*Out now in the JMDR Digital Bookstore*:
Learn all bout the Korean regulatory framework for medical devices in
‘An overview of the regulatory requirements for medical devices in the Republic of Korea’
*Sneak Preview: In the upcoming JMDR November 2024 issue*:
Unlock insights on China’s regulatory landscape in our exclusive interview with
‘Katherine Wang on the important new draft ‘Medical Device Administrative Law
*Sneak Preview: In the upcoming JMDR November 2024* issue:
Discover key insights and actionable guidance in
‘An Analysis of the EU MDCG Recommendations on Clinical Investigation Plans and Investigator’s Brochures’
*Regulatory News from
⏰ Malaysia: Companies are strongly advised to submit re-registration of medical devices one year before certificate expiry
Subscribe now to read the full story.
*Regulatory News from Israel:
🚀Fast-track registration process launched for class II devices and medium risk IVDs
Subscribe now to read the full story!
*Regulatory News from China:
📒Are you aware of the new IVD reagent “Classification Catalogue” that will become effective in January 2025?
Subscribe now to read the full story!
🌻OUT NOW in the JMDR Bookstore:
🌻Medical device regulation in a changing world of sustainability awareness
🌻the evolving regulatory landscape
🌻the increasing awareness of sustainability
🌻how companies are adapting
🌻and what the future holds.
https://t.co/agqjZupCUR
🔎 OUT NOW in the JMDR Bookstore:
🔎 A tabulated summary of the UDI requirements for Australia, Brazil, China, Egypt, the European Union, India, Korea (Republic of), Malaysia, Saudi Arabia, Singapore, Taiwan, Turkey and the USA.
Includes hyperlinks to the legislation.
💥Out Now in the JMDR Bookstore:
💥PMDA overview of the review systems for innovative medical devices in Japan
💥Are you responsible for medical device approval in Japan?
Then you should read this overview of the newly enforced systems for innovative device review.