On April 20, the Chinese Standardization Administration (SAC) released the full contents of 14 national standards for disinfectants, disinfecting instruments, medical electrical equipment including critical care ventilators, of which the most notable one is “GB 388750-2020 Lists of Material and Restricted Substances in Disinfectants”, a mandatory standard without prior consultation, but due to take effect starting from November 1, 2020. Mandatory National Standards Issued under the SAC Announcement 7 of 2020 No. Code and Name Replacement Effective Date 1 GB 9706.1-2020 Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance 医用电气设备 第1部分:基本安全和基本性能的通用要求 GB 9706.1-2007, GB9706.15-2008 2023/5/1 2 GB 9706.212-2020 Medical Electrical Equipment—Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators 医用电气设备 第2-12部分:重症护理呼吸机的基本安全和基本性能专用要求 GB 9706.28-2006 2023/5/1 3 GB 9706.237-2020 Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment 医用电气设备 第2-37部分:超声诊断和监护设备的基本安全和基本性能专用要求 GB 9706.9-2008 2023/5/1 4 GB 27948-2020 General Requirements for Air Disinfectant 空气消毒剂通用要求 GB 27948-2011 2020/11/1 5 GB 27949-2020 General Requirements of Disinfectant of Medical Instruments 医疗器械消毒剂通用要求 GB/T 27949-2011 2020/11/1 6 GB 27950-2020 General Requirements for Hand Disinfectant 手消毒剂通用要求 GB 27950-201

On May 6, 2020, China ICAMA invited a 25-day consultation on a draft list of the measured substances for residue trial and residue definition for dietary risk assessment.

On 30 April 2020, the Chinese Ministry of Agricultural and Rural Affairs (MoARA) has invited public feedback on pesticide MRLs to be integrated into the national standard, ”GB 2763 Maximum Residue Limits for Pesticide in Food”. The deadline for comments is 31 May 2020.

On April 27th, 2020, the Chinese Ministry of Agricultural and Rural Affairs (MoARA) issued the Announcement 275 to eliminate the registration of Metalaxyl-M seed/seedling-use mixtures targeting only blight and bakanae diseases caused by Fusarium and Rhizoctonia solani. A total of 24 affected registered formulations from 21 companies including Syngenta and Sipcam are required to supplement field trial data.

The latest overhaul of China’s disinfection product regulation goes back as far as 2002, when all related technical matters were simultaneously compiled into the "Technical Standard for Disinfection (version 2002)". The 200-page document offered great value to authorities and testing institutes in assessing product quality, safety, and efficacy, the precondition for entering China's market. After years of regulatory reform, the premarketing surveillance of non-new disinfection products has been delegated to the health department at the provincial level, and regulatory studies can be conducted either by enterprises or third-party testing institutes (CMA-accredited). To improve compliance, help enterprises and testing facility comply and align with international practices, some of the product specifications, testing methods, and technical practice were revised, supplemented, and released in the form of national/industrial standards. Early this year, the Chinese Standardization Administration (SAC) announced seven disinfectant-related standards to be implemented on October 1. Two of these standards related to efficacy evaluation in the most common scenarios. This article explains the enforceability, product scope, and other elements affecting product qualification, etc. to keep overseas enterprises up-to-date with best practices. GB/T 38502-2020 Test Method of Bactericidal Effect of Disinfectant in laboratory GB/T 38504-2020 Evaluation Method of Disinfection Effect of Spray Disinfection PREMARKETING ASSESSMENT AND RECORDING FILING OF DISINFECTION PRODUCTS Currently, enterprises of Class I and Class II disinfection products need to complete a comprehensive evaluation on the product label, manual, test data, product standard/enterprise standard, hygienic license (homemade product)/documentary evidence & customs declaration (imported product), product formula(disinfectants, anti-microbial agents and sterilization indicators) or comp

On April 9th, 2020, the Chinese National Pesticide MRL Review Committee announced a government procurement program for pesticide MRL regulation development. Successful tenderers will be required to complete a series of MRL-related research and field trials within the next year.

On April 8th, 2020, China MoARA released a new draft regulation, explaining the target, mechanism, post-registration obligation, and criteria for a periodic and special re-evaluation of registered pesticides.

The Chinese Standardization Administration (SAC) has recently released the full content of 7 national standards regarding the toxicological study, storage stability test, efficacy evaluation and production management of disinfectants, all of which will be implemented on October 1, 2020.

On 23 March 2020, the Chinese Ministry of Agricultural and Rural Affairs released the Announcement 280 to designates 9 testing institutes for the regulatory study of pesticide products.

The Chinese Ministry of Agricultural and Rural Affairs consulted on March 18, 2020 a daft list of active ingredients of biopesticides registered in China. The list includes 47 microbial ingredients, 38 biochemical ingredients and 26 botanical ingredients, which help applicants to distinguish biopesticides from chemical pesticides, as well as the effective implementation of “fast-track” registration.