🏅 Our Certifications & Regulatory Compliance

At Medichem Electronics, we are committed to delivering safe, reliable, and high-performance medical devices that meet the most stringent global standards. Our certifications are a testament to our dedication to quality, compliance, and patient safety.

✅ Regulatory Certifications

• ISO 13485:2016 – Quality Management System for Medical Devices
  We are ISO 13485 certified, which ensures that our design, development, manufacturing, and servicing processes meet internationally recognized standards for medical devices.

• CDSCO Manufacturing License (MD-5 & MD-7)
  Licensed by the Central Drugs Standard Control Organisation (CDSCO), Government of India for the manufacture of Class B and Class C medical devices including:

  • Electrosurgical Units (Class C)

  • Infant Warmers (Class C)

  • Phototherapy Units (Class B)

  • OT Lights (Class B)

  • Physiotherapy Devices (TENS, IFT, MS, US)

• CE Certification (OT Light)
  Our products comply with the European Union’s Medical Device Regulation (MDR 2017/745) and bear the CE mark where applicable.

• IS 13450 Certified
• ZED Certified

🧪 Product Testing & Compliance

All our devices undergo rigorous IEC 60601 safety testing and performance evaluation through NABL-accredited labs. Our certifications ensure:

• Electromagnetic compatibility

• Electrical safety

• HF leakage current compliance

• Tissue feedback and sealing efficiency (for ESUs)

• Thermal test on tissue

✅ We are registered as an OEM on the Government e-Marketplace (GEM) and proudly listed under the Make in India (MII) initiative.
We also hold a valid MSME (Udyam) certificate, making us eligible for purchase preference and participation in government tenders and healthcare procurement programs.

For request of certificate copy, operative manual, service manual, product catalogue & other product details mail us on info.medichemelectronic@gmail.com, we will contact you within 2 business days.