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- Key Takeaways from VietNam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
- Indonesia Invests in Quality Healthcare Access May 22, 2024
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Thai FDA Updates List of Chemical Pollutants
/in Latest Updates, Thailand/by Bryan GilburgThe TFDA has updated their list of chemical pollutants to comply with the Stockholm Convention on Persistent Organic Pollutants.
Indonesia Revamps eCatalogue Procurement System
/in Indonesia, Latest Updates/by Ilham HidayattulahOn 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.
India’s CDSCO Expected to Begin Enforcing Local BIS Standards
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.
India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.
Asia Actual is the Best Medical Device Consulting Company in Asia
/in Australia, China, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Todd DaigneaultManufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
India’s MOH Releases Draft Amendment to the Medical Device Rules 2017
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.
Philippines FDA Issues New Draft IVD Regulations
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA released new draft IVD guidance for the public’s review and comment in early January 2022 which would harmonize their regulations with the ASEAN Medical Devices Directive (AMDD).
India’s CDSCO Releases Draft Notice for Suspending or Cancelling Import Licenses
/in India, Latest Updates/by Gunjan VermaPrior to this draft notification, there was no explicit rule providing clarity about the cancellation or suspension regarding the import License in case of any violation of the conditions by the license holder while such provisions were included for a manufacturing license in the MDR 2017.