|
SIIC
IIT KANPUR In Collaboration With Medical Device Industry
Leaders, Associations & Institutions
Creating Ecosystem To Support MedTech Start-Ups & SMEs.
Organized Webinar Series
Highlights Of Discussions During
Webinars
Webinar 1: Awaiting India to take
the Lead: Prospects & Challenges of MedTech Industry
-
Brief about the current Medical Devices Industry profile
for the FY 2020-21 especially highlighting the high
percentage of imported devices in the country.
-
Key challenges which are faced by entrepreneurs and the
hospitals include , lack of access to accurate data
(including the definition of the target price, import
price, and MRP), costing: competition with low priced,
pre-commercial medical electronics import, tariff policy,
clinical evaluation, limited access to plug & play
facility or Land or built-up infrastructure, quality
credibility, tender seeking US FDA/CE overseas regulatory
approval, discriminatory regulations that put
manufacturers at a disadvantage, tenders seeking matching
of non-remunerative L1 prices of China.
-
Awareness was spread regarding the unethical marketing
practices of some MNC’s directly or through their
distributors. Issues at hand like lack of Indigenous
Benchmark studies by Institutes of Indian Devices to prove
competitiveness and cost -effectiveness and restrictive
trade practices were also put forward.
Webinar 2: Medical Devices Rules
2017 & Role of Notified bodies in medical devices
regulations
-
Brief history and evolution of the Medical Devices
Regulatory framework of the country including the Drugs &
Cosmetics Act, 1940 and its importance in the medical
regulatory framework. The entire landscape of Indian
Regulatory Framework starting from Legislation to
retail/distribution license concerning the CDSCO/DCG(I)
and/or State FDA was covered.
-
The list of devices notified by the Govt of India.
-
The salient features of MDR 2017, the broad Standards of
medical devices, and the process to abide by them in a
chronological process.
-
Steps involved in medical device QMS Compliance : Fifth
Schedule-IMDR, 2017, and the dimensions covered under
itand the process approach or the complete cycle that
links the regulatory authorities
ISO 13485 (user needs) to Products & Services.
The common non-conformities
issued, the mandatory documented procedure under the 5th
Schedule, IQA and MRM related
concerns, and also the Inadequate control on suppliers and
clean rooms. Issues related to
Insufficient Design documents and
consolidated steps for small organizations to
have successful audit.
Webinar 3: BIS Standards for Medical Devices and
Services by NABL Labs
-
The activities done by the BIS starting from Standards
Formulations to Training Services on National &
International Level and listed the medical device rules in
Clause 7 product standards for medical devices and the
ongoing projects (Priority Assistive Devices) with the
current challenges in standardization and briefly touching
on the new initiatives taken by BIS. Some light was thrown
into the Conformity Assessment Schemes (CAS) based on
their type and scope.
-
List of the benefits of NABL Accredited Laboratories and
the accreditation for Calibration of Medical Equipment.
Also, the NABL Symbolizations in Test Reports and
Calibration Certificates.
Webinar 4: ICMED Schemes & Nuances
of CE Certification for Medical Devices
-
The broad classification of ICMED Certification, the
registration process including the Audit process and
Maintaining Certification. Various ICMED Schemes such as
ICMED 9000, ICMED 13485 and the recently launched ICMED
13485 Plus were presented in detail.
-
The entire approval process of Certification Body for
ICMED Certification, starting from the submission of
application to the decision of QCI on Provisional Approval
of CB along with the rules for use of Certification Mark
and the Current Status- ICMED were also briefly presented.
-
Requirements of CE marking and the brief about the
evolution of MDR subsequently the new regulatory
framework, key changes related to scope and classification
of the product, etc., and lastly the technical
documentation. Most of the clarifications regarding the
difference between Directive and Regulation were carried
out.
-
The Conformity Assessment concerning Annexure VIII, IX, X
and XI and the key changes in Articles (articles
27,18,2,55,61) were also discussed. Lastly, the European
Databank on Medical Device was described in terms of its
pillars which constitute varied electronic systems on
Registration, UDI, Certificates, Vigilance, Market
Surveillance, and Clinical Investigations.
Webinar 5: Ask Us Anything on
Complying with Domestic Regulations for Medical Devices
-
The timelines of certifications according to the varied
groups of devices in the medical Industry and Quality
Management and Quality Control mythology.
-
Reasons for having regulations in the Medical Devices
Industry and how one can scale up their business in the
international market.
-
Plethora of knowledge about the certified schemes operated
by BIS as of now.
-
Experiences of challenges that an entrepreneur faced
during his building phase.
-
Webinar 6: Ask Us Anything on
international acceptability of Indian medical devices.
-
The International Acceptability of Standards and steps to
comply with the standard and overview on ICMED and its
components i.e., Level I, II, and III and how NABCB is
assisting the next generation startups for global
acceptance.
-
Virtual tour of AMTZ and the aspects of manufacturing a
good quality Medical Device and the five basic standards
i.e., ISO 14971, ISO 15223, EN 1041, ISO 10993, and
Management System Standard 13485.
-
Experience shared by the entrepreneur during the
building-up of NOCCARC.
|
