BIS ISI MARK CERTIFICATION FOR MEDICAL PRODUCTS

What is BIS ISI Mark Certification for Medical Products?

BIS ISI Mark certification for medical products is a mandatory quality compliance requirement introduced under various Quality Control Orders issued by the Government of India. It ensures that medical products comply with applicable Indian Standards for safety, performance, hygiene, and reliability before they are manufactured, sold, or imported into the Indian market.

The ISI Mark signifies that a medical product has undergone testing, factory inspection, and conformity assessment as per Bureau of Indian Standards (BIS) guidelines. Certified products are subject to ongoing surveillance to maintain consistent quality, helping prevent substandard medical supplies from reaching hospitals, clinics, and patients.

Commonly regulated medical products include surgical instruments, gloves, syringes, needles, hospital furniture, disposable medical items, and select medical devices used in routine healthcare settings. BIS ISI Mark certification applies to both Indian and foreign manufacturers supplying medical products to India, and compliance is essential to avoid legal penalties and market restrictions.

Benefits of BIS CRS Registration for Medical Products

BIS CRS (Compulsory Registration Scheme) registration is a mandatory regulatory requirement in India for medical products that contain electronic or electrical components. While the ISI Mark scheme applies to conventional medical items, CRS registration specifically covers electronic medical devices and components regulated under the Electronics and IT Goods (Requirement for Compulsory Registration) Order. Apart from legal compliance, CRS registration offers multiple operational and commercial benefits for manufacturers and importers.

1. Mandatory Legal Compliance and Market Access

BIS CRS registration provides the legal authority to manufacture, import, and sell notified electronic medical products in India. Products covered under CRS cannot be marketed without a valid registration number. Compliance helps avoid penalties, product seizure, customs detention, and regulatory action by Indian authorities.

2. Enhanced Safety and Quality Assurance

Medical products registered under BIS CRS are tested in BIS-recognized laboratories for electrical safety, performance, and reliability. Compliance with Indian Standards reduces the risk of electrical hazards, malfunction, and inconsistent performance, ensuring patient safety and reliable clinical outcomes.

3. Increased Trust Among Healthcare Professionals

Doctors, hospitals, diagnostic labs, and procurement teams prefer CRS-registered medical products due to assured compliance with Indian safety norms. The BIS Standard Mark serves as proof of authenticity, helping eliminate low-quality or non-compliant electronic medical equipment from healthcare environments.

4. Competitive Advantage in Tenders and Procurement

Many government tenders, public healthcare institutions, and large private hospitals mandate BIS CRS registration as an eligibility requirement. Certified products gain priority in institutional procurement, organized retail channels, and e-commerce platforms that restrict listings to compliant electronic medical devices.

5. Reduced Legal and Business Risk

CRS registration helps manufacturers and importers minimize legal, financial, and reputational risks. Adherence to BIS standards lowers the chances of product failure, recalls, and liability claims. In case of inspections or investigations, a valid CRS registration demonstrates due diligence and regulatory compliance.

Documents Required for BIS ISI Certification for Medical Products

For obtaining BIS ISI Certification (Scheme I) for medical products, manufacturers must submit basic business, product, and factory-related documents. These documents help BIS verify the company’s legal status, production capability, and product quality.

1. Business & Company Documents

Company registration proof (Incorporation / Partnership).
Factory address proof (Factory License / Rent Agreement).
GST registration and PAN card.
MSME / Udyam certificate (if available).
Trademark certificate, if applicable.

2. Product Details

Product description with model, size, or type.
Product drawings or design layout (if required).
List of raw materials and components.
Manufacturing process flow chart.

3. Factory & Quality Control Details

List of manufacturing machinery.
List of in-house testing equipment.
Calibration certificates from NABL labs.
Details of quality control staff.
Factory layout plan.

4. Application & Authorization Documents

Online BIS application (Form V).
Authorization letter, if applicable.
AIR details for foreign manufacturers.
Product test reports from BIS-recognized lab.

Process to get BIS ISI Mark Certification on Medical Products

The BIS ISI Mark certification process for medical products follows a structured procedure that includes application filing, factory inspection, and product testing. For domestic manufacturers, the entire process generally takes 60 to 90 days, depending on inspection schedules and laboratory test results.

Selection of Applicable Indian Standard: Identify the correct IS Code relevant to the medical product, such as IS 3055 for clinical thermometers or IS 7620 for diagnostic X-ray equipment.
Online Application Submission: File the application through the BIS Manak Online portal along with required documents, product details, and factory layout.
Appointment of Quality Control Personnel: Nominate a qualified technical person responsible for in-house testing and quality monitoring.
Factory Inspection by BIS: A BIS officer visits the manufacturing unit to verify production processes, machinery, testing facilities, and quality control systems.
Sample Drawing and Testing: Product samples are sealed during inspection. One set is tested in-house and another is sent to a BIS-recognized laboratory for independent testing.
Grant of ISI License: If test results conform to the applicable IS and the inspection is satisfactory, BIS grants the Certification Marks License (CM/L).

MEDICAL PRODUCTS UNDER BIS CRS CERTIFICATION SERVICE

Product	Standard	Product	Standard
Disposable baby diapers	IS 17509: 2021	Disposable adult diapers	IS 17508: 2020
Sanitary napkins	IS 5405: 2019	Reusable sanitary napkins	IS 17514: 2021
Disposable underpads (bed protectors)	IS 17379: 2020	Feminine hygiene pants	IS 17509 (Part 2): 2021