A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.
The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.
Learn about the recent Virtual Regional Workshop on Good Regulatory Practices and Medical Device Regulation hosted by USAID, ANSI, and AdvaMed. Attendees gained valuable knowledge on navigating the complex world of medical device regulation, including discussions on specific GRPS, WHO global model regulatory framework updates, and country experiences with reliance models. Read on to discover the benefits of recognizing foreign conformity assessment results, transparency, predictability, inclusion, consistency, and accountability.
Get the latest insights on the Specialist Review Guidance for medical device registration in Thailand from the Thai FDA. Learn about the criteria that trigger a Specialist Review and how to potentially avoid it.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
On April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.
On February 11th and 14th, the Ministry of Health of the Republic of Indonesia implemented significant structural and procedural changes to the government procurement system known as e-Catalogue as it applies to medical devices (reference announcement KN.01.04/3/630/2022). Under the new rules, oversight of the e-Catalogue has been moved under the Ministry of Health and will not require negotiations.
On July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,
Hong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.
In 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country.
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