Maharashtra FDA Warns 100 MD Officers For Implementation of New MD Rules – ZMR Blog
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Maharashtra FDA Warns 100 MD Officers For Implementation of New MD Rules

The Food and Drug Administration (FDA) of Maharashtra has notified about 100 Medical Device (MD) officers, seven Assistant Commissioners, and seven Joint Commissioners to implement the MD rules 2017. This notification has come in quick succession of the appointment of notified bodies at Central Drugs Standard Control Organization (CDSCO).

Maharashtra FDA Warns 100 MD Officers For Implementation of New MD Rules

The MD rules 2017 were issued last year. These rules came in to effect from January 1, 2018. CDSCO notified and appointed Intertek India and TUV Rheinland India to implement the new MD rules. These two companies will have to audit all the manufacturing sites to comply the MD rules 2017.

The manufactures will have to follow strict quality management system while manufacturing all medical devices in order to implement the new MD rule. It covers the manufacturing of medical devices, in-vitro diagnostics (IVDs), surgical sutures, condoms, bandages, and disinfectants. It is proclaimed that the new law will set the new standards for manufacturing as well as utilization of medical devices.

CDSCO had recently launched the SUGAM portal, which is an online service. It helps in importing, manufacture, clinical investigation, and sales & distribution licenses of medical devices through a single window.

Amrut Nikhade, Joint Commissioner, Maharashtra FDA, proclaimed that the notified officers are provided with the individual user id and passwords. The centralized online service SUGAM portal will help in effective implementation of the new rules. Also, he assured that it will be beneficial for both MD officers as well as manufacturers.

On a similar note, the FDA has recently proposed for the mandatory registration of all the shops selling Ayurvedic drugs. Nitin Deore, Assistant Commissioner (Drugs), FDA, asserted that the organization has sent a proposal to the government for the same. Further, he proclaimed that the move is focused on bringing in the standardization and put a check on adulteration of Ayurvedic medicines.

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