India Medical Device Rules 2017: Draft Amendments (G.S.R. 515(E)) June 2026

This document is a sample notification published by the Ministry of Health and Family Welfare, Government of India, under G.S.R. 515(E), on 23rd June 2026. The amendments made relate to certain sections of the already existent Medical Devices Rules, 2017. The manufacturers from USA, Europe, and other foreign countries will have to adapt themselves to this new regulatory processing time and management process for registering their medical devices with the State Licensing Authority.

Quality Management System (QMS) Requirements and Site Conformance

Each and every manufacturing facility applying for registration must fully comply with the very demanding local provisions laid down in the Quality Management System (QMS), as per the Fifth Schedule of the Medical Devices Rules. Prior to issuance of any license for manufacture and marketing, such compliance has to be verified through an inspection conducted by a Notified Body, as per Rule 13.

Specific Regulatory Timelines 

This draft has incorporated timelines that need to be taken into consideration when making the plans by the external and internal entities. According to Rule 20, sub rule (5), the State Licensing Authority is supposed to conduct a detailed technical evaluation of the applications related to Class B medical devices and allocate them to the registered notified bodies strictly within thirty (30) days of the date of the online application. The critical aspect of the clock stopping process is the introduction of an additional factor where if the State Licensing Authority finds any deficiencies within the said period of thirty days, the clock is stopped, and it starts or "reckons" again from the date when the deficiencies are removed.

Notified Body Site Audits and Post Audit Reporting Windows

Upon successful registration of an application with a Notified Body, the State Licensing Authority is mandated to ensure that the actual audit of the manufacturing site is carried out in the exact manner stipulated in the Third Schedule within thirty (30) days after the registration of the application. After carrying out the audit, the Notified Body should, in accordance with the law, provide its final report along with recommendations to the State Licensing Authority within fifteen (15) days after the audit process is over. Where there is non conformance to the QMS requirement at the time of audit, a process of strict verification of compliance is set in motion, which needs to be carried out within twenty (20) days after submission of the manufacturer’s compliance report.

Inspection Framework and Licensing Windows

As far as the processes covered by the Rule 23 are concerned, there may be an inspection conducted on site by an authorized inspection team. With respect to Rule 23, sub rule (1), the standard period of processing has been modified, whereby the number sixty has been changed to fifty five days. Should the inspection team find any nonconformity regarding the QMS requirements during the process, then the compliance verification should be done explicitly within fifteen (15) days starting from the day when the manufacturer has submitted its compliance report to the relevant authority. Lastly, the overall period of time taken for the decision for licensing under Rule 21, sub rule (4) is shortened from forty five days to thirty days.

Costs and Application Documentation Requirements

Specific instructions with regard to the means of submissions, which states that the application will be processed using an online submission facility and that all documentation for compliance purposes is to be prepared based on the Third Schedule (Audit Protocol) and Fifth Schedule (QMS requirements). There is no specific monetary amount or fee associated with the process, nor is there a checklist that lists the specific documents to be used to prepare the initial application. All time lines depend specifically on the date of online submission and manufacturer reports thereafter.