Compiled by
Mrs. Rama Venugopal,
President,
Consultants Consortium Of Chennai

Day 4 Webinar was created for Medical Device Industry on Standards, Certifications and Regulations. The Session was scheduled on Dec 17th from 4 – 6 pm and was attended by Med Dev Industry players and various stakeholders of the industry.

Program started off with opening remarks by Dr Usha Jain and Shri D L Pandya, Expo Organisers and thereafter was moderated by Dr Sanjeev Kumar Gupta and Mrs Rama Venugopal from Consultants Consortium of Chennai, the Conference Organisers.

Key Note Address By

Dr. Ravikant Sharma
Deputy Drug Controller, CDSCO

“Towards a World Class Regime”

Session started off with a key note speech Dr Ravi Kant Sharma, DDC, CDSCO.

Dr Sharma briefed the industry about commitment shown by CDSCO in issuing licenses to the industry even during covid times in about a week’s time to all applicants. CDSCO is committee to work along with the industry to make industry focus on making India Self Reliant in med dev mfrg space. He mentioned that CDSCO currently is regulating only 24 categories of medical devices and all med dev come under Regulation as per the mandate of MoH&FW. Currently , the Regulator has only called for Voluntary Registration of all Med Dev in the country as to understand who is manufacturing what products in the country ! This is purely a voluntary registration process before mandatory licensing kick starts. Industry is currently under transition phase towards a regulatory regime. Dr Sharma has explained that Class A and B devices are given a 12 + 18 months timeline before they come under licensing regime & Class C and D devices are given a 42 months timeline to be ready before mandatory licensing starts. He also clarified that Voluntary Registration doesn’t mean Licensing. He also explained about need to have Licensing audits for Class C & D Categories inspite of having ISO Certificates as this is linked to post market surveillance requirement. He also asked the mfrers to apply for license for products notified in Jan 2020 notification so that they can issue the licenses soon.

Rest of the session had series of speakers covering wide range of topics as follows :

Expert Presentation 2

Mr. Jayanta Roy Chowdhury
Scientist G & DDG - Standardisation-
Products & Methods, Bureau of Indian Standards.

"Quality & Safety of Medical Devices & Emerging Focus on Technical Standards"

Mr Chowdhury has touched upon the process of standardization of Medical Devices. He mentioned that BIS has created structure for medical equipments and hospital planning division council which comprises of 20 sectional committees (with 650 experts), 3 sub committees, 2 panels. BIS has so far published 1380 Indian Standards & 465 Standards harmonized with ISO/IEC. He spoke about the Standards National Action Plan which was rolled out by BIS based on the Indian National Strategy for tandardization initiative launched by Govt of India.

1st step towards the Standardization kick started with the HITES List of Commonly procured Medical Devices List from MoH&FW which had a list of 455 items. BIS has published 282 Standards for devices from this list and work in progress for about 81 devices, work yet to start for about 56 high risk devices.

Major ongoing standards devt exercise is happening currently for IVD devices, High Risk Devices, Class D Medical Devices, Surgical Instruments, Cold chain equipment, cyber security of connected medical devices, biomedical waste management, telemedicine and telehealth standards. Niti Aayog entrusted BIS with the task of developed standards for Priority Assistive Devices. BIS is taking active part in ISO/IEC International Standardization Work.

BIS is inviting any stakeholder to submit proposal for development of Standards and to comment on the draft standards published online. It also proposing creation of Standardization Cells in Industry Associations for better industry collaborations.

Expert Presentation 3

Mr. Anil Jauhri
Ex CEO – NABCB

Global Limelight on Authentic Certifications – an outcome of Pandemic Effect

Med Dev Industry is regulated across the globe and in India too Med Dev for healthcare is brought under Regulation. Covid 19 has exposed that global markets are also flooded with unauthentic QMS & Product Certificates similar to Indian experience. Market place needs an assurance that these certificates are genuine and reliable. Certification business is voluntary in Indian market and currently there is no regulation of these bodies and no single point of control to monitor their market practices. Anyone can set up a certification body and there is no legal bar too. Certifications are generally voluntary in nature and are driven by market demands, buyers demand etc and not because of regulatory push alone. ISO 13485 is the globally recognised Quality Management Systems Std for Med Dev. Indian MDR has mandated compliance to QMS but not mandated ISO 13485 in the Rules. However, during the curent transition phase (towards mandatory regulation), MDR has asked for compliance to ISO 13485 Std as prerequisite for Voluntary Registration process. However its only optional. But for the Certification programs of BIS – ISI Mark or QCI-AIMED driven ICMED Certifications, all other Certifications are done by Pvt Bodies in the market place. So a natural question that arises to our minds is the kind of certificates issued by these private bodies ! These fall under 2 categories – Authentic and Unauthentic Certificates. Mr Jauhri has demonstrated how these certificates look and how to identify both, by following simple steps. Accreditation of Certification Process is the internationally recognised way for improving the market confidence and hence IAF has a strong role to play. Authentic Certificates generally carry IAF logo but not mandatory though ! Mr Jauri raised a question to the Regulator and Industry to clarify too – MDR calls for compliance to QMS spec mentioned in Sch 5 and not mandated ISO 13485. So what will happen to ISO 13485 Certifications when industry gets into Regulation mode. This question needs an answer from the Regulator !