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..

The Medical Device Control Division of the Thailand Food and Drug Administration (Thai FDA) has recognized the Singapore Health Sciences Authority (HSA) as a reference regulatory agency. The Thai FDA and Singapore HSA have agreed to collaborate to expedite the registration process of medical devices through a Regulatory Reliance Program. Participation is possible if you are a medical device regi..

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..

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices. Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK..

ANVISA, Brazil's medical device regulator, issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Declaration and Registration of Medical Devices, the amendment effective August 18, 2023. The revised content allows the import of medical devices and accessories if the manufacturing date is earlier than the date of declaration or registration. Note that the period between the manufacturi..

With the development of information and communication technology, the number of wired and wireless communication medical devices is increasing. As a result, cases of cybersecurity threats such as hacking and information leakage are steadily increasing. For this reason, the application of cybersecurity in medical devices has been strengthened because it can directly harm patient life. Medical dev..