BIS Licence and ISI Mark Certification for Medical Products

A BIS licence lets a manufacturer apply the ISI mark to a product that conforms to the relevant Indian Standard. For medical and hospital products it can be mandatory under a Quality Control Order, expected by public buyers, or simply a mark of assurance. Medfins International maps your product to the right standard, plans testing and prepares your factory for the BIS audit.

What is a BIS licence and the ISI mark?

The Bureau of Indian Standards (BIS) operates product certification under the Bureau of Indian Standards Act, 2016 and the BIS (Conformity Assessment) Regulations. Under the product certification scheme, BIS grants a licence to a manufacturer for a specific product, standard and factory. The licence holder may then apply the ISI mark with its licence number to products that meet the Indian Standard.

A BIS licence is always tied to one manufacturing location. Traders and importers cannot hold a BIS product licence in their own name; the licence belongs to the factory that makes the product.

How BIS relates to medical device regulation

In India, medical devices and IVDs are regulated by CDSCO under the Medical Devices Rules, 2017. BIS certification does not replace a CDSCO manufacturing licence or import licence. The two interact in several ways:

• The Medical Devices Rules expect devices to conform to standards laid down by BIS where they exist, with international standards applying otherwise.
• BIS publishes Indian Standards for many medical, surgical and hospital products, some harmonised with ISO and IEC standards.
• Quality Control Orders issued by government ministries can make BIS certification mandatory for particular products, including some medical-adjacent items.
• Public procurement specifications often call for ISI-marked products or conformity to a named Indian Standard.

Who needs a BIS licence?

• Manufacturers of products covered by a Quality Control Order, for whom certification is compulsory before sale or import.
• Makers of hospital equipment, consumables and related products who supply government and institutional buyers.
• Overseas manufacturers exporting products to India that require the ISI mark, through the Foreign Manufacturers Certification Scheme.
• Manufacturers seeking a recognised Indian quality mark for market positioning, where certification is voluntary.

Because Quality Control Orders are issued, amended, deferred and withdrawn from time to time, we always check the current status for your exact product before advising whether certification is mandatory.

Overseas manufacturers

Foreign factories apply under the Foreign Manufacturers Certification Scheme. The process follows the same principles as for Indian factories, with testing and a factory audit, but the audit takes place at the overseas site and the manufacturer must nominate an Authorised Indian Representative. Planning travel, samples and document translation early helps avoid long gaps between steps. This role can be coordinated with the manufacturer’s Indian authorised agent for CDSCO so that details stay consistent.

Documents required

• Application with details of the manufacturer, factory, product and applicable Indian Standard.
• Factory registration, ownership or lease documents and site layout.
• Manufacturing process flow chart and list of machinery.
• List of in-house testing equipment with calibration records, as required by the standard’s scheme of testing and inspection.
• Details of the quality control in-charge and testing personnel.
• Test report from a BIS-recognised laboratory, where the chosen procedure requires it.
• For overseas factories: nomination of an Authorised Indian Representative and related undertakings.

Step-by-step process

1. Standard mapping: identify the correct Indian Standard, its latest version and any product variants.
2. Gap assessment of the product, in-house testing facilities and quality control against the standard.
3. Online application on the BIS portal with the fee and supporting documents.
4. Product testing at a BIS-recognised laboratory, either before application or on samples drawn during the audit, depending on the procedure followed.
5. Factory audit by a BIS officer to verify production, testing capability and quality control.
6. Grant of licence and permission to use the ISI mark with the licence number.
7. Ongoing compliance: surveillance audits, market sampling, marking fees and renewal.

Timelines and what affects them

The time to a BIS licence depends on the procedure used, laboratory availability for the relevant standard, the readiness of in-house testing equipment and, for overseas factories, scheduling of the BIS audit abroad. Products with complex tests or few recognised laboratories generally take longer. Preparing the factory before applying usually reduces the number of observations at audit.

Common reasons for queries and delays

• Applying against the wrong or an outdated version of the Indian Standard.
• In-house test equipment missing or not calibrated as required by the scheme of testing.
• Test reports that do not cover all requirements or variants in the application.
• Differences between the brand, model or factory details in the application and those on site.
• For foreign manufacturers, incomplete documents from the Authorised Indian Representative.

BIS licence and government procurement

An ISI-marked product can be a strong advantage in public tenders. On the Government e-Marketplace, OEMs holding a valid BIS licence may be eligible for exemption from vendor assessment for the relevant products, which can shorten onboarding. See our GeM registration and vendor assessment service for details.

How Medfins International supports you

Medfins International combines medical device regulatory knowledge with quality system audit experience. Our managing director is a CQI and IRCA certified ISO 13485 Lead Auditor, so we prepare factories for audit with the same discipline used for quality certification. We can:

• Check whether BIS certification is mandatory for your product today.
• Map products to the correct Indian Standard and plan testing.
• Prepare documents and file the application.
• Conduct a mock audit of production and in-house testing.
• Support surveillance, renewals and scope extensions.

To discuss your product and standard, contact our team.

Frequently asked questions