Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.
On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.
On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect. A translated version of the document is available on Asia Actual’s website here. All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.
On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2023-DC (344), granting a grace period for Import Licenses to qualifying Non-Regulatory Class C and D medical devices.
China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.
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.
The Thai government has voiced their commitment to ending the epidemic by supporting preventative awareness, access to cost-effective tests and treatment resources through public investment and/or private partnerships.
Uncertainty. If there is one word that best describes the global outlook during the 2020 pandemic this might be one that everyone can agree on.
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