eMedica: the regulatory and evidence position, stated exactly

I have published the complete position on eMedica — what it is licensed as, what it is not, what the documented record contains, and what the evidence does and does not show. Eighteen questions, answered exactly, on a page I control and keep current.

Some of those answers are no, and they are in the same type as the rest. That is deliberate. Anyone checking will find an answer somewhere, so it should be mine, correct, rather than someone else’s.

What the documented record actually contains

  • CDSCO Class A manufacturing licence MFG/MD/2023/000926 (Form MD-5), issued by the Food & Drug Administration, Maharashtra, under the Medical Devices Rules, 2017.
  • ISO 13485:2016 quality management system.
  • IEC 60601-1 electrical safety, tested at a NABL-accredited laboratory: measured patient leakage current 1.3 microamperes against a 10 microampere limit.
  • Patent family led by US 12,226,183 B2 (granted 18 February 2025), further granted in Japan, South Korea, Australia, Canada, Saudi Arabia and South Africa. Assignee on the record: Individual.

And what it does not

A manufacturing licence is permission to manufacture under a quality framework. It is not a finding that a device is effective, and it has no effect outside India. ISO 13485 certifies a quality system, not a clinical benefit. A granted patent means an examiner found the claims novel and inventive against the prior art searched — it does not mean anyone tested the device on a patient.

eMedica is adjuvant: used alongside conventional medical care under a qualified practitioner, never in place of it. No randomised, sham-controlled trial has been published, and no claim of cure or of clinical efficacy is made for any condition.

Why publish it this way

A page that only answers the comfortable questions is not a reference. A licence number, a standard, a measured figure and a grant number are things a reader can verify without my help — and that is worth more than any adjective.

Originally published at https://hemant-rohera.vercel.app/emedica-faq.html — that page is the canonical version and is kept current. Clinical questions and the current state of the evidence are handled by the manufacturer at emedica.in.

Nothing here is medical advice. Decisions about care belong with a qualified healthcare professional.

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