AUGUST 20179registration of medical devices, license renewal, clinical trial of devices for both import and manufacture of health-care devices. Geared to introduce a new healthcare industry to the world, the rules are expected to facilitate all processes. The digitalization of the processes via the SUGAM portal has enabled simplicity and transparency, right from ap-plication to payments and receipts of licenses. Classification of Medical DevicesAs per the new rules, medical devices will be classi-fied into the following four categories based on their risk potential: 1. Class A- low risk 2. Class B- low to moderate risk3. Class C- moderate to high risk 4. Class D- high risk Further to this classification, the rules demand that im-porters and manufacturers follow the requirements appro-priate to the risk category of their product. For Manufacturers in India Class A & B products will be supervised by the State Li-censing Authorities (SLA), while the Class C & D prod-ucts will be under the aegis of the Central Licensing Au-thorities (CLA). (1) Third Party Conformity and CertificationAnother master stroke by the regulators, the National Ac-creditation Board for Certification Bodies (NABCB) will certify Notified Bodies which will be responsible for en-suring that all Quality Management Systems are in place for the manufacturers of the Class A & B devices, and occasionally, for Class C & D devices as well. A common feature of regulations in the EU and USA, this 3rd party accreditation system is expected to bring in more struc-ture to this important segment. Impact Expected on the Healthcare Industry 1. Right from the application to receipt of license, the en-tire process will be online, adding to the simplicity and efficiency for buyers as well as manufacturers. 2. Self-compliance and self-certification methods for the low-risk device categories will bring in a fresh air of re-sponsible manufacturing practices while keeping breath-ing space for risk-based audits. 3. Separate rules for clinical trials for medical devices have been made at par with international standards and will be regulated by the CDSCO. 4. The new laws will set the Indian healthcare industry apace with global standards and regulatory practices.5. Importers & Foreign manufacturers will find it easier to gain entry into the Indian market and comply with the rules that have been simplified for self-application and self-regulation. 6. Fewer checkpoints to clear before a medical device gains entry into the market will make it easier for the introduction of devices by new and small/medium sized entrepreneurs. This will boost entrepreneurship and a rich competitive environment.7. Customers will benefit from these rules as the competi-tive production will ensure cheaper goods without com-promising on the quality of life-saving medical devices.8. The rules will ensure highest degree of quality, perfor-mance, and safety of devices manufactured in India. Thus, the local manufacturing sector will get a boost, generat-ing higher revenues for the country. This will also give a boost to high paying jobs for the country's youth that would otherwise set sail to foreign lands to learn and earn. 9. As per the New Rules, the process of Re-registration of medical devices at each 3 years has been abolished. Earlier the registered medical devices needs to be re-reg-ister by providing complete information, documentation and fees. A license or loan license issued in shall remain valid in perpetuity, subject to payment of license retention fee only.10. Lastly, these changes will create leaders in the indus-try that follow Good Manufacturing Practices and work toward sustainable environments of the country, creat-ing a fertile eco-system for everyone associated with the healthcare industry. The digitalization of the processes via the SUGAM portal has enabled simplicity and transparency, right from application to payments and receipts of licenses
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