As per the BIS Act 2016, obtaining a BIS Certificate for Ear, Nose, and Throat Surgical Instruments in India is mandatory. Ear, Nose, and Throat surgical instruments must meet the standards of quality, precision, and reliability, as they play a critical role in ensuring the success and safety of delicate medical procedures.

For manufacturers, obtaining BIS certification is more than just a regulatory requirement. It validates the credibility of their products and ensures compliance with Indian standards. It also helps prevent non-certified instruments from being sold or marketed, offering assurance to healthcare providers and patients.

Therefore, in this article, you’ll learn how to get BIS Certification For Ear, Nose, And Throat Surgical Instruments, the benefits, the fee involved, and many more. So, whether you’re a manufacturer or importer, reach out to us, and our expert team will guide you, ensuring full compliance and approval.

What Is BIS Certificate For Ear, Nose, And Throat Surgical Instruments?

A BIS Certificate for Ear, Nose, and Throat Surgical Instruments is a mandatory certification in India issued by the BIS that confirms these instruments comply with national safety, quality, and performance standards.

The Bureau of Indian Standards operates under the Ministry of Consumer Affairs in India. BIS engages in various activities, such as product certification, quality control testing, hallmarking, and calibration schemes.

BIS’s primary objective is to protect public health by ensuring that products meet safety and quality standards. It also protects consumers from hazards by enforcing strict guidelines and promoting consumer confidence and trust.

What Is Ear, Nose, And Throat Surgical Instruments?

Ear, Nose, and Throat Surgical Instruments are specialized tools healthcare professionals use for diagnosis, treatment, and surgical purposes. These instruments are carefully designed for surgical procedures, ensuring precision, safety, and effectiveness.

Surgical instruments are used for making incisions, suturing, and other surgical procedures.

Scalpels, blades, forceps, suction tubes, speculum, Laryngoscope, and bronchoscopes are typical ear, nose, and throat surgical instruments.

Who Can Apply For BIS Certificate For Ear, Nose, And Throat Surgical Instruments?

The following person or entity can apply for a BIS Certificate for Ear, Nose, and Throat Surgical Instruments:

• Manufacturers of Ear, Nose, and Throat Surgical Instruments
• Importers who want to market and sell surgical instruments
• Any authorized person on behalf of a foreign manufacturer can apply

Benefits Of Obtaining BIS Certificate For Ear, Nose, And Throat Surgical Instruments?

BIS certificates have some essential benefits, which are mentioned below:

• Provide quality assurance of products through rigorous testing.
• Ensure legal compliance, which is mandatory for selling products in India, by adhering to regulatory standards.
• Enhances global recognition and unlocks new market opportunities.
• Build consumer trust with the ISI Mark, ensuring legal market assessment of the product.
• Boosts consumer confidence as a BIS certificate is an assurance of quality and reliability.
• It ensures compliance with regulatory standards.
• Avoid legal consequences like chances of product recall from the market or rejection.

Impact Of BIS Regulations On Ear, Nose, And Throat Surgical Instruments

BIS plays a significant role in ensuring the safety and quality of medical tools and instruments used for surgical purposes. It develops and enforces quality and safety standards for medical devices, including ear, nose, and throat surgical instruments, ensuring they meet essential regulatory requirements.

BIS aligns its regulations with internationally recognized standards such as ISO (International Standard Organization) and IEC (International Electromechanical Commission), which specify the safety and biocompatibility of medical devices.

BIS certification helps prevent substandard and unsafe products in the healthcare system, safeguarding consumer safety and enhancing trust in medical devices used nationwide.

Read More: BIS For Medical Devices

How To Obtain BIS Certificate For Ear, Nose, and Throat Surgical Instruments?

The procedure of obtaining a BIS Certificate for Ear, nose, and Throat Surgical is quite complex and lengthy. But ELT corporate will help you make this process seamless and quick. The various steps are as follows:

1. Identify the BIS Standard for the product
2. Prepare all the required documents
3. Apply online through the BIS Portal
4. Submit all the documents
5. Make the payment of the fees
6. Inspection of the Manufacturing site by BIS Officials
7. Review of application forms and documents.
8. Create Performance Report
9. After successful review and verification, the license is granted
10. Audit by BIS conducted at regular intervals to ensure compliance

Documents Required To Get BIS Certificate For Ear, Nose, and Throat Surgical Instruments

For the hassle-free and smooth process of getting a BIS Certificate for Ear, Nose, and Throat Surgical Instruments various documents must be submitted listed below:

• Application form
• Personal details of the applicant
• Product Details
• Proof of Manufacturing/business establishment
• Manufacturing License
• Product test reports from a certified laboratory
• Site Layout
• QMS Documentation
• Declaration of conformity (if applicable)
• MSME/SSI Certificate
• List of equipment or Instruments
• Fee payment receipt
• Power of Attorney certificate if any
• Other documents as per need or requirements

Validity Of BIS Certificate For Ear, Nose, and Throat Surgical Instruments

The validity of BIS Certification is one year from the certificate’s issuance date. After this period, the certificate can be renewed in the given time, along with the fees. Suppose the BIS Certificate is not renewed at the given time, or you renew it after expiration. In that case, a late fee of Rs.5000 will be submitted along with the application form and necessary documents.

Timeline For Obtaining BIS Certificate For Ear, Nose, and Throat Surgical Instruments

The BIS certificate process for India’s Ear, Nose, and Throat surgical instruments usually takes 30 to 40 days, depending on product complexity and application completeness.

List Of Indian Standards Of BIS For Ear, Nose, And Throat Surgical Instruments

Here is a list of the Indian standards required for BIS Certification for Ear, Nose, and Throat Surgical Instruments. You can review them here:

SI. No.	IS No.	TITLE
1	IS 10272: 1982	Specification for draffin suspension apparatus
2	IS 10308: 1982	Tracheostomy Tubes and Guides, Cubley’s Pattern
3	IS 10344: 1982	Specification for gag frame, Davis-Boyle, and tongue plates
4	IS 10725: 1983	Specification for knife, myringotomy
5	IS 10726: 1983	Specification for knife, meatal skin incision
6	IS 10786: 1984	Mirror, Rhinoscopic, ST. Clair Thomson’s Pattern
7	IS 10846: 1984	Speculum, Nasal, Killian’s Pattern
8	IS 11318: 1985	Bronchoscope, Aspirating, Negus’ Pattern
9	IS 11319: 1985	Oesophagoscope, Negus’ Pattern
10	IS 12901: 1990	ENT surgery instruments – Laryngeal fine grasping forceps, crocodile jaws, straight – Specification
11	IS 12911: 1990	ENT surgery instruments – Laryngeal forceps, oval cup – Specification
12	IS 13169: 1991	Ent surgery instruments head mirror – Specification
13	IS 13179: 1991	Ent Surgery Instruments – Tracheostomy Tubes, Chevalier Jackson’s Pattern
14	IS 17407: 2020	Digital Otoscope — Handheld Type
15	IS 3758: 2018	Hooks, aural – Specification (First Revision)
16	IS 3760: 2021	Probe, Aural, Jobson Horne’s Pattern — Specification (First Revision of IS 3760)
17	IS 3788: 1966	Specification for specula, aural
18	IS 3799: 2019	Forceps, aural and nasal, crocodile action – Specification (First Revision)
19	IS 3807: 2000	Ent surgery instruments – Forceps, dressing, aural and nasal- Specification (First Revision)
	(1 Revision)
20	IS 4487: 2000	ENT Surgery Instruments – Forceps, Tonsil Artery (Birkett’s Pattern)
21	IS 4488: 2018	Forceps, Tonsil Holding (Muck’s and White’s Patterns) Specification ( First Revision )
22	IS 4489: 2018	Forceps, Nasal Turbinate, Luc’s — Specification ( First Revision )
23	IS 4504: 2018	Forceps, peritonsillar – Specification (First Revision)
24	IS 4514: 2018	Forceps, Tonsil Dissecting (Waugh’s Pattern) – Specification ( First Revision )
25	IS 4520: 2018	Forceps, Punch, Nasal Citelli’s Antrum and Hajek’s Sphenoidal— Specification (First Revision)
26	IS 4959: 2018	Raspatory, Nasal, Howarth’s – Specification (First Revision)
27	IS 4994: 1968	Specification for Forceps, Redressing, Walsham’s Right, Left, and Straightening
28	IS 5140: 1969	Specification for auriscope
29	IS 5147: 1969	Examination Lamp with Bull’s Eye Condenser (Floor Model)
30	IS 5338: 1969	Specification for catheter, eustachian
31	IS 5377: 1969	Speculum, Nasal, Thudichum’s
32	IS 5412: 1969	Saws, Nasal, Joseph’s Pattern
33	IS 5720: 1970	Retractor, Mastold, Self-Retaining (Mollison’s pattern)
34	IS 5723: 1970	Specification for a mallet with a fluted handle for ENT surgery
35	IS 5732: 1970	Gouge, Mastoid (Jenkins’ Pattern)
36	IS 5747: 1970	Retractor, Endaural (Lempert’s Pattern)
37	IS 6463: 1972	Burs, Antrum (Tilley’s Pattern)
38	IS 6464: 2000	ENT Diagnostic Instruments – Tuning Forks (Gardiner Brown’s Pattern)
39	IS 6465: 1972	Trocar, Antral, with Cannula (Tilley Lichtwitz’ Pattern)
40	IS 6514: 1972	Nasal Cartilage Knife (Ballenger’s Pattern)
41	IS 7007: 1973	Specification for E.E.N.T. (Eye, Ear, Nose And Throat) diagnostic set
42	IS 7282: 1975	Chisel, Labyrinth, Straight, Lake’s Pattern
43	IS 7710: 1975	Snare, Tonsil, Eve’s Pattern
44	IS 7711: 1975	Curette, Adenoid, Beckmann’s Pattern
45	IS 7712: 1975	Curette, Adenoid, St. Clair Thomson’s Pattern
46	IS 7713: 1975	Retractor, Light Model, Weislander’s Pattern
47	IS 7756: 1975	Depressor, Tongue, Lack’s Pattern
48	IS 8093: 1976	Curette, Ballance’s pattern
49	IS 8094: 1976	Hook, Cerumen, Cawthorne’s Pattern
50	IS 8128: 1976	Elevator, Farabeuf’s Pattern
51	IS 8129: 1976	Forceps, Tonsil Artery, Curved, Scott’s Pattern
52	IS 8136: 1976	Seeker, Dundas Grant’s Pattern
53	IS 8157: 1976	Forceps, Granulation, Heath’s Pattern
54	IS 8191: 1976	Retractor, Pillar, Anterior and Tonsil Enucleator, Mollison’s Pattern
55	IS 8199: 1976	Tracheostomy Tubes, Fuller’s Pattern
56	IS 8315: 1977	Forceps, Redressing, Asch’s Pattern
57	IS 8316: 1977	Retractor, Hajek’s Pattern
58	IS 8327: 1977	Forceps, Nodule, Vocal, Chevalier Jackson’s Pattern
59	IS 8343: 1977	Forceps, Biopsy, Peterson’s Pattern
60	IS 8344: 1977	Snare, Aural, Glegg’s Pattern
61	IS 8734: 1978	Forceps, Cutting and Removing Large Specimens, Chevalier Jackson’s Pattern
62	IS 8735: 1978	Tube, Suction, Yankauer’s Pattern
63	IS 8743: 1994	ENT surgery instruments – Forceps, direct bronchoscopy, with alligator jaws and tenaculum points, Irwin Moore’s pattern
64	IS 8825: 1978	Specification for cannula, suction irrigation with locking device, micro laryngeal
65	IS 8837: 1978	Specification for suction tubes with stylet micro laryngeal surgery
66	IS 8838: 1978	Specification for forceps, cup, straight, micro laryngeal surgery
67	IS 8839: 1978	Specification for forceps, cup upwards, micro laryngeal surgery
68	IS 8840: 1978	Specification for scissors, micro-laryngeal surgery
69	IS 9014: 1979	Specification for Raspatory fine, curved right, Zoellner’s Pattern
70	IS 9015: 1979	Raspatory, Fine, Curved Left, Zoellner’s Pattern
71	IS 9016: 1979	Needle, Fine, Spear Pointed, Curved Right, Zoellner’s Pattern
72	IS 9017: 1979	Needle, Fine, Spear Pointed, Curved Left, Zoellner’s Pattern
73	IS 9058: 1979	Knife, Upward Cutting, Zoellner’s Pattern
74	IS 9059: 1979	Knife, Downward Cutting, Zoellner’s Pattern
75	IS 9060: 1979	Hook, Small, Zoellner’s Pattern
76	IS 9479: 1980	Specification for Hook, Fenestra, 25°, 45° and 90° Angle Ear, Shea’s Pattern
77	IS 9480: 1980	Elevators, Left and Right, Ear, Shea’s Pattern
78	IS 9526: 1980	Specification for scissors, stapedectomy, crocodile jaw
79	IS 9544: 1980	Specification for forceps, stapedectomy, round cup, elongated cup, and oval cup jaws
80	IS 9558: 1980	Specification for gauge, depth, PTFE (Teflon) piston
81	IS 9564: 1980	Specification for forceps, stapedectomy, serrated, smooth and Mc Gee wire closing jaws
82	IS 9718: 1981	Specification for jig, cutting, PTFE piston

How Will ELT Corporate Assist You With The BIS Certificate For Ear, Nose, And Throat Surgical Instruments?

ELT Corporate streamlines the BIS certification process for Ear, Nose, and Throat surgical instruments by managing all documentation, and legal requirements and ensuring compliance with GMP and regulatory standards. Our expertise ensures that the certification process is completed efficiently, minimizing delays and ensuring compliance.

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