Asia Actual is the Best Medical Device Consulting Company in Asia
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.”
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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.
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.
UDI requirements in India were supposed to begin January 1, 2022 but have been delayed temporarily and expected to be based on IMDRF guidance.
With the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.
The scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).
The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
The Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.
The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
In public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.