The Government of India recently notified new rules to regulate medical devices in India. These rules, which come into effect on January 1, 2018, have been framed with the objectives of encouraging both foreign investment into India’s growing medical devices sector (where 100% foreign investment is allowed, without prior government approval), and the manufacture of medical devices in India.
Scope
Under the new rules, medical devices cover both substances (e.g., diagnostic substances or disinfectants) and devices. As a result, the rules classify all medical devices into two broad categories: (i) in vitro medical devices, and (ii) other medical devices. Within each category there are four classes of devices based on relative risk (i.e., class A: low risk, class B: low-moderate risk, class C: moderate-high risk, and class D: high risk). The rules then contain specific parameters for classification of devices within each of these four classes.
The rules also require medical devices in India to meet standards prescribed by the Bureau of Indian Standards (BIS). If no BIS standards have been prescribed, products meeting ISO, IEC or other applicable pharmacopeia standards are eligible to be treated as conforming to the rules.
Licensing
Effective January 1, 2018, a central (i.e., national) licensing authority will regulate the import of all medical devices into India, the manufacture of class C & D devices, clinical investigation and approval of investigational medical devices, and clinical performance evaluation and approval of new in vitro diagnostic medical devices. State-level licensing authorities will regulate the manufacture for sale or distribution of Class A and Class B medical devices, and the sale, stock, exhibition, offer for sale or distribution of all classes of medical devices.
This said, the licensing process has been significantly eased. For instance, the rules contemplate self-compliance by manufacturers of low risk medical devices (the rules allow manufacturing licenses for Class A medical devices to be granted without prior audit of the concerned manufacturing site). In addition, the rules allow the licenses to be applied for and processed electronically, and the burden of seeking license renewals has also been eased—manufacturing and import licenses remain valid till suspended, cancelled or surrendered.
Audit and Exemptions
Designated agencies, accredited by the central government, will be authorized to carry out audits of the manufacture of medical devices to verify conformity with quality management systems and other applicable standards. The rules also contain extensive provisions covering labelling of medical devices, clinical investigations and clinical performance evaluation and testing of medical devices.
Specific provisions in the new regulations do not apply to a limited, identified group of medical devices, including custom made devices, and certain medicated bandages and dressings. In this regard, mass produced devices, which only need adoption to meet the specific requirement of a medical practitioner or other professional user, will not be considered custom made devices.
Conclusion
The rules are a welcome measure that provide much needed transparency and certainty for a growing industry that was not very well regulated in the past. One hopes the implementation of the rules will reflect these principles of transparency and certainty going forward.
