India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries
On 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.
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On 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.
Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
On 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.
The 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).
Prior 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.
Products approved under AMDD harmonized regulation with CSDT documentation are now eligible for an expedited review by the Philippines FDA.
Hong Kong’s Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.
Singapore’s Health Science Authority (HSA) to increase review fees in July 2022 by about 3%.
UDI requirements in India were supposed to begin January 1, 2022 but have been delayed temporarily and expected to be based on IMDRF guidance.
On January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately.