Regulatory Update Brings Flexibility for Medical Device Sterilisation Outsourcing
The Central Drugs Standard Control Organisation (CDSCO) has announced a significant regulatory relaxation for medical device manufacturers in India. As per the updated directive, manufacturers can now outsource the sterilisation of medical devices to third-party facilities without obtaining a loan licence, provided the facility holds a valid sterilisation licence issued by the regulatory authority.
Sterilisation of medical devices is a crucial process that ensures products are free from harmful microbial contamination before use in healthcare settings. Until now, manufacturers without in-house sterilisation setups were required to secure a loan licence when utilising another manufacturer’s premises for this activity.
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The new regulation simplifies this process, allowing outsourcing through a mutual third-party agreement without the need for a loan licence, streamlining operational workflows for medical device companies.
Operon Strategist’s Role in Regulatory Compliance
Operon Strategist is a regulatory consultancy firm specializing in providing end-to-end services to medical device manufacturers, and healthcare-related industries. Below is a comprehensive overview of the services offered by Operon Strategist:
Operon Strategist – Key Services
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- Regulatory Consulting
Medical device registration (CDSCO, SFDA, SAHPRA, etc.)
Establishment license approvals - Turnkey Project Support
Plant layout design (GMP, ISO-compliant)
Equipment selection and installation
Cleanroom setup and validation - Quality Management Systems
ISO 13485, ISO 9001 and GMP implementation
Internal audits - Technical Documentation
Device Master File (DMF), Risk Management File
Labeling and dossier preparation - International Certifications
CE Marking, UKCA, US FDA 510(k), SFDA, SAHPRA support - Training and Audit Support
Regulatory compliance training
Audit handling and post-market surveillance - Specialized Services
SaMD compliance
Sterilization and biocompatibility support
- Regulatory Consulting
