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Regulatory24 Apr 2026, 02:59 pm

Lords Mark gets license for high-risk HIV self-test device export

AI Summary

Lords Mark Industries Ltd has been granted a license by the Central Licensing Authority under the Medical Devices Rules, 2017, to manufacture a high-risk medical device for sale or distribution. The license is specifically for the "LordsMed HIV 1&2 Self Test" for export purposes, targeting markets in Africa, Latin America, and Europe. This approval makes Lords Mark among the second company in India and one of nine globally to receive such a license for this Class D In-vitro Diagnostic Device. The license, MFG/IVD/2023/000058 (Endorsement No. 8), was granted/endorsed on January 14, 2026. This strategic regulatory approval significantly strengthens the company's presence in the global healthcare and diagnostics segment by enabling the manufacture and export of a critical self-testing device.

Key Highlights

  • Lords Mark secured a license for a high-risk HIV self-test medical device.
  • The license enables manufacturing for export to Africa, LatAm, and Europe.
  • Company is among 2nd in India, 9th globally for this device category.
  • Strengthens company's position in healthcare and diagnostics segment.
  • This approval opens new international market opportunities.
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