BIS Certificate For Health Informatics

Health informatics is reshaping healthcare as we know it, offering smarter, faster, and more efficient ways to manage medical data and services. However, with this technology comes a big question how do you ensure these products are safe and reliable?

That’s where the BIS Certificate for Health Informatics comes in. It’s a mark of quality and compliance, required for products entering the Indian market. Whether you’re a manufacturer, importer, or distributor, this certification can make or break your success.

Let’s break it down so you know exactly what it’s about, why you need it, and how to get it. Let’s dive into the details to equip you with everything you need.

What Is BIS Certificate For Health Informatics?

The BIS certificate ensures that health informatics products meet India’s prescribed quality, safety, and performance standards. Health informatics involves software, systems, and technologies that manage and process healthcare data. From electronic health records (EHR) to telemedicine platforms, ensuring these solutions are reliable is critical.

By securing a BIS certification for Health Informatics, businesses demonstrate compliance with strict standards, instilling confidence in consumers and stakeholders alike.

Why Do You Need BIS Certification For Health Informatics?

There are multiple reasons why obtaining a BIS certification in health informatics is important.

• Regulatory Compliance: Indian regulations mandate BIS certification for specific products to protect end-users from substandard offerings.
• Market Access: Certification is crucial for product distribution, whether manufactured locally or imported.
• Consumer Trust: Certified products are perceived as safer and more reliable, helping you stand out in a competitive market.

Investing in a BIS certificate doesn’t just tick a compliance checkbox, it’s a strategic move to build a reputable brand.

Who Needs BIS Certificate For Health Informatics?

Any business involved in developing, manufacturing, or distributing health informatics products in India needs this certification.

• Manufacturers: Domestic and international manufacturers must obtain certification for their products to be sold in India.
• Importers: Those importing health informatics systems or devices must ensure compliance before bringing them into the country.
• Suppliers and Exporters: Businesses supplying certified products can gain a competitive edge by meeting Indian standards.

Whether you’re a small-scale startup or an established enterprise, obtaining a BIS certificate for health informatics is essential for regulatory and reputational reasons.

What Are The Importance Of Obtaining BIS Certification For Health Informatics?

Obtaining BIS Certificate for Health Informatics signifies that the product complies with Indian quality and safety standards. It ensures reliability, builds trust, and supports seamless market entry. Below, we explain the key benefits of obtaining BIS Certification for Health Informatics:

• Quality Assurance: BIS certification confirms that the health informatics system has passed rigorous testing to meet performance, safety, and accuracy standards. It guarantees the product’s reliability for healthcare applications.
• Regulatory Compliance: With a BIS certificate, health informatics products align with mandatory government regulations, ensuring smooth operations without legal challenges in the Indian market.
• Market Access: The certification enables manufacturers to sell health informatics products in India, opening up access to a growing market with diverse opportunities in healthcare technology.
• Consumer Confidence: Having the BIS mark on health informatics systems reassures healthcare providers and institutions that the product is safe, effective, and reliable.
• Export Opportunities: BIS certification enhances the appeal of health informatics products to international buyers, showcasing adherence to globally recognized quality benchmarks.
• Brand Credibility: The BIS mark reflects a commitment to quality, helping build a strong brand image in the competitive health informatics market.

Steps To Obtain BIS Certificate For Health Informatics

Here’s a simple guide to getting BIS certification for health informatics products:

• Log in to the BIS Portal: First, sign in to the BIS portal. You’ll need to create an account if you don’t have one.
• Generate Test Request: Once you’re logged in, generate a test request for your product. This is the first step to getting it officially tested.
• Get Your Product Tested: Your product needs to be tested at a BIS-recognized lab. The lab will check if your product meets the required standards.
• Verify the Test Report: After testing, you’ll receive a test report. Make sure to review it and verify the results.
• Apply on the Portal Within 90 Days: Once you have the test report, you must submit your application on the BIS portal within 90 days. Don’t miss this timeline!
• Submit the Required Documents: Along with your application, submit any necessary documents, such as technical specifications, safety reports, and anything else requested by BIS.

And that’s it! If everything goes smoothly, you’ll receive your BIS certificate for health informatics.

Documents Required For BIS Certification For Health Informatics

To obtain BIS certificate for health informatics products, you’ll need to submit a few important documents. Here’s a list of the typical documents required:

• Application form
• Product details and technical specifications
• Test reports from a BIS-recognized lab
• Quality Management System (QMS) documentation
• Compliance with relevant standards (IS or international)
• Manufacturer’s details
• Safety and performance reports
• Authorization or declaration letter (if applicable)

List Of Indian Standards Of BIS Certificate For Health Informatics

Here is a list of Indian Standards for BIS Certification in Health Informatics. Review the required standards below:

SI. No.	IS No.	TITLE
1	IS 10905: Part 1: 1984	Recommendations for basic requirements of general hospital buildings: Part 1 Administrative and hospital services department buildings
2	IS 10905: Part 2: 1984	Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings
3	IS 10905: Part 3: 1984	Recommendations for basic requirements of general hospital buildings: Part 3 Engineering services department buildings
4	IS 12377: 2016	Classification and matrix for various categories of hospitals (First Revision)
	(1 Revision)
5	IS 12433: Part 1: 1988	Basic requirements for hospital planning: Part 1 up to 30 bedded hospital
6	IS 12433: Part 2: 2001	Basic requirements for hospital planning: Part 2 up to 100 bedded hospital
7	IS 13808: Part 1: 1993	Quality management procedures for – Patient department (OPD) and emergency services – Guidelines: Part 1 up to 30 bedded hospitals
8	IS 13808: Part 2: 1993	Quality management procedures for diagnostic and blood transfusion services – Guidelines: Part 1 up to 30 – Bedded hospitals
9	IS 13808: Part 3: 1995	Quality management for hospital services (to 30 – Bedded Hospitals) – Guidelines: Part 3 wards, nursing services and operation theatre
10	IS 13808: Part 4: 1996	Quality management for hospital services (For 30 – Bedded Hospital) – Guidelines: Part 4 hospital support services
11	IS 13808: Part 5: 1996	Quality management for hospital services (For 30 – Bedded Hospital) – Guidelines: Part 5 hospital equipment management
12	IS 15195: 2002	Performance guidelines for quality assurance in hospital services up to 30 – Bedded hospitals
13	IS 15461: 2004	Performance guidelines for quality assurance in hospital services up to 100 – Bedded hospitals
14	IS 15551: 2003	Quality management systems – Guidelines for process improvements in health service organizations
15	IS 15784: 2007	Healthcare facilities – Particular requirements
16	IS 15902: 2011	Guidelines For Nursing Home
17	IS 15903: 2010	Guidelines For Maternity Nursing Home
18	IS 15904: 2011	Guidelines For Single Doctor Clinic–Including Dental Clinic
19	IS 17722: 2021/ISO/TS 22583:2019	Guidance for supervisors and operators of point-of-care testing POCT devices
20	IS 17723: 2021/ISO 22870:2016	Point-of-care testing POCT Requirements for quality and competence
21	IS 23485: 2019	Medical devices – Quality management system requirements and essential principles of safety and performance for medical devices
22	IS/IEC 62366 : Part 1 : 2015/IEC 62366-1:2015	Medical Devices Part 1 Application of Usability Engineering to Medical Devices
23	IS/IEC 80369 : Part 5 : 2016/IEC 80369-5:2016	Small-bore connectors for liquids and gases in healthcare applications Part 5 Connectors for limb cuff inflation applications
24	IS/IEC 80369: Part 6: 2016/ISO 80369-6:2016	Small bore connectors for liquids and gases in healthcare applications Part 6 Connectors for neuraxial applications
25	IS/IEC/TR 62366: Part 2 :2016/IEC/TR 62366-2:2016	Medical Devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices
26	IS/ISO 13485: 2016/ISO 13485:2016	Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )
	(1 Revision)
27	IS/ISO 14971: 2019/ISO 14971 :2019	Medical devices – Application of risk management to medical devices First Revision
	(1 Revision)
28	IS/ISO 15189: 2012/ISO 15189 :2012	Medical laboratories – Requirements for quality and competence (Second Revision)
	(2 Revision)
29	IS/ISO 15190: 2003/ISO 15190:2003	Medical Laboratories — Requirements for Safety
30	IS/ISO 15195: 2018/ISO 15195:2018	Laboratory Medicine — Requirements for the Competence of Calibration Laboratories Using Reference Measurement Procedures
31	IS/ISO 15197: 2013/ISO 15197 :2013	In vitro Diagnostic Test Systems —Requirements for Blood-GlucoseMonitoring System for Self-Testingin Managing Diabetes Mellitus
	(1 Revision)
32	IS/ISO 15198: 2004/ISO 15198:2004	Clinical Laboratory Medicine — In vitro Diagnostic Medical Devices — Validation of User Quality Control Procedures by the Manufacturer
33	IS/ISO 15223: Part 1: 2016	Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision )
	(2 Revision)
34	IS/ISO 15223: Part 2: 2010/ISO 15223-2: 2010	Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation
35	IS/ISO 16142: Part 1: 2016/ISO 16142-1: 2016	Medical Devices — Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards
36	IS/ISO 16142: Part 2 :2017/IS/ISO 16142-2: 2017	Medical devices – Recognized essential principles of safety and performance of medical devices: Part 2 General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
37	IS/ISO 17511: 2020/ISO 17511:2020	In Vitro Diagnostic Medical Devices – Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials and Human Samples
38	IS/ISO 17822: Part 1: 2014/ISO 17822-1: 2014	In vitro diagnostic test systems – Qualitative nucleic acid – Based in vitro examination procedures for detection and identification of microbial pathogens: Part 1 general requirements, terms and definitions
39	IS/ISO 18250: Part 1: 2018/ISO 18250-1:2018	Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 1 General requirements and common test methods
40	IS/ISO 18250: Part 3: 2018/ISO 18250-3:2018	Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 3 Enteral Applications
41	IS/ISO 18250: Part 6: 2019/ISO 18250-6:2019	Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 6 Neural Applications
42	IS/ISO 18250: Part 7: 2018/ISO 18250-7:2018	Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 7 Connectors for intravascular infusion
43	IS/ISO 18250: Part 8: 2018/ISO 18250-8:2018	Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 8 Citrate-based anticoagulant solution for apheresis applications
44	IS/ISO 20776: Part 1: 2019/ISO 20776-1:2019	Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 1 Broth Micro-Dilution Reference Method for Testing the in vitro Activity of Antimicrobial Agents Against Rapidly Growing Aerobic Bacteria Involved in Infectious Diseases
45	IS/ISO 20776: Part 2: 2007/ISO 20776-2:2007	Clinical Laboratory Testing and In-vitro Diagnostic Test Systems — Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 2 Evaluation of Performance of Antimicrobial Susceptibility Test Devices
46	IS/ISO 23640: 2011/ISO 23640 :2011	In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents
47	IS/ISO 35001: 2019/ISO 35001:2019	Biorisk management for laboratories and other related organisations
48	IS/ISO 62304: 2015/ISO 62304 :2015	Medical device software – Software life cycle processes
49	IS/ISO 80369: Part 1: 2018/ISO 80369-1:2018	Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements
50	IS/ISO/TR 24971: 2013/ISO/TR 24971: 2013	Medical devices – Guidance on the application of ISO 14971
51	IS/ISO/TR 80002: Part 2 :2017/ISO/TR 80002-2:2017	Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems
52	IS/ISO/TS 20658: 2017/ISO/TS 20658:2017	Medical Laboratories – Requirements for Collection, Transport, Receipt, and Handling of Samples
53	IS/ISO/TS 22367: 2008/ISO/TS 22367:2008	Medical Laboratories – Reduction of Error through Risk Management and Continual Improvement

What Happens If You Don’t Obtain BIS Certification For Health Informatics?

If you don’t get BIS Certificate for health informatics products, it can cause several problems. First, you won’t be able to sell your products legally in the Indian market, which could restrict your business growth. Regulatory authorities might also impose fines or take legal action against your company for non-compliance.

Additionally, customers may hesitate to trust your product without a certification, as it indicates a lack of quality or safety checks. This can hurt your reputation and make it harder to compete with certified products. In short, skipping BIS certification can lead to lost opportunities, legal troubles, and damage to your brand’s credibility.