officially released to the public, allowing users to use the search tool, download, and data sharing features.
Hainan MPA utilizes real-world data application and other measures to enhance the healthcare industry development in the Hainan Free Trade Zone.
The NMPA made temporary rearrangements for the submission of notarized documents for medical device registration applications due to the COVID-19 outbreak.
Exporting coronavirus protection supplies in China requires the declaration of conformity and the overseas product registration certificate.
In response to the coronavirus epidemic, NMPA guides the suitable pathway for the registration application of different types of medical supplies in China.
The NMPA announced the fast-track approval for Edwards Lifesciences’ transcatheter valve repair clip device, utilizing the special review procedure.
On 29.04.2020, the National Center for Adverse Drug Reaction (ADR) Monitoring of NMPA (National Medical Products Administration) released its 2019 Annual Report, providing an overview of China’s progress for medical device adverse event monitoring and reporting. Key highlights are:
The total number of adverse event reports reduced by 2.61%
In 2019, there were 396,345 adverse events reported in China, a decrease of 2.61% as compared to 2018.
Severe injury reporting cases decreased sharply by 10.17%
In 2019, 0.05% (213 reports) of the total adverse events reported death cases, an increase of 70.6% as compared to 2018.
In 2019, 6.74% (26,723 reports) of the total adverse events reported severe injury cases, a significant decrease of 10.17% as compared to 2018.
Mainly medical institutions and consumers
In 2019, 357,799 adverse events were reported by users (medical institutions and consumers), 8,600 adverse events were reported by NMPA Legal Agents and 29,833 adverse events were reported by manufacturers.
42.07% of the total adverse events reported related to infusion, care and protective equipment
Medical Devices
(According to the NMPA Classification Catalogue for Medical Devices [2017])Number of
Adverse Events Reports% of Total01 Active Surgical Instruments3,5980.91%02 Passive Surgical Instruments10,1542.56%03 Nerve and Cardiovascular Surgical Instruments2,3490.59%04 Orthopaedic Surgical Instruments7170.18%05 Radiation Therapy Equipment6060.15%06 Medical Imaging Equipment8,7872.22%07 Medical Examination and Monitoring Equipment35,1698.87%08 Respiratory, Anaesthesia and First Aid Equipment18,2264.60%09 Physical Therapy Equipment23,1815.85%10 Blood Transfusion, Dialysis and Extracorporeal Circulation Devices10,8892.75%11 Medical Device Disinfection and Sterilization Equipment1,9120.48%12 Active Implant Instruments5830.15%13 Passive Implant Instruments3,3130.84%14 Infusion, Care and Protective Equipment166,73442.07%15 Patient Carrying Devices1,4680.37%16 Ophthalmic Instruments5,7431.45%17 Stomatology Instruments4,3941.11%18 Obstetrics and Gynaecology, Assisted Reproductive and Contraceptive Devices12,9713.27%19 Medical Rehabilitation Equipment8160.21%20 TCM Equipment4,1791.05%21 Medical Software720.02%22 Clinical Testing Devices19,7254.98%IVDs2,9350.74%Pending for categorization57,82414.59%Total396,345100%
By Jacky Li. Contact Cisema to learn more.
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