TOPRA in India: Medical Device Registration in India

TOPRA in India: Medical Device Registration in India
TOPRA in India welcomes you to our webinar presentation: Registration Pathway for Medical Devices in India.






Date: Tuesday 3 October 2023
Time: 10:30-11:30 BST / 11:30-12:30 CET / 15:00-16:00 IST


This webinar will cover a high-level Registration Pathways, Classification, Data requirements, Registration Process, Price Control and Materiovigilance programme for Medical Devices in India. This webinar will be helpful for the organizations planning to Register Medical Devices in India for the first time and a refresher for the experienced organizations.

Our guest speakers:

Anoop Kumar Mishra holds a Postgraduate degree in Pharmaceutical Sciences with over 18 years of Regulatory Strategy, operations, compliance and Government Affairs experience across categories of Pharmaceuticals, Medical Devices, Cosmetics, Biocides, Nutraceuticals and Home care product categories for India, South Asia and Emerging Markets. Currently he is handling role of Regional Director, Regulatory Affairs & Safety, South Asia at Reckitt Benckiser (India) Pvt. Ltd.   Prior to this role, he has worked with Glenmark, Menarini, Ranbaxy (now Sun Pharmaceuticals Ltd) and Unichem Laboratories Ltd. 

He started his early carrier as R&D scientist developing medicinal products and later joined in regulatory affairs managing emerging markets for Pharmaceuticals and OTC categories.   Anoop is a member of TOPRA and member of Regulatory Committee in various trade associations i.e., FICCI, IHPCIA, HICA and WeCare on driving policy advocacy and sustainability. 

Parveen Jain holds a Postgraduate degree in Pharmacy, with over 13 years of Regulatory Affairs experience in Pharmaceutical, FMCG, and Medical Device profile. Currently he is handling role of Senior Director, Quality and Regulatory Affair, Asia Pacific, Fresenius Medical Care.   Prior to this role, he has served as Head- of Regulatory Affairs, Quality, and Government Affairs at Fresenius Medical Care (India). He proudly holds different honorary government and Industry trade positions.   He is an Expert Member, Biological & rDNA Committee- Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Co-Chair- NatHealth, Chair-India Regulatory Affairs in APACMed, and Chair- ISCR. He is RAPS Board Certified Regulatory Affairs Professional in Global Medical Devices. 
 
ShivKumar Hurdale holds a Postgraduate degree in Pharmaceutical Technology with over 20 years of RA,QA and Government Affairs experience in Pharmaceutical, FMCG and Medical Device profile South Asia, APAC and USA region. Currently he is handling role of Senior Director, Regulatory Affairs & Quality Assurance, Asia Pacific, Stryker Pvt Ltd.  Shivkumar is a certified ISO 13485:2016 Lead Auditor and has completed Global Internationally Certified course in EU Medical Device Regulation (2017/745) and MEDDEV 2.7/1 rev.4 by Oriel STAT A MATRIX, New Jersey, USA. Shiv has also successfully completed PG Diploma in Leadership Management form Thomas International, USA and CDS Institute, Bangalore.  Shivkumar has worked with Johnson & Johnson, Medtronic, Abbott, and Novartis Healthcare. Shiv also represents Govt of India (BIS) in ISO TC/150 Committee.
 
He is currently Chair of Regulatory Intelligence Committee of APACMed (Asia Pacific Medical Technology Association, Singapore), and has Chaired and Co-Chaired Regulatory and Advocacy Sub-committees of Medical Devices in CII, FICCI, MTaI. 
 

Pricing
  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

 

How to register

Members:

  • Use the 'Register now' form above to log in to the site with your TOPRA Member username and password.
  • Once logged in click the 'Register Myself' button that will appear below.

Non-members:

  • If you already have non-member account for this site, log in and then click the 'Register Myself' link that will appear below.
  • If you do not have an account, create an account, then log in and click the 'Register Myself' link that will appear below.
 
When
03/10/2023 10:30 - 11:30
Where
ONLINE
Registration is closed.
My registration status: Not registered
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

Register now