Why Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators needs BIS certification
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators falls under the Medical Devices & Textiles category and is covered by IS 13450: PART 2: SEC 4 (2018). Manufacturers and importers must obtain the ISI mark licence from the Bureau of Indian Standards before the product can be manufactured, imported, stored or sold in India. Selling a notified product without a valid BIS licence can lead to seizure of stock, marketplace delisting and penalties under the BIS Act, 2016.
Testing & costs
Sample testing for IS 13450: PART 2: SEC 4 (2018) is currently available at 3 BIS-recognised laboratories across India. Reported test charges range from ₹8L – ₹10.9L (excluding GST), depending on the laboratory, the number of models/varieties and the tests included in the scope. Certko can help you pick a lab that balances cost, turnaround time and location.
Typical process
- Standard & scope check – confirm your exact product variant maps to IS 13450: PART 2: SEC 4 (2018).
- Documentation – factory details, quality control records, test equipment list and trademark proof.
- Sample testing – testing at a BIS-recognised lab against every clause of the standard.
- Factory inspection – BIS officers audit the manufacturing site (for ISI mark licences).
- Grant of licence – on successful evaluation, the licence/registration is issued, typically within 10-18 weeks.
