ARTICLE SUMMARY:
In this week’s Pathways Picks: India amends its regulations to further rely on EU CE marks, and makes other simplifications; Brazil issues in-depth submission guides; Germany addresses health app modifications; FDA picks first two firms for the READI-Home Innovation Challenge; Taiwan advances eSubmissions; and more medtech policy updates.
Global Picks
India harmonizes, simplifies
The country amended its device regulations this month to simplify certain requirements, including streamlined access for EU-certified devices to India’s market. While devices without a predicate on India’s market would typically be subject to a clinical investigation, an August 14 amendment to the country’s Medical Devices Rules would allow devices with an EU CE mark to forgo such a study. Separate, same-day amendments issued by the Central Drugs Standard Control Organization (CDSCO) would lighten documentation requirements for companies that outsource sterilization activities and would establish a uniform fee structure for device testing laboratories to reduce variation and uncertainty. “The Medical Device Rules were amended for better clarity and ease of doing business,” affirmed Chandrashekar Ranga, CDSCO’s Joint Drugs Controller, in an August 24 LinkedIn post.
