Republic of India Compliance
Republic of India Regulatory & Compliance Statement
Public regulatory and compliance statement for Republic of India DPDP, CDSCO/medical-device, telemedicine, healthcare advertising, ISO/BIS readiness, securities, and institutional pilot considerations.
Last updated: 27 June 2026
DPDP Data Fiduciary Position
For India data principals submitting personal data through the website, Provenant AI Labs Pte. Ltd. acts as the data fiduciary unless a separate written agreement states otherwise. Personal data is processed for notified purposes such as responding to enquiries, evaluating pilot discussions, managing commercial communications, security, compliance, and recordkeeping. India-facing practices should be reviewed against the Digital Personal Data Protection Act, 2023 and applicable Digital Personal Data Protection Rules as they come into force.
CDSCO Medical-Device Position
Public product and case-study pages are not advertisements for diagnosis, cure, mitigation, treatment, monitoring, or prevention of disease in India. Provenant products are not represented as CDSCO-registered or approved medical devices, diagnostic systems, treatment systems, monitoring systems, or patient management systems in India. Any India deployment requires classification, licensing, registration, clinical, cybersecurity, procurement, and institutional review under applicable law, including the Medical Devices Rules, 2017 where relevant.
Telemedicine Position
Provenant AI Labs does not provide medical consultation or telemedicine services to patients. Any India telemedicine service must be provided by appropriately qualified Registered Medical Practitioners and healthcare institutions under applicable National Medical Commission, Ministry of Health and Family Welfare, state medical council, and institutional requirements.
ISO Standards Roadmap
Provenant AI Labs plans to maintain an ISO-aligned readiness roadmap for information security, privacy, quality management, telehealth service planning, laboratory-facing workflows, and regulated product development. Candidate frameworks may include ISO/IEC 27001 for information security management, ISO/IEC 27701 for privacy information management, ISO 9001 for quality management, ISO 13131 for telehealth services quality planning, ISO 13485 if a product is formally taken forward as a medical-device design, manufacture, service, or delivery system, ISO 15189 and ISO 15190 for medical laboratory quality/competence and safety considerations, and ISO/IEC 17025 where testing or calibration laboratory competence is in scope. No ISO certification, accreditation, or conformity assessment is claimed unless expressly published by Provenant AI Labs with the applicable scope, certificate body, certificate number, and validity period.
BIS / ISI Mark Roadmap For India
For India market entry, Provenant AI Labs will assess whether any hardware appliance, peripheral, electrical/electronic component, medical device, or packaged product falls within a Bureau of Indian Standards compulsory certification scheme, Quality Control Order, Scheme I ISI Mark requirement, Scheme II registration requirement, or other applicable conformity assessment route. ISI/BIS marking will not be used, displayed, or implied unless the relevant product, Indian Standard, licence, marking permission, and scope have been confirmed by BIS or another competent authority.
Investor And Securities Notice
This website is not a public offer, private placement invitation, prospectus, placement memorandum, or solicitation under the Companies Act, SEBI regulations, or other Indian securities laws. Any India investor discussion is subject to prior legal review and applicable eligibility requirements.
Reference Frameworks
- MeitY - Digital Personal Data Protection Act, 2023
- MeitY - Digital Personal Data Protection Rules, 2025
- CDSCO - Medical devices and diagnostics
- CDSCO - Medical Devices Rules, 2017
- NMC/MoHFW - Telemedicine Practice Guidelines
- SEBI - Regulatory resources
- ISO/IEC 27001 - Information security management systems
- ISO 13131 - Telehealth services quality planning guidelines
- ISO 13485 - Medical devices quality management systems
- ISO 15189 - Medical laboratories quality and competence
- ISO 15190 - Medical laboratories safety
- ISO/IEC 17025 - Testing and calibration laboratories
- BIS - Products under compulsory certification
- BIS - Scheme I ISI Mark Scheme
This country regulatory and compliance statement is for general information only. It is not legal, medical, regulatory, investment, procurement, or clinical advice and does not replace formal review by qualified counsel, clinicians, regulators, or institutional stakeholders.