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.
A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
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.
In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.
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 June 1, 2022, the TFDA released an announcement outlining the expansion of the Singapore Reliance Route program. This allows manufacturers with Singapore approvals that used CSDT documentation to cut their review time down to 60 working days.
On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.
In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.
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.