India OKs Self-Certification for 1,000+ Medical Devices — A Doctor’s Take

As a clinician, I welcome any move that speeds access to safe, affordable equipment—but only if safety keeps pace. India will now allow self-certification for over a thousand low- to moderate-risk medical devices (think stethoscopes, wheelchairs, swabs, scissors). The aim is to cut red tape, boost Make-in-India, and ease shortages.

At the bedside, this could mean quicker procurement and lower costs for clinics and patients. Yet self-attestation shifts more responsibility to manufacturers—and to us. My checklist going forward:

• Prefer suppliers with proven QC and complaint-handling histories.

• Ask for batch records and post-market surveillance data, not just a declaration.

• Pilot new devices in controlled settings; get feedback from nurses and technicians.

• Report defects promptly so regulators can spot patterns early.

If implemented with transparent audits and real penalties for bad actors, this policy can widen access without compromising care. The goal is simple: faster, cheaper, and still safe tools for our patients.