(08 Oct 2018) Mini-Workshop Series on Regulatory Requirements for Medical Devices – 001 on 26 Oct 2018

Mini-Workshop Series on

Regulatory Requirements for Medical Devices

How to become an ISO 13485 Certified Medical Devices Company?

Topic: Introduction to ISO 13485 and QMS Implementation Strategy

When? – Friday, 26 Oct 2018 | Time 1345-1730 Hrs

Where? – Lecture Theatre, Venture Center, 100 NCL Innovation Park

Flyer |  Workshop Outline |

(30 July 2018) Report of R-Clinic at Pune held on 28 July 2018

Report on R Clinic  (R-Clinic-FY1819-02)

BIG Conclave 2018, Venture Center, Pune

RIFC’s second R Clinic organized on 27th July 2018 at the BIG Conclave 2018, Venture Center, Pune. It was an interactive session between participants who are BIG grantees and “experts in the regulatory field.”

R Clinic themed on the “Awareness on the current Regulatory requirements for Medical Devices in India” and “Overview of the regulatory requirements for Clinical Trials for Medical Devices in India.”

Ms. Syamni Sasidharan, Quality Assurance Executive from MolBio Diagnostics Pvt. Ltd., Goa. She spoke on the salient features of medical devices, including classification, working of licensing clearance system (Authorities, officers, and bodies) and product recalls on knowledge of risk to safety. Regulatory requirements for GMP manufacturing site, and post-approval regulatory mandates.

Dr. Prasad Kulkarni, Medical Director, Serum Institute of India Ltd., Pune. He highlighted the current Indian Drug Regulatory System, Apex/Committee, and their functions. He described the prior requirements for the clinical trials in India. Clinical trial phases, costs, and process flow as per the Schedule Y of D&C Act and its rules. He has pointed at the global position of India in the clinical trials market.

The overall feedback received was positive, though there are certain areas where the entrepreneurs would like more information like IVD devices, clinical performance requirements and willing to have a one to one talk with the regulators to clear specific queries apart from the acts and rules. Also, few participants are keen to undergo/ join a workshop on the particular processes of regulatory needs.

RIFC will be communicating with the entrepreneurs further to resolve their queries and work on the suggestions in the upcoming R Clinic.

Some of the pointers for our next R Clinic would be:

  1. One to one talks with regulators.
  2. Case studies group discussion on documentation requirements for clinical investigation, manufacturing for sale and risk management.

Navnath Kadam
RIFC, Venture Center, Pune

(12 July 2018) Report of R-Clinic at Chennai held on 10 July 2018

Report on R Clinic  (R-Clinic-FY1819-01)

Golden Jubilee Women’s Biotech Park (GJBP), Chennai

RIFC’s first R Clinic organized on 10th July 2018 at the Golden Jubilee Women’s Biotech Park (GJBP), Chennai, as a part of the “BIRAC TiE WinER program” under the initiative of BIRAC’s Regional BioInnovation Center (BRBC) at Venture Center. It was an interactive session between the “women entrepreneurs,” who are final participants of TiE WinER Award and “experts in the regulatory field.”

Wherein, it addressed the regulatory requirements and roadmap for securing the regulatory approvals, importance, and valuation of voluntary certifications in marketing a product in various jurisdictions. Also, the event enlightened the QMS, documentation requirements, identification, and mapping of applicable standards& guidelines.

Ms. Syamni Sasidharan, Quality Assurance Executive from MolBio Diagnostics Pvt. Ltd., Goa. She focused on the certification requirements, licensing process flow manufacture for sale or distribution, for In Vitro Diagnostic medical device and addressing the queries of licensing authorities under the new Medical Devices Rule 2017 of the D&C Act 1940 and the planning and preparation of Quality Management System as per ISO 13485:2016. She also clarified the route for clinical investigation of medical devices and clinical performance evaluation of In Vitro diagnostic medical device.

Mr. Anil Chaudhari, CEO of Operon Strategist, Pune. He explained the importance of Design Control at the early stage of product realization could avoid the post-market design changes, which ultimately lead to the business continuity and saves re-design cost. He showcased real-world examples of product recalls due to improper design, ignoring the user needs, not considering the historical incidents of relevant devices. A journey of Design Control as per 21 CFR 820.30 was an eye-opening for new entrepreneurs, where they understood the design input-output, a difference between verification and validation.

The overall feedback received was satisfactory, though there are certain areas where the entrepreneurs would like more information namely how to take their processes further and the companies/agencies that can help them with their entire regulatory process.

RIFC will be communicating with the entrepreneurs further to resolve their queries and or direct them to the appropriate consultants.

Some of the pointers for our next R Clinic would be:

Focus on areas of Biologics, Therapeutics, and drugs.
Cost vs. Compliance.

Navnath Kadam
RIFC, Venture Center, Pune