Medical Device GMP
Achieving NMRA GMP for Cosmetics GMP
End-to-end consulting for local manufacturers to successfully pass NMRA Good Manufacturing Practice (GMP) inspections and secure your license to operate.
Foundation of Medical Device Quality
A Non-Negotiable Requirement for Local Manufacturers
For any local manufacturer of medical devices in Sri Lanka, securing site approval from the National Medicines Regulatory Authority (NMRA) is a mandatory first step. This approval is granted only after a facility has proven it complies with Good Manufacturing Practices (GMP).
Unlike cosmetics, the NMRA conducts its own rigorous GMP inspections for medical device manufacturing sites. Passing this inspection is not just a regulatory hurdle; it is a fundamental requirement to ensure that the devices you produce are safe, effective, and meet the highest standards of quality. Without NMRA GMP approval, you cannot legally manufacture or sell your medical devices in Sri Lanka. At RAQ, we specialize in preparing local manufacturers for a successful NMRA GMP inspection.
The Path to NMRA GMP Approval
Understanding the NMRA Inspection and Approval Process
The NMRA’s approval process is a structured journey designed to verify every aspect of your quality system. We guide you through each critical stage.
Application & Site Master File (SMF) Submission
The process begins with a formal application to the NMRA. A critical component of this is the Site Master File—a detailed document describing your facility, personnel, quality management system, and all production activities.
NMRA GMP Inspection / Audit
Once the application is reviewed, the NMRA will schedule a physical inspection of your manufacturing site. Their auditors will assess your facility’s compliance with GMP principles, covering everything from premises and equipment to documentation and quality control.
GMP Certificate & License to Manufacture
Upon successful completion of the audit and closure of any findings, the NMRA will issue a GMP certificate for your facility. This is the key that unlocks your license to manufacture medical devices in Sri Lanka.
Our End-to-End GMP Consulting Services
Your Strategic Partner for Inspection Readiness
Our goal is to ensure your facility is not just compliant, but inspection-ready at all times. We provide comprehensive, hands-on support based on the principles of ISO 13485, the global standard for medical device quality management systems.
Gap Analysis & Strategic Planning
We conduct a thorough audit of your existing systems against NMRA GMP requirements and ISO 13485 standards to identify all gaps and create a prioritized action plan.
Quality Management System (QMS) Development
We help you build and document a robust QMS aligned with ISO 13485, covering everything from design controls and risk management to supplier management and traceability.
Site Master File (SMF) Preparation
We work with your team to prepare a comprehensive and professional Site Master File that accurately reflects your operations and meets all NMRA guidelines.
Pre-Audit & Inspection Readiness
We conduct mock NMRA inspections and internal audits to prepare your facility and staff for the real audit. We help you address potential issues proactively, ensuring you face the official inspection with confidence.
The RAQ Advantage
Why Choose RAQ for Your Medical Device GMP?
Deep Regulatory Expertise
We understand the specific focus of NMRA auditors. Our consulting is tailored to meet local regulatory expectations while building a quality system that adheres to global standards like ISO 13485.
A Focus on Patient Safety
We believe that good manufacturing practices are fundamentally about protecting patients. We help you build a culture of quality that goes beyond the certificate, ensuring your products are consistently safe and reliable.
A Partner for the Long Term
GMP is not a one-time event. We help you build a sustainable quality system that is easy to maintain, ensuring you remain compliant through routine surveillance audits and continuous improvement.
Call to Action
Build a World-Class Facility. Secure Your Place in the Market.
Ensure your manufacturing site meets the NMRA’s standard of excellence. Contact us today to prepare for your GMP inspection.