BIS Certification for Medical Devices

Bureau of Indian Standards compliance demands specific routes depending on device risk category and power supply specifications. We provide end-to-end technical execution for all official schemes.

Compulsory Registration Scheme

ISI Mark Certification

Foreign Manufacturers Scheme

Mandatory testing and self-declaration filing under CRS for electronic medical hardware, powered diagnostic instruments, and healthcare IT equipment.

Full product conformity and factory quality control evaluation under Scheme-I for clinical devices requiring standard ISI mark authorization.

Dedicated FMCS licensing representation for international medical technology brands exporting equipment directly to the Indian market.

Lab Testing Coordination

License Renewal Support

CDSCO & Customs Alignment

Sample clearance, customized test protocols, and priority processing management with NABL-accredited BIS recognized testing laboratories.

Timely BIS registration renewals, scope inclusion filings, model additions, and annual regulatory surveillance audit defense.

Synchronizing BIS certification with CDSCO device import licenses, packaging metrology rules, and customs port entry documentation.

Certification Lifecycle Steps

Standard Mapping

Lab Sample Testing

Portal Submission

License Grant

Identifying applicable Indian Standards (IS) and determining whether CRS or ISI scheme applies to your specific device models.

Coordinating sample shipping, safety tests, and electromagnetic compatibility evaluation inside recognized domestic testing facilities.

Compiling technical dossiers, test reports, and factory inspection records for official Manakonline portal submission.

Securing official BIS approval, authorization numbers, and customized labeling guidelines for medical device packaging.

Verify BIS Requirements Today

Avoid port customs delays and non-compliance penalties. Partner with Artexa's regulatory team for rapid Indian market entry.