The use of modular orthotic components of the lower limb plays an important role in the field of rehabilitation medicine, orthopaedics, and mobility aids for individuals with lower limb injuries. Components such as the ankle joint unit are extensively used in orthosis or prosthesis devices in order to ensure proper body functioning. Thus, it would be necessary for manufacturers to seek BIS Certification for Modular Lower Limb Orthotic Components Joint Ankle Unit, according to IS 9471 (Part 4):2024.
The Indian standard outlines the requirements for the mechanical strength, load-carrying capacity, joint performance, correct alignment, fatigue characteristics, corrosion protection and material properties. Meeting these parameters will help in assuring reliable functionality of the ankle joint units when subjected to repeated movements with different loads.
What is IS 9471 (Part 4):2024
This is the Indian Standard for modular lower limb orthotic components (ankle joint units) used in rehabilitation and medical prosthetic systems. The standard defines mechanical performance, movement control and material safety to ensure patient comfort and functional support. As per BIS, ankle joint orthotic components are:
- Tested for mechanical movement
- Evaluated for load-bearing capacity
- Assessed for material safety
- Checked for durability under repetitive motion
Who needs BIS Approval for Modular Orthotic Ankle Joint Units
BIS authorisation under IS 9471 (Part 4):2024 is required for businesses involved in manufacturing, importing, or supplying Modular Lower Limb Orthotic Components Ankle Joint units in India.
Applicable to:
- Manufacturers (India) - Must get BIS approval if the Lower Limb Orthotic Ankle Joint System are covered under QCO.
- Foreign Manufacturers - Need certification to export the Orthotic Ankle Joint Components to India.
- Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
- Sellers/Distributors - Should only sell certified Lower Limb Orthotic Ankle Joint Units.
BIS Testing Parameters for Modular Lower Limb Orthotic Ankle Joints
To ensure the safety and functional performance of modular lower limb orthotic ankle joint units, BIS defines requirements under IS 9471 (Part 4):2024. This certification ensures proper movement control, mechanical strength, and patient safety in rehabilitation and mobility support systems.
The BIS testing parameters and quality checks for orthotic ankle joint units are listed below:
BIS Certification Process for Modular Lower Limb Orthotic Ankle Joint Units
The BIS Authorisation process ensures that the Modular Lower Limb Orthotic Components Joint Ankle (IS 9471 (Part 4):2024) meet the required standards for safe, reliable and consistent performance. This certification process is governed by the Bureau of Indian Standards (BIS) and includes the following key steps:
- Online Registration: Manufacturers register on the BIS Manak portal by submitting company, factory, and product details. Foreign manufacturers must appoint an Authorized Indian Representative (AIR).
- Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for mechanical strength, joint articulation performance, load-bearing capability, dimensional accuracy, material quality, durability and corrosion resistance.
- Application Submission: The application is submitted along with test reports, technical documents, and factory details. Foreign manufacturers must also submit AIR-related documents.
- Factory Inspection: BIS officials visit the manufacturing facility to evaluate production processes, safety measures, and the quality control system.
- Grant of BIS License: After all compliance requirements are satisfactorily met, BIS grants the certification license under Scheme-I.
- Use of ISI Mark: Following approval, the manufacturer is authorized to use the ISI Mark on the product along with a valid CM/L number, confirming that the product meets BIS standards.
Checklist for BIS License Application under IS 9471 (Part 4):2024
| Document Category | Documents Required |
|---|
| Basic Details | GST Certificate, Email ID & Contact Number, Factory & Office Address, Rent Agreement / Lease Deed (if applicable),Partnership Deed (if applicable for partnership firms) |
| Manufacturing Details | List of Machinery, Process Flow Chart, Factory Layout Plan |
| Raw Material Details | List of Raw Materials, Supplier Details, Raw Material Invoices, Raw Material Test Certificates |
| Testing & Quality Control | List of Testing Equipment, Calibration Certificates, QC/Lab In-charge Appointment Letter & Qualification |
| Production Details | Annual Installed Capacity, Last Year Production Value |
| Product & Packaging Details | Quantity per Package, Nature of Packing, Product Printing / Marking Details |
| Management Details | Top Management Details, BIS Communication Contact Person |
| Brand & Certification Documents | Trademark / Brand Certificate, Consent Letter from BIS Recognized Laboratory |
| Additional Documents | Weekly Off Details, Hygiene Document (if applicable), Relaxation Letter (if applicable), Any Other Relevant Document |
| Foreign Manufacturer Requirement | Appointment of Authorized Indian Representative (AIR) for BIS coordination and compliance in India |
The Foreign manufacturers must designate an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and manages all compliance and regulatory requirements in India.
Product Marking Guidelines under IS 9471 (Part 4):2024
After obtaining the BIS licence, the ISI Mark for Modular Lower Limb Orthotic Components - Ankle Joint Unit must be applied clearly and permanently on the product and/or its packaging, as applicable. The marking shall also include essential details such as the manufacturer’s identification and the BIS licence number (CM/L). This ensures traceability and confirms compliance with prescribed quality and safety standards.
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 9471 (Part 4):2024 |
| CML Number | Certification Marks License (CML) number issued by BIS |
| Manufacturer Details | Name of manufacturer or registered trademark |
| Batch / Date | Batch number, heat number, or manufacturing date for traceability |
Note: Marking is typically applied using durable stamping, tagging, or permanent printing to ensure clear identification during handling, storage, and transportation, as per BIS marking requirements.
BIS License Validity under IS 9471 (Part 4):2024
| particulars | Details |
|---|
| Initial Validity | Typically 1 to 2 years, depending on BIS approval conditions |
| Renewal | Must be renewed before expiry by submitting the application along with the prescribed fee and updated documents |
| Surveillane | BIS may inspect factories and test samples periodically |
| Annual Fees | Annual license fee must be paid regularly |
| Compliance | Continuous compliance with BIS requirements is necessary |
| License Format | BIS is shifting towards a 10-digit license number format |
| Non-Compliance Risk | May lead to suspension or cancellation of license |
BIS Registration Cost for Modular Lower Limb Orthotic Ankle Joint Units
The cost involved in BIS certification of the Orthotic joint ankle component will include application fee, testing fee, factory inspection fee, license fee and marking fee. All these costs will be imposed by BIS based on Scheme-I of the BIS (Conformity Assessment) Regulations.
| Charge Type | Indian Manufacturers | Foreign Manufacturers |
|---|
| Application Fee | INR 1,000 | USD 15 |
| Audit Charges | INR 7,000 | USD 3,200 – 5,900 |
| License Fee | INR 1,000 | USD 15 |
| Marking Fee | As applicable | As applicable |
| Testing Charges | As applicable | As applicable |
| EVTL India Consultancy Fee | As per actual | As per actual |
Note:
- Application fee for foreign manufacturers is payable via SWIFT (SAARC countries may pay in INR with applicable GST).
- Audit charges for foreign manufacturers vary based on country/location.
- The marking fee is determined based on the product category and production volume (MSME benefits may apply).
- Testing charges are to be paid directly to BIS-recognised laboratories.
- Consultancy fees can vary depending on product type and factory location.
Conclusion
Modular Lower Limb Orthotic Components specifically the ankle joints, are frequently used in the field of orthosis and physical therapy. The reason behind this is that the ankle joint modular orthosis components contribute towards ensuring correct posture, weight distribution, stability and movement. Therefore, BIS Certification for Modular Lower Limb Orthotic Components - Ankle Joint Unit as per IS 9471 (Part 4):2024 would be vital to ensure that the product fulfills the criteria of quality, safety and effectiveness for medical purposes.
The following parameters have been specified in accordance with the guidelines of IS 9471 (Part 4):2024 and should be adhered to ensure effective functioning of the product. Some of these parameters include mechanical strength, load capacity, articulating capacity, fatigue strength, corrosion strength, dimensioning, and material quality, etc. BIS Certification on the mentioned standard will assist you in ensuring regulatory compliance and obtaining the necessary certifications from our team at EVTL India.
