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 product certification scheme governed by the Bureau of Indian Standards (BIS) under Scheme-I of the BIS Conformity Assessment Regulations. It ensures that medical products conform to the applicable Indian Standards (IS) specified under notified Quality Control Orders (QCOs).

Under the ISI Mark scheme, manufacturers are required to demonstrate compliance through product testing, implementation of an effective quality control system, and successful factory inspection conducted by BIS officials. Only after meeting these requirements is a Certification Marks License (CM/L) granted, allowing the use of the ISI Mark on the product.

BIS ISI certification applies to a wide range of medical products such as surgical gloves, face masks, sanitary products, disposable medical items, and other notified healthcare products. The certification is mandatory for both Indian and foreign manufacturers supplying medical products to the Indian market and helps ensure patient safety, regulatory compliance, and consistent product quality.

Benefits of BIS ISI Certification for Medical Products

BIS ISI Certification is a mandatory quality conformity scheme for notified medical products in India. It ensures that medical devices conform to applicable Indian Standards for safety, performance, and reliability. Apart from statutory compliance, ISI certification offers significant commercial, operational, and credibility benefits for manufacturers.

1. Mandatory Regulatory Compliance

BIS ISI Certification is legally required for specified medical products before manufacturing or sale in India. Non-certified products are subject to penalties, seizure, and regulatory action by authorities.

2. Assured Quality and Patient Safety

ISI-certified medical products undergo rigorous testing as per Indian Standards to ensure quality, safety, and consistent performance, reducing risks of malfunction and clinical hazards.

3. Increased Trust and Market Acceptance

Hospitals, healthcare institutions, and procurement agencies prefer ISI-certified products due to assured compliance with national quality standards, improving brand credibility.

4. Eligibility for Government Tenders

BIS ISI Certification is mandatory for participation in most government tenders, PSU procurements, and public healthcare projects, enabling access to large institutional buyers.

5. Reduced Legal and Business Risk

Compliance with ISI standards minimizes risks related to product recalls, legal liability, and reputational damage, ensuring long-term business sustainability.

Documents Required for BIS ISI Certification for Medical Products

To obtain BIS ISI Certification under Scheme I, manufacturers must submit documents related to business registration, product details, manufacturing infrastructure, and quality control systems.

1. Business & Company Documents

Certificate of Incorporation / Partnership Deed
Factory address proof (License / Lease Agreement)
GST registration and PAN card
MSME / Udyam registration (if applicable)
Trademark certificate (if applicable)

2. Product Details

Product description with model and variants
Technical drawings or specifications
List of raw materials and components
Manufacturing process flow chart

3. Factory & Quality Control Details

Manufacturing machinery list
In-house testing equipment details
Calibration certificates from NABL labs
Quality control staff details
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 labs

Process to Get BIS ISI Mark Certification on Medical Products

The BIS ISI Mark certification process includes application submission, factory inspection, and product testing. The process generally takes 60 to 90 days for domestic manufacturers.

Selection of Applicable Indian Standard: Identify the correct IS Code applicable to the medical product.
Online Application Submission: Apply through the BIS Manak Online Portal with required documents.
Nomination of Quality Control Personnel: Appoint a qualified technical person for quality monitoring.
Factory Inspection by BIS: BIS officials inspect the manufacturing unit and testing facilities.
Sample Testing: Samples are tested in BIS-recognized laboratories for conformity.
Grant of ISI License: Upon compliance, BIS issues the ISI Certification Marks License (CM/L).

MEDICAL PRODUCTS UNDER BIS ISI CERTIFICATION SERVICE

Product	Standard	Product	Standard
Disposable baby diapers	IS 17509: 2021	Disposable adult diapers	IS 17508: 2020
Sanitary napkins	IS 5405: 2019	Surgical Face Masks	IS 16289: 2014
Respiratory Protective Devices – Filtering Half Masks	IS 9473: 2002	Disposable Surgical Rubber Gloves	IS 13422: 1992
Medical Textile Bedsheets and Pillow Covers	IS 17630: 2021		-