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Impact Of Higher Duties On Local Mfg Of Medical Devices

When it comes to Medical Devices, taxation policies actually go towards its contradictory facet, though PM Narendra Modi has made ‘Make in India’ a boosting government area. Duties for device manufacture remain very high and that is the reason why device manufacture in India isn’t feasible. On the other hand, duties on finished goods have reasonably reduced. It is astonished that in some products such as Cardiac Stents, the duties have reduced to zero...

Medical Devices Industry Demands De-Listing Of Schedule M-III From Schedule M

The medical devices industry wants the government to de-list Schedule M-III from Schedule M stating that there is lot of ambiguity and confusion within the given requirements. They also insisted that to overcome and properly address the needs of the sector, the government should amend the existing Schedule M-III to comply with IS 15579/ISO 13485 quality management system requirements for regulatory purposes...

Health Ministry Amends D&C Rules To Make Labelling Mandatory For Medical Devices

In a significant move to regulate the mostly unregulated medical devices industry in the country, the Union health ministry has amended Rule 109A of the Drugs and Cosmetics Rules...

Ethylene Oxide Sterilization Standard: Newly Released

he ISO 11135 standard has provided manufacturers and health-care facilities with an outline for the establishment and validation of an EtO sterilization process for more than two decades. ISO 11135:2014 was published in July 2014 to replace ISO 11135-1:2007 and...