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China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.
In recent years, the government has made healthcare a priority for the 261 million Indonesians, providing a lot of potential for medical device manufacturers of all technology levels. The government has also taken numerous steps to curb corruption through their online e-catalogue and other methods which has helped bring in more foreign companies and investment.
With effect from December 1, 2020, India power cords, cord sets, plugs and sockets must carry the Mark of Conformity (product approval mark) which has been established by the Central Government of India through the Bureau of Indian Standards (BIS) Act (2016), BIS Rules 2018, and BIS Conformity Assessment Regulations (2018).
The South Korean regulator, the Ministry of Food and Drug Safety (MDFS), recently released multiple guidance documents related to software using AI, Big Data and Machine Learning.
All formerly unregulated medical devices are now being transitioned to require registration in India under the Medical Device Rules, 2017. These products should be Registered prior to October 1, 2021 and then obtain an Import License before October 1, 2022, or October 1, 2023 depending on the product’s risk classification.
All IVD related equipment, instruments and software is now being transitioned to require registration in India under the Medical Device Rules, 2017, joining IVD reagents and kits which have been regulated since January 1, 2018, if not before.
As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.
Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.
The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China
The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.