BIS for Medical Devices

1. ●BIS for medical devices is mandatory in India and highlights the safety and quality of medical devices for a patient. ●Companies must take care to go through precise testing and certification. ● This guide explains everything—from registration to compliance—for both local and international brands. BIS for Medical Devices: A Complete Compliance Guide for 2025 Real Story: When a Shipment of an Imported Ventilator was Stopped at Port In early 2024, an organization based in Mumbai was importing high-end ventilators from Germany. This shipment was detained at Nhava Sheva harbour. Reason? No BIS certification. The importer was unaware that medical devices like ventilators now fall under the mandatory BIS scope. A 45-day delay not only impacted hospital supply chains but also caused serious financial losses. This is not an isolated incidence. With India's regulatory body gaining momentum to control and provide standards on the quality of medical devices, continue reading for a better understanding of what to expect—unless companies can remediate their import and register for certification for BIS, there will be more delays. What is BIS Certification for Medical Devices? The Bureau of Indian Standards (BIS) is the national standards body created by an act of Parliament of the Ministry of Consumer Affairs, Government of India. The organization exists to maintain standards of quality, quantity, safety and reliability in products through systematic scheme of certifications. When it comes to medical devices, BIS certification is a regulatory necessity for an expanding array of devices under the Compulsory Registration Scheme (CRS) or ISI Mark Scheme, depending on device type. Which Medical Devices Require BIS Certification?

2. BIS certification becomes mandatory after 2025 for multiple categories of medical devices.Here's a quick Category Common Devices Diagnostic X-ray machines, ECG monitors, ultrasound scanners Therapeutic Infusion pumps, ventilators, defibrillators Surgical Electrosurgical units, suction machines Home-Use Glucometers, nebulizers, digital BP monitors BIS Schemes for Medical Devices: ISI vs CRS There are two types of certification routes under BIS, depending on the nature of the medical device: 1. ISI Mark Scheme (Product Certification Scheme) ●Pertains to critical devices such as surgical instruments, life-saving devices ● Requires factory inspection, type testing in BIS-approved labs, and regular surveillance ● Marked with the iconic ISI logo 2. CRS (Compulsory Registration Scheme) ●Pertains to electronic / home-use medical devices ● Involves self-declaration, lab testing, and no factory audit ● Faster process, generally 3–5 weeks Process to Obtain BIS for Medical Devices Here’s a detailed roadmap for certification under both schemes:

3. Step 1: Classification & Standard Identification ●Identify the applicable Indian Standard (IS) (for example, IS 13450 for electrosurgical units) ● Verify if the product falls under ISI or CRS Step 2: Select BIS-Recognized Lab ● Samples must be tested in a BIS-approved lab ● The lab issues a test report in accordance with relevant IS standard Step 3: Application on BIS Portal ● Register on www.manakonline.in ● Submit Form VI (for ISI) or online CRS form with test report and documents Step 4: Factory Audit (only ISI scheme) ● A BIS officer will visit the factory (India or abroad) to verify compliance ● Inspection includes raw material checks, manufacturing process, and QC systems Step 5: Grant of License ● If all conditions are met, BIS grants the license for a specific product and location ● You can then affix the ISI mark or CRS logo on packaging and marketing material Documents Required for BIS Certification Ensure these are ready before submission: ● Product test report (from BIS-recognized lab) ● Factory license & layout ● Brand ownership documents

4. ● ISO 13485 or ISO 9001 certificate (recommended) ●Authorization letter (if applicant ≠ manufacturer) ● Indian agent details (for foreign manufacturers) How We Helped a Chennai-Based Diagnostic Equipment Importer A diagnostic firm importing portable ultrasound machines from South Korea faced repeated BIS rejections due to minor labeling errors and an unapproved lab test. When they consulted us at Diligence Certification, we reviewed their documents, fixed technical gaps, and coordinated directly with a BIS-recognized lab in Bengaluru. BIS license was granted within 32 days—without any audit rescheduling or fines. Why BIS for Medical Devices Matters 1. Compliance Risk: Risk of port seizure and penalties under Legal Metrology and Drugs & Cosmetics Acts. 2. Brand Trust: Hospitals, clinics, and most government buying institutions only buy products that are BIS-marked. 3. Market Expansion: With BIS, your products become eligible for e-tendering, export incentives, and institutional purchase. 4. Patient Safety: BIS ensures adherence to precision, performance, and safety— essential in healthcare. Common Challenges and How to Avoid Them Issue Fix Delay in lab testing Choose BIS-recognized labs with track records Rejection due to incomplete documents Double-check brand ownership and test report formats

5. Misclassification Consult experts before selecting IS standards Agent mismatch (for foreign firms) Appoint BIS-authorized Indian rep with Power of Attorney Common Pitfalls and Considerations Given India is a rapidly growing healthcare market, where patient life may often depend on device precision, obtaining BIS for medical devices is not just a legal requirement, but a business requirement. If you are contemplating manufacture or import of medical devices, ensure that the requirement to comply with the requirements of the BIS before commercialisation of your product forms part of your product launch strategy. A little delay today, could save you a lost sale or two tomorrow. Need help navigating the BIS maze? Contact Diligence Certification today and get started with a free compliance check. Need assistance with your BIS for Medical Devices We are just one call away! Call Us: +919471642921 Visit: https://www.diligencecertification.com/bis-for-medical-devices/ Need Help? Contact Diligence Certification We handle everything—from testing to approval. Talk to our compliance team for a hassle-free experience. Website: https://www.diligencecertification.com/ Phone: +919471642921 Get Download More Free Compliance Guides at https://www.diligencecertification.com/