What is Bureau of Indian Standards?
Bureau of Indian Standards (BIS) is an India body of standards which is formed under the BIS Act 2016. It is operated by the Ministry of Consumer Affairs, Food & Public Distribution, Government of India and the activities of BIS are:
- Formulation of Standards
- International Activities
- Product Certification
- Hallmarking
- Laboratory Services
- Training Services - National Institute of Training for Standardisation
- Consumer Affairs and Publicity
BIS certification provides assurance to customers about product quality and reliability and safety. With its conformity assessment and activity of standardization, it ensures safe, reliable and quality of products; checks on hazardous products; protects environment; promotes exports & imports; etc. In general, certification of product under BIS is voluntary but certain products have been notified by Government of India which need compulsory registration with an aim to promote safety of people of India.
BIS in the Medical Industry
In the last several years, the medical industry has witnessed exponential growth and various innovative & technology advanced medical equipment being launched both in India and around the globe. It was a very unregulated market in India with no authority to confirm the quality & safety of the products. The large increase in export and import of equipment has prompted Government of India to bring various medical products under the umbrella of the BIS.
It ensures that the medical products are according to the standards set by the authority, and the certification assures that the equipment is safe to use. It ensures that the products which are manufactured meet Indian specific standards, quality, reliability and performance. It provides authenticity to the products which helps businesses to gain trust among the customers.
Medical Equipment
Ministry of Chemicals and Fertilizers with vide Public Notice dated 01.02.2022 has issued the list of medical devices to be registered under BIS are notified. In the notice, it is specifically mentioned that the products standards should be as per Rule 7 of Medical Device Rules, 2017. BIS has prescribed Indian Standard (IS) for 1485 medical devices/equipment under the following categories.
- Category 1: Surgical Instruments (MHD-01)
- Category 2: Orthopaedic Instruments, Implants And Accessories (MHD-02)
- Category 3: Obstetric And Gynaecological Instruments And Appliances (MHD-03)
- Category 4: Ear, Nose And Throat Surgery Instruments (MHD-04)
- Category 5: Ophthalmic Instruments And Appliances (MHD-05)
- Category 6: Thoracic And Cardiovascular Surgery Instruments (MHD-06)
- Category 7: Neurosurgery Instruments Implants And Accessories (MHD-07)
- Category 8: Dentistry (MHD-08)
- Category 9: Artificial Limbs, Rehabilitation Appliances and Equipment for the Disabled (MHD-09)
- Category 10: Medical Laboratory Instruments (MHD-10)
- Category 11: Anaesthetic, Resuscitation And Allied Equipment (MHD-11)
- Category 12: Hospital Equipment and Surgical Disposal (MHD-12)
- Category 13: Veterinary Hospital Planning And Surgical Instruments (MHD-13)
- Category 14: Hospital Planning (MHD-14)
- Category 15: Electromedical Diagnostic Imaging and Radiotherapy equipment (MHD-15)
- Category 17: Health Informatics (MHD-17)
- Category 19: Biological Evaluation of invitro Diagnostic Medical Devices (MHD-19)
- Category 20: Medical Biotechnology And Nanotechnology (MHD-20)
- Category 23: Anatomy and Forensic Sciences Equipment (MHD-23)
Key Features of BIS Certification
- Who are required to opt for BIS: It is mandatory for all manufacturers and importers of medical devices to get medical products certified from BIS. It gives a proof that the medical devices are following Indian standards for safety and quality.
- Timeline for grant of license under BIS: Depending upon the nature of product, the time taken for grant of license is in between 1 -4 months from the date of receipt of complete application and its recording.
- Validity: The validity of BIS registration of medical devices is generally 2 years and the license can be renewed for a period of up to 5 years.
Benefits of BIS Certification
- Quality Assurance:BIS Certification for Medical Devices guarantees that medical products meet established safety and quality standards. The certification provides third-party assurance about medical product reliability and quality and safety. Medical devices need this certification for mandatory compliance.
- Build Trust: The registration of medical devices under BIS Certificate helps build consumer trust for the product while establishing brand reputation in the market. It also helps in developing your brand reputation.
- Regulatory Compliance: BIS Registration is compulsory in the Quality Control Orders, a regulation introduced by government of India for certain medical devices.
- Market Growth: Products with BIS Certification for Medical Devices gain more market reliability than other brands without this certification.
How to Get BIS Certification for Medical Devices?
The steps to be followed to obtain BIS Certification for Medical Device are: -
- Registering or Login by Creating an account in BIS portal
- Filling the Application
- Completing the Application form as per BIS guidelines
- Attaching Documents: Laboratory test reports and other documentary evidence
- Submitting the Application by paying a requisite fee
Documents required in BIS Certification for Medical devices
The list of documents which are required to be filed along with the BIS registration application: -
- Proof of Registered Address
- Proof of Trademark
- Product Manual of the products
- Testing Documents
- ISO certificate of the manufacturer
- List of machines used at Premise
- Trademark Certificate
- Manufacturing Process Flow chart
- Test Report from Laboratory
How SKMC Global Can Help?
We SKMC Global as a Service provider plays a vital role in helping companies navigate the BIS registration process by offering end-to-end support from understanding applicable standards and preparing documentation to coordinating product testing and managing regulatory interactions. Our expertise reduces the complexity of the BIS certification process, ensuring that products meet Indian regulatory requirements and can be legally sold in the Indian market. This partnership enables businesses to achieve compliance more efficiently and effectively.