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Guideline on Market Access for Medical Device in China is a report drafted by CIRS Group- Medical Device BU to help companies and individuals who would like to sell their medical devices to the People’s Republic of China and get their medical device products registered with NMPA. The guide describes key definitions, main regulations, authorities of the medical devices in China, and also the requirements of the whole life-cycle of medical devices including pre-registration preparatioin, registration process, testing/inspection, clinical evaluation, QMS and post-market management.
On August 31, 2022, CIRS Korea registered as an environmental consulting company under the Environmental Technology and Industry Support Act After registering, CIRS Korea may receive preferential access to the environmental policies and other relevant information, making it possible for CIRS Korea to better provide chemical, cosmetics, and environmental consulting services to clients.
Since its establishment in 2007, CIRS Group has focused on product regulatory compliance services, helping clients gain a competitive advantage by reducing business risks associated with regulatory affairs. After 15 years of development, CIRS Group has expanded its business across multiple industries to include: chemicals, cosmetics, food and beverages, medical devices, agrochemical products, disinfectants, and consumer goods.
3 Jun. 2022, CIRS Group Korea Co., Ltd. (CIRS Korea) formally got certified to the ISO Certification for its compliance with the requirements of Quality Management System ISO 9001:2015 and ISO 14001:2015 Environmental Management System. The scope of supply cover: Regulations compliance on domestic and foreign Chemicals/ Cosmetics/ Foods/ Medical Devices and KS /KC /JIS /ISO standard certification consulting
CIRS Group has reached a cooperation agreement with leading agrochemical CRO SynTech Research Group. SynTech Research Group provides a full range of contract efficacy, environmental, regulatory and market support services, to agrochemical, bio-stimulant and biocontrol sector with strong presences in Europe and Americas.
The overview of medical device regulatory activities in 2021 The data analysis of medical device registration in 2021 Summary of medical device regulation updates in 2021 The new medical device rules in 2022
CIRS Group Certificates & Reports Verification System is developed to verify the authenticity and validity of all the certificates and reports issued by CIRS Group that are communicated throughout the supply chain. With this system, enterprises will also obtain compliance recommendations as well as customer services.
CIRS Korea is selected as the organizer of the "Pilot Project for the Analysis of Active Substance" promoted by the Ministry of Environment in South Korea. Under this pilot project, MoE will elect five substances with high difficulty in analyzing applied by SMEs and carry out qualitative and quantitative tests on the principal components and impurities containing over 0.1% of these five substances under the requirements of Act on Safety Management of Household Chemical Produ
On 19 Oct. 2021, CIRS Korea was granted the “Excellent Enterprise in Environmental Industry by the Ministry of Environment. The Ministry of Environment was originated from the Ministry of Health and Welfare established in 1967 and was renamed Ministry of Environment in 1994. It is one of the most authoritative administrative organs in South Korea, which mainly responsible for protecting the natural environment and living environment, avoiding the threat of various environm
Free Webinar-Overview of Chinese Medical Device Regulations-Korea Branch
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