Medical device makers to soon face Facility audits; Test-Licence waiver on cards: DCGI
Speaking at CII’s MedTech Summit, the DCGI said, “Over the last two years, 30,000 product licences have been issued as we focused on facilitating approvals for the industry. Moving forward, we will see a significant increase in audits of the medical device industry, as companies have been given sufficient time to adapt to the new regulatory framework and there have been extensive discussions with…
New Delhi: India's regulatory body, Drugs Controller General of India (DCGI), plans to introduce facility audits for medical device manufacturers to ensure compliance with regulations. Speaking at CII’s 18th Global MedTech Summit, Dr Rajeev Raghuvanshi mentioned that 30,000 product licenses have been issued over the past two years.
The DCGI assured that the industry was aware of the regulator's expectations and was prepared for audits and inspections, which should not come as a surprise. The medical device industry in India is valued at around $16 billion and is poised to grow to $50 billion in the next five years. The DCGI also announced a reduction in the timeline for processing import applications to 145 days and a charter commitment of nine months.
Additionally, the agency is considering eliminating the test licence requirement for under trial devices, similar to provisions for drug manufacturers, during the R&D phase. The central agency is also creating a Joint DCGI-level position to provide greater operational independence to the medical device division within the CDSCO.
Written by urgent.news from ETHealthworld's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
Also reported by 1 other outlet
- Medical device makers flag new sterilisation labelling rule health.economictimes.indiatimes.com
