BIS Certificate For Neurosurgery Instruments, Implants And Accessories

If you want to manufacture, import, distribute, or sell medical devices like Neurosurgery instruments Implants, And Accessories in India then getting a Bureau of Indian Standards Certificate is mandatory as per BIS Act 2016.

Neurosurgery instruments, Implants, And Accessories play an essential role in the safety and success of intricate surgical procedures involving the brain, spine, and nervous system. This is where the BIS certificate becomes vital.

At ELT corporate, we assist in granting BIS Certificate for Neurosurgery instruments Implants, And Accessories with our deep regulatory expertise. We provide comprehensive support and make the process smooth. Let’s be regulatory partners in achieving your goals.

What Is BIS Certification For Neurosurgery Instruments Implants And Accessories?

A BIS Certificate for Neurosurgery Instruments, Implants, and Accessories is a mandatory certification in India that ensures these medical devices comply with national safety, quality, and performance standards.

BIS certification acts as a third-party validation of the product’s adherence to safety guidelines, helping to maintain trust among healthcare professionals and patients.

What Are Neurosurgery Instruments Implants And Accessories?

Neurosurgery instruments and implants are specialized tools used in surgeries on the brain, spine, and nervous system. These tools help surgeons perform complex procedures like brain surgeries (craniotomies), spine stabilization (spinal fusions), and repairing blood vessels in the brain (aneurysm repairs).

Common instruments include scalpels, forceps, and retractors. Implants, such as spinal screws, plates, and stents, are used to support or replace damaged areas in the nervous system. Additionally, accessories like clamps, holders, and guides provide essential support to ensure accuracy and stability during surgery.

Who Can Apply For BIS Certificate For Neurosurgery Instruments Implants And Accessories?

The following person or individual can apply for a BIS Certification for Neurosurgery Instruments, Implants, and Accessories:

1. Any manufacturer who wants to sell medical electrical equipment can apply for BIS Certification.
2. Importers who wish to market and sell medical electrical equipment in India can apply for BIS Certification.
3. An authorized person can apply for a BIS certificate on behalf of the manufacturer, importer, or foreign manufacturer or importer.

What Are The Benefits Of Obtaining BIS Certification For Neurosurgery Instruments Implants And Accessories?  

Here are the key benefits of obtaining a BIS Certificate for Neurosurgery Instruments, Implants, and Accessories :

• Guarantees product quality and safety through comprehensive testing.
• Increases global recognition and credibility.
• Opens up new market opportunities.
• Demonstrates high product quality via the ISI Mark.
• Builds consumer confidence and trust in the brand.
• Ensures adherence to regulatory standards.
• Minimizes risks of market recalls or product rejections.

Procedure For Obtaining BIS Certificate For Neurosurgery Instruments Implants And Accessories

To obtain a BIS certificate for Neurosurgery Instruments, Implants, and Accessories follow this essential step:

1. Log into the BIS online portal.
2. Fill out the BIS Certification Application form.
3. Submit all required documents, including test reports from a BIS-approved lab,  product specifications, and user manuals.
4. Manufacturing site inspection by BIS officials.
5. A thorough review of the application and supporting documents.
6. Generation of a performance report by authorities.
7. Upon successful review and verification, the BIS license is issued.
8. Participate in regular BIS audits to maintain compliance.

Document Required For BIS Certificate For Neurosurgery Instruments, Implants, And Accessories

Here’s the list of documentation required for the BIS certificate for Neurosurgery Instruments, Implants, and Accessories:

1. Completed application form
2. Applicant’s personal information
3. Product specifications and details
4. Proof of manufacturing or business establishment
5. Valid manufacturing license
6. Product test reports from an accredited lab
7. Facility/site layout
8. MSME/SSI certification, if applicable
9. List of equipment or instruments in use
10. Calibration certificates
11. Fee payment receipt
12. Power of attorney, if required
13. Additional documents as specified by BIS standards

Validity Of BIS Certificate For Neurosurgery Instruments, Implants, And Accessories

The BIS Certificate for Neurosurgery Instruments, Implants, and Accessories is valid for one year from the date of issuance. After this period, the license can be renewed within the specified timeframe; otherwise, a fine of Rs. 5,000 may be imposed.

Timeline For Obtaining BIS Certification For Neurosurgery Instruments, Implants, And Accessories

The timeline for obtaining a BIS Certificate for Neurosurgery Instruments, Implants, and Accessories in India generally falls between 30 to 40 days, though this can vary depending on product complexity and the thoroughness of the application submitted.

List Of Indian Standards Of BIS For Neurosurgery Instruments, Implants, And Accessories

SI. No.	IS No.	TITLE
1	IS 10157: 1982	Percussor, Neurological, McGill’s Pattern
2	IS 10172: 1982	Specification for burs and perforators for drill brace
3	IS 10174: 1982	Tongs, skull Traction, Crutchfield’s Pattern
4	IS 10183: 1982	Specification for retractor, deep, self – Retaining, laminectomy
5	IS 10676: 1983	Spatula, Brain, Double-ended Malleable, Olivecrona’s Pattern
6	IS 10677: 1983	Specification for rongeur, intervertebral disk
7	IS 10765: 1983	Forceps, Dissecting, Toothed and Bayonet Shaped, Cushing’s Pattern
8	IS 13141: 1991	Neurosurgical Instruments-Leksell’s Rongeur
9	IS 13175: 1991	Neurosurgical instruments – Needle holder – Shape and dimensions
10	IS 13180: 1991	Neurosurgical instruments – Scoville trephine – Specification
11	IS 14139: 2008	Neurosurgical implants – Self – Closing intracranial aneurysm clips (First Revision)
12	IS 14679: 1999	Neurosurgical implants – Implantable peripheral nerve stimulators
13	IS 17744: 2021/16054:2019	Implants for surgery Minimum data sets for surgical implants
14	IS 8174: 1994	Neurosurgical instruments – Forceps, artery, Dandy’s pattern – Shape and dimensions – First Revision
15	IS 8175: 1994	Neurosurgical Instruments – Forceps, Artery, Straight and Curved on Flat, Hugh Cairn’s Pattern – Shape and Dimensions (First Revision)
16	IS 8176: 1976	Dissectors, Penfield’s Pattern
17	IS 8334: 1977	Rongeur, Cranial, Dahlgren’s Pattern
18	IS 8380: 1977	Rongeur, Double-Action, Olivecrona’s Pattern
19	IS 8695: 1978	Forceps, Dressing, Bayonet Shape, Cushing’s Pattern
20	IS 8696: 1978	Guide, Saw, De Martel’s Pattern
21	IS 8799: 1978	Specification for rongeur, kerrison
22	IS 9041: 1979	Specification for elevator, periosteal
23	IS 9072: 1979	Specification for rongeur, pituitary
24	IS 9073: 1979	Specification for neuro – Suction tubes
25	IS 9074: 1979	Specification for raney clips and clip applicator
26	IS 9408: 1986	Specification for retractor, self-retaining (First Revision)
27	IS 9410: Part 1: 1980	Specification for silver clip set: Part 1 forceps, clip cutting and forming
28	IS 9410: Part 2: 1980	Specification for silver clip set: Part 2 forceps, clip applying
29	IS 9410: Part 3: 1981	Specification for silver clip set: Part 3 rack, clip
30	IS 9903: 1981	Specification for brace, skull
31	IS 9904: 1981	Specification for hooks, dural
32	IS 9911: 1981	Specification for cannula, brain
33	IS 9914: 1981	Calipers, Ice Tong, Cone’s Pattern
34	IS 9933: 1981	Specification for retractor, brain, malleable
35	IS/ISO 13175: Part 3: 2012/ISO 13175-3	Implants for surgery – Calcium phosphates: Part 3 hydroxyapatite and beta – Tricalcium phosphate bone substitutes
36	IS/ISO 13179: Part 1: 2014/ISO 13179: 2014	Implants for Surgery Plasma Sprayed Unalloyed Titanium Coatings on Metallic Surgical Implants Part 1 General Requirements
37	IS/ISO 13779: Part 3: 2018/ISO 13779-3:2008	Implants for surgery – Hydroxyapatite: Part 3 chemical analysis and characterization of crystallinity and phase purity
38	IS/ISO 13779: Part 4: 2018/ISO 13779-4: 2002	Implants for surgery – Hydroxyapatite: Part 4 determination of coating adhesion strength
39	IS/ISO 13779: Part 6: 2015/ISO 13779-6: 2015	Implants for surgery – Hydroxyapatite: Part 6 powders
40	IS/ISO 14708: Part 1: 2014/ISO 14708-1:2014	Implants for surgery – Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)
41	IS/ISO 14708: Part 3: 2017/ISO 14708-3:2017	Implants for surgery – Active implantable medical devices: Part 3 implantable neurostimulators (First Revision)
42	IS/ISO 14708: Part 7: 2013/ISO 14708-7:2013	Implants for surgery – Active implantable medical devices: Part 7 particular requirements for cochlear implant systems
43	IS/ISO 16402: 2008/ISO 16402:2008	IS/ISO 15309: 2013/ISO 15309:2013
44	IS/ISO 16402: 2008/ISO 16402 :2008	Implants for surgery – Acrylic resin cement – Flexural fatigue testing of acrylic resin cement used in orthopaedics
45	IS/ISO 17327: Part 1: 2018	Non-active surgical implants Implant coating Part 1: General requirements
46	IS/ISO 19227: 2018	Implants for Surgery – Cleanliness of Orthopedic Implants – General Requirements
47	IS/ISO 7197: 2006	Neurosurgical implants – Sterile, singleuse hydrocephalus shunts and components
48	IS/ISO 9583: 1993	implants for Surgery Non-Destructive Testing – Liquid Penetrant Inspection of Metallic Surgical Implants
49	IS/ISO 9584: 2021	Implants for Surgery – Non-Destructive Testing – Radiographic Examination of Cast Metallic Surgical Implants
50	IS/ISO/IEEE 11073: Part 20101: 2004/ISO/IEEE 11073-20101: 2004	Health informatics – Point-of-care medical device communication: Part 20101 application profiles – Base standard
51	IS/ISO/TR 14283: 2018	Implants for Surgery – Essential Principles of Safety and Performance
52	IS/ISO/TS 10974: 2018/ISO 10974: 2018	Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device

How ELT Corporate Will Assist You With BIS Certificate For Neurosurgery Instruments, Implants, And Accessories?  

At, ELT corporate we are here to help you at every single step of getting a BIS certificate for Neurosurgery Instruments, Implants, and Accessories. Whether you need any guidance or support in regulatory compliance, labelling, or licensing, our expert team will help you with a smooth and seamless process. Let’s get in touch with us to turn your business into a successful one.