On 25th March, the National Medical Products Administration (NMPA) issued a circular covering 93 ministerial level standards for medical devices in 2019, 59 new standards and 34 revised standards respectively. Five of them are mandatory standards. The newly formulated ministerial level standard items include “Performance Characteristics of Medical Light Ion Beam Equipment for Medical Electrical Equipment”, “Hepatitis B Virus e Antibody Detection Kit (Chemiluminescent Immunoassay),”Fluorescence Immunochromatography Analyzer”, “Deafness Gene Mutation Detection Kit”, “Energy Consumption Measurement Method for Medical Electrical Equipment”, “Medical Instruments for Human Assisted Reproductive Technology Artificial Teaching Seminal catheter, etc., in which the “kit for detection of hepatitis B virus e antibody (chemiluminescent immunoassay)” is a mandatory standard.
The revised ministerial level standard items include “immunohistochemically reagent”, “intradermal needle”, “Medical electrical equipment Part 2-31: Specific requirements for basic safety and basic performance of external cardiac pacemaker with internal power supply”, “Medical electrical equipment Part 2-50: Specific requirements for basic safety and basic performance of infant phototherapy equipment”, “One-time use of human venous blood sampling” Container Collection”, “Special Infusion Device Part 5: Disposable Bottle and Bag Infusion Device”, etc., in which “Medical Electrical Equipment Part 2-31: Specific Requirements for Basic Safety and Basic Performance of External Cardiac Pacemaker with Internal Power Supply”, “Medical Electrical Equipment Part 2-50: Specific Requirements for Basic Safety and Basic Performance of Infant Light Therapeutic Equipment”, “Disposable Use” Human venous blood sampling containers and “special infusion apparatus Part 5: disposable bottle and bag infusion apparatus” are compulsory standards.
The task of revising the standards will be undertaken by the medical device inspection and testing units under the Medical Products Administration of Beijing, Tianjin, Liaoning, Shanghai, Zhejiang, Shandong, Hubei and Guangdong provinces (cities), the Chinese Academy of Inspection (Center for Standard Management of Medical Devices of the State Pharmaceutical Supervision Bureau), the Stemmatological Device Inspection Center of Peking University School of Stomatology, and the Beijing Huaguang Certification Co., Ltd.