Certko currently tracks 62 notified Medical Devices & Textiles products, each mapped to its IS standard. Open any product to see its QCO status — mandatory, upcoming or voluntary — along with HSN code and applicable order.

How much does BIS testing cost for Medical Devices & Textiles products?

Reported laboratory test charges in this category range from ₹2K – ₹14.5L (excluding GST), depending on the standard, the lab and the number of models tested. Annual BIS marking fees apply on top and are listed on each product page.

How long does BIS certification take for Medical Devices & Textiles?

Most Medical Devices & Textiles applications complete in 10-18 weeks, covering documentation, sample testing at a BIS-recognised lab and, for ISI licences, the factory inspection.

Can Certko manage the whole process for my Medical Devices & Textiles product?

Yes — our consultants handle standard mapping, application drafting, lab coordination and inspection readiness end-to-end. Request a free quote and we respond within 24 hours.

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★★★★★

“Certko showed me the exact IS standard, real lab prices and a shortlist of labs near my warehouse in one evening. The certification quote I got through them was 30% below what I had been offered elsewhere.”

RRohan T.Appliance Importer, Mumbai

★★★★★

“SABER and GMARK hand-offs used to stall our shipments. Certko’s team kept both tracks moving and we cleared customs without last-minute surprises.”

OOmar F.SABER Compliance Lead, Riyadh

Need a quote for Medical Devices & Textiles?

Certko helps with scheme mapping, lab coordination and filings for India and export markets. Ask for a free quote — we reply within 24 hours.

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Medical Devices & Textiles

Disposable Sanitary Napkin/Panty Liner/Maternity Pad/Period Panty

Disposable Adult Incontinence Diaper

Disposable Baby Diaper Specification

Food For Special Medical Purpose Intended For Infants – Specification

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs

Medical Electrical Equipment Part 2 Particular requirements for basic safety and essential performance Section 12 Critical care ventilators

Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 2 High frequency surgical equipment and high frequency surgical accessories First revision

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators

Medical textiles - Surgical face masks

Medical textiles – Surgical gowns and surgical drapes – Specification

Sanitary napkins – Specification

Single-use Sterile Rubber Surgical Gloves – Specification

Surgical rubber gloves

Blades, surgical, detachable (Bard Parker Type) and handles

Disposable surgical rubber gloves specification

MEDICAL TEXTILES – COTTON ABSORBENT GAUZE – SPECIFICATION ( Fifth Revision of IS 758 )

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 20 Infant Transport Incubators First Revision

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 34 Invasive blood pressure monitoring equipment

Medical Electrical Equipment: Part 2 Particular Requirements for the Basic Safety and Essential Performance: Sec 13 Anaesthetic Workstation

Medical Textiles - Cotton bandage cloth

Medical Textiles Bio-Protective Coveralls Specification

Medical Textiles Underpad Specification

Medical electrical equipment Part 2 Particular requirements for the Basic Safety and essential performance Section 50 Infant Phototherapy Equipment

Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 49 Multifunction patient monitors

Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests

Medical electrical equipment: Part 2 - 30 particular requirements for basic safety and essential performance of automated non - Invasive sphygmomanometers

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 16 haemodialysis, haemodiafiltration and haemofiltration equipment

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 18 endoscopic equipment

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers

Single - Use medical examination gloves: Part 1 specification for gloves made from rubber latex or rubber solution

Specification for steel wire for needles

Textiles - Medical/Surgical Gowns and Medical/Surgical Drapes

Bed, Fowler's, Hospital

Geosynthetics – — Needle punched nonwoven geobags for coastal and waterways protection – Specification

Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis

Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 69 Oxygen Concentrator Equipment

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators First Revision

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 31 External Cardiac Pacemakers with Internal Power Source First Revision

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 40 Electromyographs and evoked response equipment

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds

Medical Textiles Bedsheet and Pillow Cover Specification

Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 84 Ventilators for emergency medical services environment

Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs

Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 54 X-ray equipment for radiography and radioscopy First revision

Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 56 clinical thermometers for body temperature measurement

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 19 baby incubator

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 21 infant radiant warmer

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 37 ultrasonic medical diagnostic and monitoring equipment

Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 39 peritoneal dialysis equipment

Medical textiles – Coveralls for COVID 19 – Specification

Medical textiles – Dental bib/Napkins – Specification

Orthophosphoric Acid — Specification ( Third Revision )

Reusable Sanitary Pad/Sanitary Napkin/Period Panties

Reusable Sanitary PadSanitary Napkin Period panties Specification

Single-use medical examination gloves Part 1 Specification for gloves made from rubber latex or rubber solution Second Revision

Specification for disposable artificial insemination gloves

Specification for steam sterilizers: Part 1 horizontal cylindrical and horizontal rectangular steam sterilizers, pressure type (For Hospital And Pharmaceutical Use)

Specification for sterilizer, shallow (Dressing Drum)