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- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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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.
Philippines FDA to Expedite Applications Approved Under AMDD-CSDT
/in Latest Updates, Philippines/by Charmaine RosonProducts approved under AMDD harmonized regulation with CSDT documentation are now eligible for an expedited review by the Philippines FDA.