MD-15 License Approval for MH Scientifics: Streamlining Medical Device Manufacturing Compliance in Andhra Pradesh
A detailed regulatory success story for a MH Scientifics.
The Challenge
MH Scientifics, a medical device manufacturing unit based in Chittoor, Andhra Pradesh, led by Dr. Nagendra, needed to obtain an MD-15 manufacturing license under the Medical Device Rules, 2017 to legally manufacture and market their devices. The unit faced challenges navigating CDSCO/State Licensing Authority documentation requirements, quality management system (QMS) readiness, site master file preparation, and device risk classification — all critical prerequisites before a license could be granted.
Our Solution
MedRegX India conducted a complete regulatory gap assessment of MH Scientifics' manufacturing facility, classified the devices under the applicable risk class, and prepared the full MD-15 application dossier — including the Plant Master File, Device Master File, QMS documentation aligned with ISO 13485, and labelling compliance review. Our team coordinated directly with the State Licensing Authority, managed pre-approval facility inspection readiness, and resolved queries raised during the review cycle
Final Result
MH Scientifics successfully secured its MD-15 manufacturing license, enabling legal commercial manufacturing and market entry for its medical devices. The streamlined documentation and inspection-readiness process reduced back-and-forth queries and helped the client avoid delays common in first-time license applications.
Detailed Implementation
The Challenge
MH Scientifics, a medical device manufacturing unit based in Chittoor, Andhra Pradesh, led by Dr. Nagendra, needed to obtain an MD-15 manufacturing license under the Medical Device Rules, 2017 to legally manufacture and market their devices. The unit faced challenges navigating CDSCO/State Licensing Authority documentation requirements, quality management system (QMS) readiness, site master file preparation, and device risk classification — all critical prerequisites before a license could be granted.
The Solution
MedRegX India conducted a complete regulatory gap assessment of MH Scientifics' manufacturing facility, classified the devices under the applicable risk class, and prepared the full MD-15 application dossier — including the Plant Master File, Device Master File, QMS documentation aligned with ISO 13485, and labelling compliance review. Our team coordinated directly with the State Licensing Authority, managed pre-approval facility inspection readiness, and resolved queries raised during the review cycle.
The Result
MH Scientifics successfully secured its MD-15 manufacturing license, enabling legal commercial manufacturing and market entry for its medical devices. The streamlined documentation and inspection-readiness process reduced back-and-forth queries and helped the client avoid delays common in first-time license applications.