Invoicing Requirements for Medical Device Software in India
India is considered a high tax environment with complex requirements, with tax law being in a state of constant change. For those concerned with SaMD invoicing, the process may be complex.
Gunjan Verma is a Managing Partner at Asia Actual India, based in Gurgaon (National Capital Region – NCR), India. Previously, Gunjan was the Director- Regulatory Affairs and Quality Assurance at Zimmer Biomet India.
She holds a Bachelor’s Degree in Pharmacy from the Delhi Institute of Pharmaceutical Sciences and Research, Delhi University and completed her Post Graduate Degree in Pharmaceutics from the same institute. She also holds a Masters Diploma in Business Administration from Symbiosis Institute of Distance Learning, specializing in International Business. Starting at Win-Medicare Limited in year 1999, she moved through various assignments with increasing responsibilities at Baxter, Reckitt Benckiser and Zimmer Biomet. Her key area of interest is Regulatory Affairs and Commercial Quality Assurance for Medical Devices, In-vitro Diagnostics, Pharmaceuticals, Combination Products, Cosmetics, and Consumer goods.
In her previous assignments, Gunjan has led Regulatory Affairs, Quality Assurance, Advocacy and Policy Development initiatives as well as held additional responsibility for Integrity and Compliance facilitating the rollout of compliance initiatives and process changes, formulating new strategies for specific issues and negotiating resolutions. She is active in advocacy and engagement initiatives through industry bodies and is an author in the Boston Consulting Group (BCG) – Confederation of Indian Industry (CII) Report 2014 – Medical Technology Vision 2025 – A $50 Billion Opportunity for India. She is also a contributor to the BCG-CII Vision Report 2015 – The $50 Billion Opportunity – Making it happen for India.
India is considered a high tax environment with complex requirements, with tax law being in a state of constant change. For those concerned with SaMD invoicing, the process may be complex.
On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.
With effect from December 1, 2020, India power cords, cord sets, plugs and sockets must carry the Mark of Conformity (product approval mark) which has been established by the Central Government of India through the Bureau of Indian Standards (BIS) Act (2016), BIS Rules 2018, and BIS Conformity Assessment Regulations (2018).
All formerly unregulated medical devices are now being transitioned to require registration in India under the Medical Device Rules, 2017. These products should be Registered prior to October 1, 2021 and then obtain an Import License before October 1, 2022, or October 1, 2023 depending on the product’s risk classification.
All IVD related equipment, instruments and software is now being transitioned to require registration in India under the Medical Device Rules, 2017, joining IVD reagents and kits which have been regulated since January 1, 2018, if not before.
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