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.

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

30 Aug. 2021, CIRS signed a Strategic Cooperation Agreement with Aleph INDIA on BIS compliance service to help chemical and cosmetic manufacturers complete BIS certification. Bureau of Indian Standards, also known as BIS, is the National Standard Body of India established under the BIS Act 2016. BIS is responsible for the harmonious development of the activities of standardization, marking and quality certification of goods under the requirements of BIS Act 2016. The BIS cer

On April 16, 2021, the National Medical Products Administration released the "Guiding Principles for the Classification and Definition of Radio Frequency Beauty Products" for comments on the solicitation of "Guidelines for the Classification of Radio Frequency Beauty Products". According to the definition of the properties of the draft, it claims that radio frequency beauty can reduce spots and wrinkle. Such equipment is classified as medical device management. Medical devic

Adverse events (AE) refer to unfavorable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices. A serious adverse event (SAE) refers to a death or serious deterioration in health that occurs during a clinical trial, including fatal diseases or injuries, permanent defects in body structure or body function, requiring hospitalization or prolonged hospitalization, and the need to undergo Medical or surgical inte