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:
- Any manufacturer who wants to sell medical electrical equipment can apply for BIS Certification.
- Importers who wish to market and sell medical electrical equipment in India can apply for BIS Certification.
- 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:
- Log into the BIS online portal.
- Fill out the BIS Certification Application form.
- Submit all required documents, including test reports from a BIS-approved lab, product specifications, and user manuals.
- Manufacturing site inspection by BIS officials.
- A thorough review of the application and supporting documents.
- Generation of a performance report by authorities.
- Upon successful review and verification, the BIS license is issued.
- 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:
- Completed application form
- Applicant’s personal information
- Product specifications and details
- Proof of manufacturing or business establishment
- Valid manufacturing license
- Product test reports from an accredited lab
- Facility/site layout
- MSME/SSI certification, if applicable
- List of equipment or instruments in use
- Calibration certificates
- Fee payment receipt
- Power of attorney, if required
- 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.
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.