New Medical Devices, Renewed Regulations: The Impact On The Healthcare Industry In India

Dr. Ashwini Kumar, Founder & CEO, CliniExperts Services Pvt. LtdThe New Medical Devices Rules are set to take centre stage from January 1, 2018, so as to enable rigorous classification of various diagnostic and therapeutic devices. The notification issued by the Ministry of Health and Family Welfare on the 31st January, 2017, highlighted some aspects that will be altered in the upcoming rules. The current revision will free medical devices from the label of “drugs” as per which they were being regulated under the aegis of the Drugs & Cosmetics Act of 1940.

Created keeping the best international practices in mind, the new medical rules have been structured as per the Global Harmonization Task Force (GHTF) framework.

Steps taken by the Government

The Indian Government has undertaken massive digitalization processes in the past two years with the aim of enhancing the processes of license application and registration, registration of medical devices, license renewal, clinical trial of devices for both import and manufacture of healthcare 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 application to payments and receipts of licenses.

Classification of Medical Devices:

As per the new rules, medical devices will be classified into the following four categories based on their risk potential:

1. Class A- low risk
2. Class B- low to moderate risk
3. Class C- moderate to high risk
4. Class D- high risk

Further to this classification, the rules demand that importers and manufacturers follow the requirements appropriate to the risk category of their product.

For Manufacturers in India:

Class A & B products will be supervised by the State Licensing Authorities (SLA),
while the Class C & D products will be under the aegis of the Central Licensing Authorities (CLA).(1)

The digitalization of the processes via the SUGAM portal has enabled simplicity and transparency, right from application to payments and receipts of licenses

Third Party Conformity and Certification:

Another master stroke by the regulators, the National Accreditation Board for Certification Bodies(NABCB)will certify Notified Bodies which will be responsible for ensuring 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 structure to this important segment.

Impact expected on the Healthcare Industry:

1. Right from the application to receipt of license, the entire 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 responsible manufacturing practices while keeping breathing 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. nImporters & 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 competitive production will ensure cheaper goods without compromising on the quality of life-saving medical devices.

8. The rules will ensure highest degree of quality, performance, and safety of devices manufactured in India. Thus, the local manufacturing sector will get a boost, generating 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-register 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 industry that follow Good Manufacturing Practices and work toward sustainable environments of the country, creating a fertile eco-system for everyone associated with the healthcare industry.