Medical Device Rules 2017 - Decoding the Impact (Gurgaon)
India is one of the largest markets for medical devices in the world which is largely dominated by imported products. The domestic companies are largely involved in manufacturing consumables and low-end products for local and as well as international consumption. The Government in order to promote research, development and manufacturing of medical devices in India have taken steps like permitting 100% FDI in the medical devices sector and correction of the inverted duty structure for certain medical devices. But the India Medical Device industry has largely been unregulated till now. But now the government has introduced Medical Devices Rules, 2017 to bring the entire industry under the regulatory framework. The Devices Rules were notified under the Drugs and Cosmetics Act, 1940 ("Drugs Act") on 31 January 2017 and are proposed to come into effect on and from 1 January 2018.
CorpKonnect is organizing is a full day training program on the Medical Device Rules to understand the new rules, changes from the current situation and it’s impact on business at large.
Format on the Program and Deliverables to the Participants:
- Each session would be presented by a different expert
- These sessions would be interactive sessions with Questions and Answers and discussion with the experts during the sessions itself
- A booklet with literature of the program would be provided to the participants at the venue on the date of the training
- After the training, the presentations of all the experts would be provided in soft copy to all the participants through email
- Participation Certificate at the end of the program
Technical Session 1: Current Regulatory Scenario Vs. the New Rules – A Risk Based Approach
- Definition of Medical Devices
- Classification and Licenses
- Licence, permission and registration certificate
- Labelling and Shelf Life
- Documents to be submitted for registration of Notified Body, its duties and functions
- Documents to be furnished along with application in Form MD1
- Duties and functions of Notified Body
- Audit Procedure
- Documents required for grant of manufacturing and import licence
- Quality Management System for notified medical devices and IVD
What these Changes Mean to You and Your Business?
Technical Session 2: Other Focus Areas (Current vs The New Rules)
- Major and Minor changes Post Change in Licensed Particulars
- Requirements for permission to conduct clinical investigation
- Requirement of Product Recalls
- Residual shelf life of imported products
- Change in constitution
Analysing the Action Points and Business Impact
Price Control for Medical Devices
Technical Session 3: New Compliance Requirements and assessing the impact on:
- License for sale of medical devices
- Post Grant Compliances
- Import of Medical Devices
- Export of Medical Devices
- Debarment on account of supply of misleading information
Steps Ahead for existing importers, manufacturers and distributors?
Assessing Business Impact and Devising Action Points:
- Analysing the Short Term and Long Term impact of the New Rules
- Aligning business operations
- New labelling requirements
- Guidelines on essential principles of safety and performance
Key Issues and Challenges Ahead
J. Sagar Associates
Shantanu’s practice covers diverse areas of Corporate Commercial, Corporate Restructuring, Mergers & Acquisitions and Private Equity investments.
He has been representing multi-national companies in various cross-border transactions, advising on foreign direct investments, outbound investments, joint ventures, technology transfers and commercial contract issues.
His work experience includes advising Indian and foreign parties on Private Equity investments in India, and on various issues arising out of the exchange control laws, Companies Act, and sector specific laws.
Prior to joining JSA, Shantanu has had the experience of practising before the Hon’ble Supreme Court of India and the Hon’ble High Court of Delhi.
Sr. Consultant (Healthcare, Medical Devices & Pharmaceuticals)
Rakesh Sharma is a Senior Consultant with Lex Favios in the Healthcare, Medical Devices & Pharmaceuticals practice. Mr. Rakesh Sharma is a leading expert in the field of Government and Regulatory affairs. He has a wide-ranging leadership experience of over 30 years with Fortune 500 companies like (Becton Dickinson India Gillette India) covering a broad spectrum of consultancy assignments in the field of Regulatory Affairs, Government Affairs, Supply Chain Management, Public Policy Imports /Exports, Logistics, Procurement etc.
Mr. Sharma has in-depth understanding of Drug and Pharmaceutical laws. He has been associated with Ministry of Health / Office of Drug Controller General of India, Consumer Affairs Ministry, Finance Ministry, Bureau of Indian Standards, Ministry of Science & Technology.
Vaish Associates Advocates
Abhijeet Das is a Senior Associate with Vaish Associates Advocates with eight years of experience, inter alia assisting/representing a broad spectrum of domestic and foreign clients on Indian corporate laws including vis-à-vis private equity transactions. His practice also includes assistance concerning securing and protection of intellectual property rights and providing transactional guidance on a diverse range of intellectual property assignment and licensing arrangements.
Over the years he has carved a nich in the Life Sciences and Healthcare sphere, which includes the legal and regulatory issues pertaining to clinical trials; advising various pharmaceutical companies, clinical research organizations, healthcare institutions and notable ethics committees on the niceties of the sector.
Some of his publications in the field are illustrated below:
- Co-authored an article published in ‘Express Healthcare’ (a Financial Express publication) Vol. 11, No. 6, June 2017 India’s Foremost Healthcare Magazine (Indian Express), titled, “The Medical Devices Rules, 2017 – Industry Implications and Action Required”;
- Authored an article published in ‘Express Pharma’ (a Financial Express publication), titled, “DCG(I) bans 344 drugs constituting fixed dose combinations, but will it hold?” dated March 21, 2016;
- Co-authored an article published in ‘Express Pharma’ (a Financial Express publication) Vol. 10, No. 5, 01-15, January 2015, titled, “Clinical research in 2015: The ghost of Christmas past, present and yet to come”; and
- Co-authored an article published in ‘The Hindu – Business Line’, titled, “Clinical trial research is no crime”, dated December 1, 2014.
Vaish Associates Advocates
Hitender Mehta is a senior member of the Corporate practice of the Firm at New Delhi and has been associated with the Firm since 2005. He is also a qualified Chartered Accountant and Company Secretary. He specializes in SEZs, limited liability partnerships, mergers & acquisitions, restructuring of business, asset & share purchase deals, takeovers and general corporate advisory. He also has a wide range of experience in cross-border business transactions, private equity, joint ventures and strategic alliances.
He is a frequent speaker at various national and international conferences and seminars organized by leading professional bodies and chambers on subjects like Companies Act, Limited Liability Partnerships, SEZs, Foreign Direct Investment, M&A, Takeover Code and Joint Ventures and other topical issues. He has also authored various articles and publications including books titled “Limited Liability Partnerships –Law and Practice” published by Wolters Kluwer India and “Law & Practice relating to Special Economic Zones” published by Taxmann. He has been the past Chairman of Northern India Regional Council (NIRC) of the Institute of Company Secretaries of India (ICSI); Member, National Council on Banking and Finance, ASSOCHAM; Member, National Council on Indirect Tax, ASSOCHAM; Member, Foreign Trade & Investment Committee, PHDCCI; Member, Corporate Affairs Committee, PHDCCI; Member, Advisory Board, National Law University, Jodhpu
J. Sagar Associates
Srikant is part of the corporate M&A practice group of JSA and has assisted various domestic and international clients in various M&A transactions. Srikant’s work experience includes advising Indian and foreign clients on various issues arising out of the exchange control laws, Companies Act, franchising and brand licensing space, financial services sector. Srikant has done transactions in various sectors including medical devices, consumer retail, renewable energy, franchising, financial services etc. Some of the recent transactions in which Srikant has been involved in include: (a) the acquisition of Tulip Group by PerkinElmer, which was one of the biggest deals in the medical devices space; (b) Grupo Bimbo’s majority acquisition of Harvest Gold breads; (c) the acquisition of Freecharge by Axis Bank from Snapdeal.
42, Golf Course Road, DLF Phase V, Sector 43, Gurugram, Haryana 122002
Registration Fees: INR 10,000 + 18% GST Per Delegate
Avail 10% early bird discount on 2 or more registrations till 5th Dec 2017
Note: The fees would include Course Material, Participation Certificate and Lunch & Refreshments at the Hotel
Modes of Payment and Registration:
For registration through Credit/Debit Card, Cheque/DD and NEFT: Please contact the below mentioned:
Mob No: 8130826342