Official Regulatory Partner for Medical Device Compliance

TQMS Certifications Pvt. Ltd. is proud to be designated as an official Notified Body by the Central Drugs Standard Control Organization (CDSCO), New Delhi. Under the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Device Rules (MDR) 2017, TQMS is authorized to conduct audits, assessments, and verifications for Class A and Class B medical devices.

What is a Notified Body?

In the landscape of Indian medical regulation:

• “Notified” refers to being officially recognized in the Gazette by the Central Government.
• “Notified Body” is a registered legal entity (under Rule 13) deemed competent to audit manufacturing sites and verify that medical devices meet stringent quality and safety standards.

Note: Per the Drugs Controller General of India (DCGI), only registered Notified Bodies are authorized to audit medical device manufacturing sites. No other third-party individuals or unauthorized institutions are permitted to perform these regulatory audits.

Understanding Medical Device Classification

The Medical Device Rules 2017 categorize products based on their risk profile. This classification determines the level of regulatory oversight required.

Our Scope of Services

As your CDSCO-registered partner, TQMS facilitates the transition from manufacturing to market-readiness by ensuring total compliance with the Quality Management System (QMS) and essential principles of safety.

1. Mandatory Audits

   We conduct comprehensive on-site audits for Class A and Class B domestic manufacturing sites to verify conformity with the Fifth Schedule of MDR 2017.

2. Technical Assessments

   We perform in-depth reviews of technical documentation and design dossiers to ensure your product’s quality, safety, and performance align with national standards.

3. Support for Class C & D

   On a case-by-case basis, TQMS may be called upon by the Central Government to assist in the verification and assessment of higher-risk (Class C and D) devices.

The TQMS Audit Procedure

• Document Review: Technical review of documents as prescribed in the Fourth Schedule.
• On-Site Examination: Verification of the manufacturer’s (and sub-contractor’s) QMS against Fifth Schedule requirements.
• Design Conformity: Evaluation of design documents to ensure performance benchmarks are met.
• Non-Compliance Management: If gaps are identified, we provide a clear report. For major non-compliances, we allow a reasonable window for rectification followed by a verification visit.
• Final Reporting: Upon successful assessment, a detailed report including findings and recommendations is submitted to the State Licensing Authority, with a copy provided to the manufacturer.

Integrity & Conflict of Interest

TQMS operates under strict Standard Operating Procedures (SOPs) to identify and resolve any potential conflicts of interest, ensuring that every audit is conducted with the highest level of impartiality and ethical standards.

Are you ready to certify your medical device for the Indian market?