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
1IS 10157: 1982Percussor, Neurological, McGill’s Pattern
2IS 10172: 1982Specification for burs and perforators for drill brace
3IS 10174: 1982Tongs, skull Traction, Crutchfield’s Pattern
4IS 10183: 1982Specification for retractor, deep, self – Retaining, laminectomy
5IS 10676: 1983Spatula, Brain, Double-ended Malleable, Olivecrona’s Pattern
6IS 10677: 1983Specification for rongeur, intervertebral disk
7IS 10765: 1983Forceps, Dissecting, Toothed and Bayonet Shaped, Cushing’s Pattern
8IS 13141: 1991Neurosurgical Instruments-Leksell’s Rongeur
9IS 13175: 1991Neurosurgical instruments – Needle holder – Shape and dimensions
10IS 13180: 1991Neurosurgical instruments – Scoville trephine – Specification
11IS 14139: 2008Neurosurgical implants – Self – Closing intracranial aneurysm clips (First Revision)
12IS 14679: 1999Neurosurgical implants – Implantable peripheral nerve stimulators
13IS 17744: 2021/16054:2019Implants for surgery Minimum data sets for surgical implants
14IS 8174: 1994Neurosurgical instruments – Forceps, artery, Dandy’s pattern – Shape and dimensions – First Revision
15IS 8175: 1994Neurosurgical Instruments – Forceps, Artery, Straight and Curved on Flat, Hugh Cairn’s Pattern – Shape and Dimensions (First Revision)
16IS 8176: 1976Dissectors, Penfield’s Pattern
17IS 8334: 1977Rongeur, Cranial, Dahlgren’s Pattern
18IS 8380: 1977Rongeur, Double-Action, Olivecrona’s Pattern
19IS 8695: 1978Forceps, Dressing, Bayonet Shape, Cushing’s Pattern
20IS 8696: 1978Guide, Saw, De Martel’s Pattern
21IS 8799: 1978Specification for rongeur, kerrison
22IS 9041: 1979Specification for elevator, periosteal
23IS 9072: 1979Specification for rongeur, pituitary
24IS 9073: 1979Specification for neuro – Suction tubes
25IS 9074: 1979Specification for raney clips and clip applicator
26IS 9408: 1986Specification for retractor, self-retaining (First Revision)
27IS 9410: Part 1: 1980Specification for silver clip set: Part 1 forceps, clip cutting and forming
28IS 9410: Part 2: 1980Specification for silver clip set: Part 2 forceps, clip applying
29IS 9410: Part 3: 1981Specification for silver clip set: Part 3 rack, clip
30IS 9903: 1981Specification for brace, skull
31IS 9904: 1981Specification for hooks, dural
32IS 9911: 1981Specification for cannula, brain
33IS 9914: 1981Calipers, Ice Tong, Cone’s Pattern
34IS 9933: 1981Specification for retractor, brain, malleable
35IS/ISO 13175: Part 3: 2012/ISO 13175-3Implants for surgery – Calcium phosphates: Part 3 hydroxyapatite and beta – Tricalcium phosphate bone substitutes
36IS/ISO 13179: Part 1: 2014/ISO 13179: 2014Implants for Surgery Plasma Sprayed Unalloyed Titanium Coatings on Metallic Surgical Implants Part 1 General Requirements
37IS/ISO 13779: Part 3: 2018/ISO 13779-3:2008Implants for surgery – Hydroxyapatite: Part 3 chemical analysis and characterization of crystallinity and phase purity
38IS/ISO 13779: Part 4: 2018/ISO 13779-4: 2002Implants for surgery – Hydroxyapatite: Part 4 determination of coating adhesion strength
39IS/ISO 13779: Part 6: 2015/ISO 13779-6: 2015Implants for surgery – Hydroxyapatite: Part 6 powders
40IS/ISO 14708: Part 1: 2014/ISO 14708-1:2014Implants for surgery – Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)
41IS/ISO 14708: Part 3: 2017/ISO 14708-3:2017Implants for surgery – Active implantable medical devices: Part 3 implantable neurostimulators (First Revision)
42IS/ISO 14708: Part 7: 2013/ISO 14708-7:2013Implants for surgery – Active implantable medical devices: Part 7 particular requirements for cochlear implant systems
43IS/ISO 16402: 2008/ISO 16402:2008IS/ISO 15309: 2013/ISO 15309:2013
44IS/ISO 16402: 2008/ISO 16402 :2008Implants for surgery – Acrylic resin cement – Flexural fatigue testing of acrylic resin cement used in orthopaedics
45IS/ISO 17327: Part 1: 2018Non-active surgical implants Implant coating Part 1: General requirements
46IS/ISO 19227: 2018Implants for Surgery – Cleanliness of Orthopedic Implants – General Requirements
47IS/ISO 7197: 2006Neurosurgical implants – Sterile, singleuse hydrocephalus shunts and components
48IS/ISO 9583: 1993implants for Surgery Non-Destructive Testing – Liquid Penetrant Inspection of Metallic Surgical Implants
49IS/ISO 9584: 2021Implants for Surgery – Non-Destructive Testing – Radiographic Examination of Cast Metallic Surgical Implants
50IS/ISO/IEEE 11073: Part 20101: 2004/ISO/IEEE 11073-20101: 2004Health informatics – Point-of-care medical device communication: Part 20101 application profiles – Base standard
51IS/ISO/TR 14283: 2018Implants for Surgery – Essential Principles of Safety and Performance
52IS/ISO/TS 10974: 2018/ISO 10974: 2018Assessment 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.

Is BIS Certificate Mandatory For Neurosurgery Instruments And Implants?

Yes, a BIS certificate is required for all neurosurgical instruments, implants, and accessories in India.

What If My Application For BIS Certificate Is Rejected?

If your application is rejected, BIS will offer feedback on the reasons. ELT Corporate can assist in addressing these issues and help you resubmit the application effectively.

× Need Help?