India CDSCO introduced the Medical Device Rules (Medical Device Rules, 2017), Items subject to medical device registration have been expanded, and online applications for medical devices (SUGAM) have become mandatory. In order to enter the Indian medical device market, it is essential to check whether registration is required and the product risk level through the classification table. According..

The European Medical Device Management System has been upgraded from Directive MDD(Directive 93/42/EEC for Medical device) to Regulation MDR(Medical Device Regulation (EU) 2017/745). With the introduction of higher regulation MDR, Companies that have undertaken the work of certification bodies with existing MDD NBs should be re-evaluated by enhanced European authorities on NBs' designation crite..

China medical industry is still growing rapidly. As of 2022, the Chinese medical device market was 1.3 trillion yuan, growing 6.1 in size compared to 2013. The Chinese medical device market has a global market share of 27.5%, with an average annual growth rate of more than 12% over the past five years. China is a market that cannot be abandoned despite its policy of using domestic medical device..

China's National Medicines Agency (NMPA) has announced amendments to its catalog to classify medical devices. Manufacturers need a lot of attention because the amendment affects the cost and time of medical device registration. The 56 changes announced include adding new products, changing descriptions of some devices, and changing some device classifications. We inform you of the major revision..

Indonesia is the third country to implement the AMDD standard, following Singapore and Malaysia. Indonesia is classified into Class A, Class B, Class C, and Class D according to risk, and product groups are broadly classified into five categories. · Radiation electromedical devices · Non-radiation electromedical devices · Sterile non-electromedical devices · Non-sterile non-electromedical device..

The European Medical Device Regulations (Regulation 2017/745, MDR) require that each particular device model has its own UDI-DI. Contact lenses vary widely, requiring the manufacturer to specify a number of UDI-DI. The EC adopted this mandate out of concern that a higher number of UDI-DI would lead to a surge in medical device registrations in EUDAMED. The amendment takes effect on November 9, 2..

Medical devices and in vitro diagnostic medical devices in Mexico comply with the Mexico standard NOM-241-SSA1-2021. Mexico is classified into Class I, Class II, and Class III depending on risk, and all medical devices and in vitro diagnostic medical devices must be registered mandatory sanitary registration. The regulatory authorities related to medical devices and in vitro diagnostic medical d..

There was a national shutdown at ICASA offices from September 27, 2023, which have negatively influenced on delivery of Type Approval Certificates. The strike has been ended on October 10, 2023, but the 2 weeks shutdown may still cause the delay on Type Approval because of workload issues.

MIIT issued a notice about IPv6 test on WLAN devices for SRRC approval on October 13, 2023. The key points to focus on are as follows: 1. Wireless LAN devices with public IP address allocation function should support the IPv6 protocol. 2. IPv6 wireless LAN devices should support and enable IPv6 address allocation function by default, while retaining the option for users to configure IPv6 address..