Apr 18, 2016
The Indian Ministry of Health and Family Welfare has issued draft rules that establish registration and quality system requirements for medical devices and IVDs distinct from pharmaceutical products.
Although the new rules pertain only to medical device manufacturers based in India, they are significant for all domestic and foreign participants in the country’s medical device market by showing that the Indian government now recognizes and distinguishes medical devices as a separate industry from pharmaceuticals. This move also suggests that the government may act on implementing other efforts and initiatives to develop a more formalized registration process in the country.
Previously, both pharmaceuticals and medical devices were grouped together under Schedule M of India’s Drugs and Cosmetics Rules; now, the government is proposing moving medical devices and IVDs to a separate structure, Schedule M-III.
As drafted, Schedule M-III contains its own set of requirements for quality management systems pertaining to all notified medical devices and IVDs, plus appendices covering Device Master Files and Site Master Files.
The Indian government has now opened a 45-day comment period for the draft rules, after which any comments received will be considered. Emergo consultants in India will continue monitoring these developments and report on any impacts foreign medical device registrants should expect.
India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015.
New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device registration and clinical trial regulations.
First, CDSCO has reiterated 14 categories of devices that do fall under India’s Drugs and Cosmetics Act and qualify for regulation:
The Indian Drugs Controller General’s office has launched a new task force to review processes and procedures currently in place at the Central Drugs Standards Control Organization (CDSCO) in order to boost efficiencies in how medical devices and drugs are reviewed and approved for sale in the country.