India’s Pollution Control Board (CPCB) has issued an update on plastic packaging and Plastic Waste Management (PWM) requiring importers quantify the type of plastics being imported through a brief registration process.
China is developing new standards and processes for the regulation of advertising for medical devices (as well as pharmaceuticals, food supplements and cosmetics). The goal is to maintain the order of the advertising market, standardize the review of advertisements and protect the rights and interests of consumers.
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.
The Department of Health (DH) in Hong Kong has announced a new strategy for the procurement of medical devices (MDs), effective from June 21, 2023.
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 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.
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- CDSCO Issues Updates to IVD Classification List in India November 29, 2023
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- Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS October 17, 2023
- India Grants Import License Grace Period for Class C/D Devices October 16, 2023
- Indonesia to Require Post-Market In-Country Testing of Medical Devices October 11, 2023
- China’s NMPA Updates Medical Device Classification Catalogue September 19, 2023
- Thai FDA Drafting New Guidance for SaMD and AI Device Registration September 18, 2023
- China NMPA Adds 47 Products to Clinical Trial Exemption List August 22, 2023
- New Plastic Waste (PWM) Rules Affect Medical Device Importers in India August 22, 2023
- China to Regulate Medical Device Advertising August 2, 2023