Medical Device Rules 2017 - Decoding the Impact (Mumbai)
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
Lead Pharma & Healthcare Practice
Nishith Desai Associates
Dr. Milind Antani leads Pharma & Healthcare practice at multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi, Mumbai – BKC, Munich and New York. He also leads Social Sector Practice.
He represents clients in JVs, MnAs, VC and Private Equity investments, Collaborations, Regulatory advice, IP, Licensing and Commercialization matters. He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS. He is a regular speaker and panelist at various national and international forums on the subjects of pharma, Medical Device, biotech, IP, clinical trials, healthcare, CSR and e Health. He is also a visiting faculty at many institutions in Mumbai and Gujarat.
He is also recipient of certificate on “Managing and Transforming Professional Service Firms-India” an executive program organized by HARVARD BUSINESS SCHOOL. He has been included as one of the world`s leading practitioners in ‘Who`s Who Legal’ for Life Sciences 2014, 2015, 2016, 2017 and 2018 in the ‘Regulatory’ section as the only lawyer from India.
He has had his career as an ENT surgeon in Anand, Gujarat for 14 years before he changed career to law and moved to Mumbai 14 years ago.
Krishnamurthy & Co.
Arunabh Choudhary is a Partner at Juris Corp. His practice portfolio encompasses Securities Markets, Commercial Laws, Private Equity transactions, Taxation, Competition Law, Policy Advisory and Tech Law. He caters to diverse national and international clients including corporates, commercial banks, investment banks, funds as well as start-ups. He has advised organizations registered with multiple regulators viz. SEBI, RBI and IRDAI. He also represents and advises the Competition Commission of India (CCI), and deals in complex matters faced by emerging FinTech entities, including aggregators.
Illustrative important matters handled
- Advising a Mumbai based company on issues relating to the Medical Councilof India Guidelines (“MCI Guidelines”), Indian Council of Medical Research Guidelines, Information Technology Act, and Maharashtra Medical Council Guidelines. We are also involved in advising the company on their business model which requires collection of data and using it for big data analytics from the perspective of MCI Guidelines and privacy issues.
- Conducting presentation in relation to “Medical Negligence issues pertaining to healthcare industries” on behest of a Pharma MNC for doctors across India
- Advising and obtaining registration for Delhi NCR based company in relation to import and assembling of medical devises into India
- Advising and representing the Competition Commission of India (“CCI”) in a matter of bid-rigging against some of the top pharma companies
- Advising a Bangalore based start-up which is involved in creating online aggregator platforms for medical services and equipment’s
- Advising on a funding transaction for a bid by an Indian healthcare group for a Singapore listed hospital company.
International Airport Approach Road, Next to Leela, Marol, Andheri (E), Mumbai
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