Indian Regulatory Unveil the Risk Class of Recently Notified Medical Devices

In an effort to develop a more dignified system of registration, India is implementing some new rules for medical devices that are sold and distributed in the country.  The new medical devices rule 2017 contains regulations regarding the use of risk-based classification of medical devices as well as the in-vitro devices along with the execution of unique device identification requirements. In addition to that, the manufacturers of the medical devices are subjected to manufacturing quality audits that are done by notified bodies specially authorized to do such audits by the government. Some of the rules also concern fee change depending on the new system.

The new regulation favours issuing license that is valid for three years rather than one year. The companies that possess devices that are already registered for selling in India will be given a transition period during which they can comply with the new rules. The new Medical Device Registration India rules by the Indian regulatory authorities also unveiled the risk class of medical devices. Before knowing about the details, you must know whether regulator classification matters or not.

·         The medical classification assists in the easy determination of what procedures you should follow before selling product.

·         It helps in establishing what is required, especially at the time of development of the product as well as design controls.

·         It is one of the vital components for the determination of the amount of money required for bringing the product to the market and lends you some idea about the involved duration.

Keeping this in view and for safety concerns, the Indian Central Drugs Standard Control Organization has set a risk classification of medical products that have been scheduled for notification and regulations starting from April 2020.

The notice directs to devices kinds, and all of them will be assigned as moderate to moderate-high class B and class C risk classifications.

·         CT scan equipment (Class C)

·         MRI equipment (Class C)

·         Defibrillators (Class C)

·         Dialysis machines (Class C)

·         PET equipment (Class C)

·         X-ray machines (Class C)

·         Bone marrow cell separators (Class B)

·         Nebulizers (Class C)

·         Blood pressure monitoring devices (Class B)

·         Digital thermometers (Class B)

·         Glucometers (Class C IVD)

·         Organ preservation solutions (Class C)

This classification as unveiled by Indian regulatory will help the Indian medical device market registrants, as well as their in-country representatives to obtain a good idea of problems related to cost, clinical data needs and import licensing authority while they sell their products in the Indian market.