A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
In a virtual meeting held June 19, 2023, the Thai Food and Drug Administration (TFDA) discussed several measures aimed at enhancing the management of medical device registration applications. Standing out was the new Regulatory Applicant (RA) program which provides expedited reviews to applications submitted by certified RA’s and the possibility of utilizing External Expert Bodies as an additional review resource.
Vietnam has recently made significant amendments to its medical device registration process and technical documentation requirements. The Ministry of Health (MOH) issued Circular 10/2023/TT-BY on May 11, 2023, outlining the new guidelines for pre-market approval.
On April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam.
On February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months.
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.
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