manufacturing

MD-05 License for Class A & B Devices

The Form MD-05 manufacturing license is a mandatory legal requirement for domestic manufacturing of low-risk (Class A) and low-moderate risk (Class B) medical devices under the Indian Medical Device Rules (MDR) 2017. Our regulatory consultancy provides end-to-end handholding through cleanroom facility design layouts, QMS (Quality Management System) documentation, SUGAM portal uploads, and representation during State Licensing Authority (SLA) audits to ensure quick approval with zero queries.

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Key Benefits

100% compliance with CDSCO Medical Device Rules (MDR) 2017 guidelines
Complete inspection readiness with mock audits and expert checklist reviews
Accurately compiled technical dossiers to prevent regulatory delay or queries

Recognized Standards

Our Methodology

Document Collection

Collection of documents from the client for creation of the CDSCO account.

CDSCO Account Setup

Creation and activation of the CDSCO online account.

NSWS Document Prep

Collection of documents from the client for creation of the National Single Window System (NSWS) account.

NSWS Account Setup

Creation and activation of the NSWS account.

Test License Review

Collection and review of documents required for the Test License application.

Test License Submission

Submission of the Test License application through the NSWS portal.

Gap Assessment

Gap Assessment of the manufacturing facility against applicable Medical Device Rules and regulatory requirements.

Technical Documentation

Preparation of technical documentation as per Schedule IV, including Device Master File (DMF) and Site Master File (SMF).

QMS Prep

Preparation of Schedule V requirements and Quality Management System (QMS) documentation.

QMS Implementation

Implementation of Schedule V requirements and Quality Management System (QMS) compliance at the manufacturing site.

CDSCO Submission

Submission of application through the CDSCO portal.

Notified Body Allocation

Allocation of a Notified Body by the licensing authority.

Notified Body Audit

Conduct of Notified Body audit and issuance of non-conformities (NCs), if any.

CAPA & NC Closure

Closure of NCs and submission of Corrective and Preventive Action (CAPA) evidence.

Audit Report Submission

Submission of the Notified Body audit report to the State Licensing Authority.

Application Review

Review and scrutiny of the application by the State Licensing Authority and closure of regulatory observations/comments, if any.

License Granted

Grant of Manufacturing License in Form MD-05 by the State Licensing Authority.

Required Documents

Site Master File (SMF)

Device Master File (DMF)

ISO 13485 QMS Certificate

Plant layout blueprint approved by qualified architect

Common Questions

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