Obtaining a medical equipment license requires compliance with regulatory agencies such as the FDA (United States), CE Mark (Europe), CDSCO (India), and others. Devices are classed according to their risk (Class I, II, or III), with higher-risk devices requiring more stringent clearances. The procedure comprises documenting technical requirements, safety data, and clinical studies (if relevant). Manufacturers must follow standards such as ISO 13485 and GMP. Applications are submitted for approval, after which inspections and compliance checks are conducted. Once approved, frequent renewals and post-market surveillance assure the product’s continuous safety and efficacy. Regulations vary by nation, therefore enterprises must comply with the unique criteria of their target market in order to receive legal certification for marketing and distributing medical equipment.
ISI Mark for Medical Equipment Manufacturer
Applicable of Indian Standard For ISI Mark for Medical Equipment Manufacturer
| SNO | PRODUCT | IS NO |
|---|---|---|
| 1 | Clinical thermometers :Part1 Solid stem type | 3055 (Part 1) |
| 2 | Clinical thermometers :Part 2 Enclosed scale type | 3055 (Part 2) |
| 3 | Diagnostic Medical X-Ray Equipment | 7620 (Part 1) |
Frequently Asked Questions
No, BIS (Bureau of Indian Standards) is the regulatory body, while ISI (Indian Standards Institute) mark certifies product quality per BIS standards. ISI is a certification under BIS.
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