Authorisation for the listed device and intended use
- A licensed Class B medical device
- The named manufacturer and premises
- The generic and brand names
- The intended-use and clinical-boundary wording
004 / 006
Evidence · Regulatory licences
A licensed Class B mental-health screening and referral-support application.
RELIEF PLUS is listed under CDSCO Form MD-5 as a Mental Health Screening and Support Application manufactured by Mental Health Innovations Private Limited.
The regulatory annexure explicitly states that the platform is non-diagnostic and does not replace clinical judgement.
Regulatory status
RELIEF PLUS is licensed as a Class B medical device for its stated intended use.
On 20 July 2026, the Maharashtra State Licensing Authority issued Form MD-5 to Mental Health Innovations Private Limited for the manufacture for sale or distribution of a Class B medical device.
The annexure identifies the generic device as a “Mental Health Screening and Support Application” and the brand as Relief Plus. The licence remains subject to the Medical Devices Rules, 2017 and its prescribed conditions.
CDSCOFORM
MD-5Class B
MD-5Class B
Manufacture for sale or distribution
Mental Health Screening and Support Application
- Licence holder
- Mental Health Innovations Private Limited
- Brand
- Relief Plus
- Class
- Class B medical device
- Date
- 20 July 2026
- Licence number
- MFG/MD/2026/000505
Authorised intended use
A non-diagnostic screening and referral-support platform
The licence describes RELIEF PLUS as designed for mental-health management of students aged 18 and above and adult users. It collects self-reported screening data, applies rule-based scoring to support early identification of distress and related indicators, and facilitates referral to qualified mental-health professionals.
Earlier authorisation
Form MD-13 supported test and evaluation activity before the MD-5 licence.
Form MD-13, dated 2 July 2026, authorised manufacture of one Class B Mental Health Screening and Support Application for clinical investigation, test or evaluation, examination, demonstration, or training.
It should be presented as an earlier evaluation-stage authorisation in the regulatory timeline—not as a second equivalent market licence.
What the licence establishes
Regulatory status must be described without overreach.
Every scientific, clinical, or commercial claim
- Independent proof of every performance statistic
- Autonomous diagnosis or treatment authority
- Validation of every future AI feature
- Approval of claims outside the licence annexure
Next