The DIA India Medical Devices Conference 2020 is the first effort of DIA India to bring together leaders from the medical devices industry, regulatory and academia from India in New Delhi to discuss the current landscape and regulatory updates of the medical devices industry.

New upcoming medical devices regulations, changing landscapes and the evolution of latest technologies made for knowledge-packed two days sessions. Find out the key takeaways from this medical device conference.

1. The Impact of MDRs and The Way Forward for Medical Devices in India

• Indian government revamped the medical device regulatory process in 2017 with the publication of the Medical Device Rules (MDR) 2017. In Feb 2020, The Ministry of Health and Family Welfare has issued a notification to amend MDR 2017 as Medical Device (Amendment) Rules 2020 effective from Apr 01, 2020
• The new regulation will bring drastic changes from Apr 01, 2020. The first 18 months i.e. till Oct 01, 2021, the registration of the medical devices will be on a voluntary basis. After Oct 01, 2021, the registration of medical devices will become mandatory to all medical device's manufacturers and importers
• The medical devices will be registered through an online portal established by CDSCO to the Central Licensing Authority. The registration number on the label of the medical device will be mentioned on all devices by the manufacturer and importer
• The regulatory authority will validate the documents at any point in time as well as it will investigate any safety and quality-related failure or complaints. The regulators can cancel or suspend the registration of medical devices if it does not comply with the rules and regulation a per MDR 2020

 'The starting 18 months will be warranty registration to submit files and documents, get registration numbers for your medical devices. Another 12 months, for Class A and B medical devices, and another 24 months meaning total 42 months, is the notification to register the device completely'Lipi Chakhaiyar, Medtronic India

• The medical devices in India will be completely regulated and only regulated, standard products will only be marketed. The medical devices market will be organized and will create more opportunity for manufactures in India
• The MDR 2020 will enhance the accountability of manufacturers, importers, and distributors along with monitoring of entire lifecycle including use, malfunctioning and safety incidence
• The prices will be regulated and come under the control along with standardization of the devices   

'Now, with this entire difference, there is some stress which industries are going to face but unauthorized manufacturing of standard devices will go off completely'

'unorganized business is going to become an organized business, it's going to create jobs, it's going to create the opportunities of manufacturing in India. Till now, people were not taking the devices made in India because they were not regulated. It was not possible to get the free sale certificate or to receive the standardized outcome of the devices'Dr. Ashish Indani, TCS India

2. Application of the latest technologies in device design and development

• Cutting edge technologies are being continuously implemented in medical device development. The technologies which are impacting the masses are wearables and connected devices which are now being developed for self-monitoring different aspects like hypertension, diabetes, and arrhythmias
• Other technologies that have been evolved over time and are implemented in medical device development are personalized medicine based on genetic data, Telehealth, Artificial intelligence (AI) and Machine Learning (ML), Robotics, NFC, Medical 3D printing, IoT, Medical cloud, Quantum computing, etc.

'The era is evolving with wearables, digital health practices including apple and Xiaomi watches which helps us in examining the different parameters like hypertension, diabetes and irregular heartbeats. Additionally, in Oncology there is also the US FDA approved app Oleena, which address decision-making, side effects like nausea, vomiting and helps in giving personalized care'Dr. Saurabh Kumar, IQVIA, India

3. Clinical Evaluation and Investigation for Devices

• The clinical evaluation and investigation of Medical devices depends on the device type along with the regulatory pathway
• The process of investigation will start with the approval of the clinical trials from CDSCO within 90 days, then moving to next milestone approval from the Ethics Committee on Clinical Trial Protocol
• The approval will lead to manufacturing and import of the unapproved medical device in 30 days, further, the company or the investigator should report the AEs as per the protocol
• The outcomes of the study will guide the design, also the investigational site will also play a great role in the successful completion of the study

'The four main aspects will be widely affected by the trials: Sponsor, Investigator, Patient, Regulatory Authority. The first stakeholder- Sponsor would have a design, development release. The design would be difficult because we are not talking about drug, it's a novel device with new requirements including endpoints. Similarly, with Investigator, the experience will be different from the traditional ones and will also need specific training to undergo such trials. Patient- normally, are explained about the trial, but when the device is with AI it is difficult to explain the scenario as there will be no AEs in the trial available. Lack of enough guidance or documents is another challenge. The design will be difficult' Sundeep Agarwal, Datt Mediproducts Pvt Ltd.

4. Determining Preclinical Development Needs: Mechanical, Animal and Biocompatibility Studies

• To increase the success rates of the trials, a preclinical trial is compulsory
• The new medical devices containing new material requires biocompatibility with animals following the US FDA's regulation Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
• Specifically, to check biocompatibility specific test requirement should be done on the basis of ISO 10993

5. Use of Medical Device in An Off-Label Indication - Boon in Disguise?

• Re-using medical devices is dangerous and no one should promote the reuse of single-use devices. Alternatively, the industry should evolve with new products where either the cost is low for the single-use device, or it should be designed as a reusable product which can also reduce the medical waste

'I would like to mention that sometimes off-label is not the choice, rather it is important. And, for single-use products, there should be some process or standards as the US is following. Also, if the physicians are using the product for saving patients life, they should be allowed. On the other hand, there should be a platform where we can report such kind of cases. And somehow you never know the manufacturer extend the indication of product moving not the main indication then it will be very important from the regulator, manufacturer and reporting perspective where we can state that the use of the off label is safe.' Sahjogita Kathuria, Terumo, India.

• Mainly the four aspects should be focused ongoing for a clinical trial
• Sponsor, who is wholly responsible for designing the trial and it will a challenge if we talk about the device
• Investigator- The experience for the trial will be new including endpoints, requirements, etc.
• Patient- undergoing with the trial should be aware of outcomes and this will also serve as a challenge because the AEs are not available
• Regulatory Authority - with lack of documents and guidance things will not be easy

6. Future perspectives of New age medical technology in Medical device space

• These need to go through rigorous clinical trials for devices which are different from drugs and have several challenges
• There are multiple issues in the area of the recruitment of subjects with sham controls, ethical aspects, Insurance, and regulatory issues
• Devices/robotics working in medical space may have security threats along with possibilities of hacking and adverse programming leading to disasters requires planned auto checks

For further inquiries of next year event, please reach out to:
Niveda Ramkumar Niveda.Ramkumar@diaglobal.org