Mediqol

The Indian Central Drugs Standard Control Organization (ICDSO) has recently published formal proposals outlining how it intends to regulate the medical devices sector. Currently medical devices are either regulated as drugs (if they fall in a list of ten product types) or not regulated.

The plans include the introduction of a risk based classification system with increased regulatory requirements and documentation being required for higher risk devices. The plans also suggest the involvement of Notified Bodies in the certification process and the introduction of a Indian equivalent of the CE mark.

If you’d like a copy of the 83 page document please drop us an email at enquiries@mediqol.com