The Central Drugs Standard Control Organization (CDSCO) on January 30, 2026, issued the Draft Guidance for Import of In-Vitro Diagnostic Medical Device for submission of Import licence applications to online portal.
The following has been stated namely: -
• The IVD shall be classified into the following: -
o Low risk- Class A
o Low moderate risk- Class B
o Moderate high risk- Class C
o High risk- Class D
• The Regulatory Certificates along with previous import licence has been stated.
• The Quality Management System certificate in respect of legal and actual manufacturing sites has been stated.
Comments/suggestions may be sent within 15 days at Google Form Link for providing comments.
[Notification No. CDSCO/IVD/GD/DRAFT/IMP/01/2026]
