First edition Indian regulatory and Quality Summit 2018 concluded successfully
First Indian regulatory and Quality Summit 2018 was organised by Association of regulatory Affairs professional (ARAP) and National Accreditation Board for Certification Bodies (NABCB) – Quality Council of India (QCI) on 15th Oct’2018 at The Lalit Hotel , New Delhi,
Dr. Puranik (President Of ARAP) welcome all delegates and gave brief presentation on past activities done by ARAP.
DR. BR Sikri gave keynote of summit and focus on the manufacturing of quality product by following recent regulation issued by CDSCO to manufacture the quality medical device in the country. He also suggest to incorporate the new forum for medical device community, so that better communion will done between the government and stakeholders.
Mr. A K Nasa- Head of Office/Licensing Authority – Drug Control Department- Delhi gave awareness about the responsibility of State FDA for granting of manufacturing licenses for Class-A and Class – B devices. He also informs the industry about the role and responsibility of notifying bodies to audit the manufacturing sites.
Dr. K Bangarurajan elaborates the classification of medical devices (which was based on the risk associated with proposed medical device) role and responsibility of notifying bodies and inspection of manufacturing of sites. he also said that Drug inspector is inspect the manufacturing sites prior to approval of manufacturing class-II and Class-IV devices. He said till date 4 notifying bodies are approved by CDSCO.
Mr.. Shyam Bang Chairman of NABCB said that there is strong need of strong regulation of assess the manufacturing site for development of quality products. They focused on opt ISO guidelines for development of Quality products.
DR. VG Somani – JDC- CDSCO said that we are 20 years late in regulation of medical device in country but are on right track and will soon achieve the targets to becomes a hub of medical device in world.
He also said that online portal is working smoothly and a good response was receded from manufacturer and importer of medical devices. He explained the need of various term related to the medical device rule 2017.
He said that apart from the quality performance of medical device it is essential to shoe the clinical performance of medical device.
clinical performance is not required if CSCO approved predicate device or manufactured shows substantial equivalence of device, his main focus is on the implantation of Quality management system (QMS) in manufacturing units to produce quality products.
During the Panel discussion Dr. Ravikant (said that their main focus on the notifying bodies and they will routinely review their activity and proper action will be taken against notifying bodies if their activity found suspicious. He stressed on the duty of the port officer so that the storage condition will be maintained at port so that quality of product maintained.
Apart from Govt. officials there were representation from Industry body like AIMED, Mr.Rajiv Nath Forum Coordinators stressed upon ICMED certification.He gave full presentation on regulation and standards ,requirements etc.
Mohammed Ameel a senior consultant in NHRC has gave full insight on “Regulatory Landscape in India ” and moderated the panel of FSSAI,regulators ,industry and discussed various new Medical Device rules 2017.