Indian regulations called the Materiovigilance Program of India (MvPI) to institutionalize post-marketing vigilance of medical devices to monitor patient safety throughout the country have been in place for a number of years. Under this program, a manufacturer, importer, distributor, healthcare professional, patient, or other entity can report an adverse event arising out of a medical device that ‘went wrong.’
The reporting can be done through an editable medical device adverse event reporting form, a toll-free helpline number, or a field safety corrective action form. The MvPI envisaged not only notifying the regulatory authority and healthcare professionals on suitable corrective actions, but also mandating instant recall of the particular device responsible for the adverse event, by the manufacturer and the distributors.
The MvPI also entails examining benefit to risk ratio of a medical device, creating evidence-based data. This data supports regulatory bodies such as India’s Drug Controller, the Central Drugs Standard Control Organization (CDSCO), on device regulation, facilitating exchange of safety-based information among different stakeholders, and cooperating with other health-care organizations and international agencies for information exchange and data management.
A number of Medical Device Monitoring Centers were identified across the country for reporting Medical Device Adverse Events. A suspicious event could be categorized in five different ways – not related, unlikely, possible, probable, and causal relationship – covering virtually all scenarios. Currently, five working days is the timeline for reporting an Medical Device Adverse Event after becoming aware of it, and 30 calendar days for reporting the event after ascertaining its fundamental cause.
The Medical Device Rules 2017 further streamlined investigation and reporting, and set the stage for an independent regulatory framework for medical devices separately from drugs and medicines. One of the rules said, “the license holder shall inform the State Licensing Authority or Federal Licensing Authority (as the case may be) of the occurrence of any suspected unexpected serious adverse events and take necessary action, including any recall within 15 days of such event coming to the notice of license holder.
The 2017 Rules also created the four-fold classification delineating devices and equipment based on risk assessment: the low risk Class A and low-moderate risk Class B devices are to be regulated by the state licensing authority, and the moderate-high risk Class C and high risk Class D devices are to be regulated by the federal licensing authority or the CDSCO.
As an outcome of the four-fold classification, the government specified the risk category of different devices for different types by end-use. Some of these broader categories of care are: Rehabilitation, Dental, Obstetrical and Gynecological, General Hospital, Neurological, Software, Oncology, Gastroenterology, Personal Protective Equipment, Nephrology and Renal Care, Operation Theater, Pain Management, Physical Support, Dermatological & Plastic Surgery, Cardiovascular, ENT, Respiratory, Radiotherapy, Ophthalmology, Urology, Pediatrics & Neonatology, and Anesthesiology.
In April 2018, the government also issued guidelines on essential principles of safety and performance necessary for manufacturers to follow and implement for both IVD (in vitro diagnostic) and non-IVD devices.
While laying down product standards, the guidelines caution manufacturers in terms of chemical, physical and biological properties of materials used and protection against a range of risks including infection and microbial contamination, radiation, mechanical risks, and risks from supplied energy sources, among others. The guidelines also entail removal of risks by incorporating materials of biological origin, ergonomic features, human factors, or the environment in which a device will be used.
