The EU Medical Device Regulation (MDR) 2017/745 sets stricter requirements for medical device safety, performance, and transparency across the European Union. Full compliance became mandatory from May 26, 2021, with transitional provisions extending to 2028 depending on device class.
MDR License Importance
Legal Authorization: Required to manufacture, import, or sell medical devices legally in India.
Patient Safety: Ensures devices meet safety and quality standards before reaching users.
Market Access: Mandatory for listing products in hospitals, tenders, and government procurement.
Regulatory Compliance: Aligns with CDSCO oversight and avoids penalties or product recalls.
Global Recognition: Builds credibility for exports and international partnerships.
Business Growth: Enables expansion into regulated markets and boosts consumer trust.
Certifications Types
MD-5 license : Manufacturing license for medical devices
MD-6 license : Manufacturing Loan license for medical devices
MD-15 license : License to Import Medical Device
MD-17 license : Import License for testing of medical device
MD-40 license : License to Medical device testing laboratories
MDR Certification support as per client requirement
