Medical & Products Registration
Expert Regulatory Guidance from Classification
to Compliance
We are your strategic partner for Regulatory Affairs and Quality Assurance in the Medical Device and Cosmetics sectors. We navigate the complexities, so you can focus on growth.
What We Offer
Dedicated to Your Wellbeing
Regulatory & Compliance
Comprehensive solutions for NMRA registration and compliance:
- Medical Devices Registration
- Cosmetics Registration
- Borderline Products Compliance
- Import License Management
Health Check
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Doctor Receipt
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Pharmacy Store
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What We Offer
Certifications We Help You Achieve
ISO QMS
ISO 9001, ISO 13485 and other quality management system certifications
GMP
Good Manufacturing Practice compliance for various industries
EMS
Environmental Management System ISO 14001 certification
EMS
Environmental Management System ISO 14001 certification
OH&S
Occupational Health & Safety ISO 45001 certification
Become a Mamber
We Guarantee Customer Satisfaction Through Professional Care
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Contact Us
(+54) 76433986
mail@medease.id
Our Blog
Blog & Articles
Cosmetics vs. Medical Device vs. Borderline: How to Classify Your Product Correctly in Sri Lanka
A rejected dossier can lead to significant delays and costs. We outline…
5 Common Mistakes in Dossier Submission and How to Avoid Them
A rejected dossier can lead to significant delays and costs. We outline…
Navigating the NMRA Reliance Pathway: A Guide for Medical Device Importers
The NMRA’s new reliance pathway, effective October 2025, represents a significant opportunity…
About Us
Dedicated to Your Wellbeing
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Our Vision
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Our Mission
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#Experienced
25+
Experienced
Pharmacy & Medical
Experience Hassle-free Compliance
with RAQ
At Healin’ Pvt Ltd, we’re more than just a consultancy; we’re your strategic partner in navigating the complex world of medical device and cosmetic product regulations. Our dedicated team of experts specializes in offering comprehensive solutions tailored to your unique needs, ensuring your products not only comply with the National Medicines Regulatory Authority (NMRA) standards but also thrive in the competitive market.
Open Hours
Mon-Fri : 06am-23pm
100%
Happy Client
Comprehensive Services
Excellence in Pharmacy and Medical Care
Regulatory Affairs
- NMRA Product Registration
- Manufacturing Site Registration
- Import License Management
- Legal Representation
- Labeling & Translation Services
Quality Assurance
- ISO 9001 Certification
- GMP Implementation
- SLS Mark Certification
- Cosmetic Formulation
- Post-Market Surveillance
Become a Mamber
We Guarantee Customer Satisfaction Through Professional Care
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam.
Contact Us
(+54) 76433986
mail@medease.id
The Expertise Behind RAQ
The strength of RAQ lies in our expert team. Comprised of industry veterans and specialists in regulatory affairs, quality assurance, and product compliance, our team brings together a rich tapestry of knowledge and experience. Each member is not just an expert in their domain but is also passionately committed to our vision of making regulatory compliance accessible and manageable for businesses of all sizes.
Our FAQs
Why Partner with RAQ for Borderline Products?
At RAQ by Healin’ Pvt Ltd, we understand the intricacies of borderline product registration.
Expertise in Classification
The success of a borderline product registration hinges on the initial classification. Our deep understanding of the NMRA's evaluation criteria gives your product the best chance of being classified correctly from the start.
Strategic & Meticulous
We understand the nuances between schedules and the specific documentation required for each. Our attention to detail prevents common errors that can lead to delays or incorrect classification.
A Clear Path Forward
The ambiguity of borderline products can be a significant business challenge. We provide a clear, strategic path through the regulatory process, allowing you to plan your market entry with confidence.
Complete Registration Management
Expert management of the entire registration process, ensuring your product complies with Sri Lankan regulations from submission to approval.
Our Services
Your End-to-End Compliance Partner
From initial strategy to final approval, we offer a comprehensive suite of services tailored to your specific needs.
Product Registration
We manage the entire NMRA registration lifecycle for Medical Devices, Cosmetics, and Borderline Products. Our meticulous approach ensures your dossier is accurate, complete, and submitted for timely review.
- Medical Devices Registration
- Cosmetics Registration
- Borderline Products Compliance
- Import License Management
Quality Management Systems
ISO 9001 certification services to enhance operational excellence:
- QMS Development
- Implementation Support
- Certification Guidance
- Audit Preparation
GMP Certification
Good Manufacturing Practice compliance across industries:
- Cosmetics GMP
- Medical Devices GMP
- Food Safety Standards
- Facility Audits
What We Offer
Have a Project in Mind?
Let’s turn your regulatory challenges into market opportunities. Schedule a free,
no-obligation consultation with our experts today.
Our Approach
Excellence in Pharmacy and Medical Care
At Healin’ Pvt Ltd, we blend our deep regulatory knowledge with a customer-centric approach. Our solutions are not just about meeting standards; they’re about adding value to your business and products. We understand the intricacies of the industry and provide personalized support every step of the way.
Cost & Time Effective
We provide the most cost and time-effective consultancy services. We always challenge ourselves to offer the best value for money consulting services proposal.
Minimum Documentation
We develop minimum documentation first and then expand if our clients wish to raise the bar beyond this minimum level. We believe that the developed system should make your life easier.
Simple Solutions
Our professional consultants help organizations implement management systems that are simple with no unnecessary complications or documentation.
Comprehensive Services
Excellence in Pharmacy and Medical Care
Quality Assurance
- ISO 9001 Certification
- GMP Implementation
- SLS Mark Certification
- Cosmetic Formulation
- Post-Market Surveillance
Quality Assurance
- ISO 9001 Certification
- GMP Implementation
- SLS Mark Certification
- Cosmetic Formulation
- Post-Market Surveillance
Testimonials
Member Feedback & Reviews
Our Commitment
Fostering a Culture of Quality
At RAQ, we believe that a strong regulatory framework is the cornerstone of a safe and thriving market. We are proud to work within the system established by the NMRA and other international bodies like ISO to help our clients not only meet but exceed the required standards.
Our role is to facilitate this process, ensuring that every product we help register and every quality system we help implement contributes positively to the industry and to the health and well-being of consumers. We are committed to being a constructive force for quality and safety in Sri Lanka.
What We Offer
Certifications We Help You Achieve
ISO QMS
ISO 9001, ISO 13485 and other quality management system certifications
GMP
Good Manufacturing Practice compliance for various industries
EMS
Environmental Management System ISO 14001 certification
OH&S
Occupational Health & Safety ISO 45001 certification
Comprehensive Services
Why Our Clients Choose RAQ
Professional Excellence
- Highly qualified and experienced team
- Up-to-date knowledge of regulations
- Proven methodologies and processes
- Attention to detail and accuracy
Client Success Focus
- Faster time to market
- Cost-effective solutions
- Ongoing support and guidance
- High success rate in approvals
Who We Serve
Is This Service for You?
Our Marketing Authorization Holder (MAH) service is specifically designed for:
International manufacturers of medical devices or cosmetics.
Companies that do not have a registered legal entity or physical office in Sri Lanka.
Businesses looking for a professional, reliable, and independent local partner to manage their regulatory responsibilities.
What is ISO 9001
The Global Standard for Quality Management
ISO 9001 is the world’s most recognized standard for Quality Management Systems (QMS). It is not a product standard, but a framework that provides a set of principles to ensure a common-sense approach to the management of your business activities to consistently achieve customer satisfaction.
At its core, ISO 9001 is built on a process-based approach and the “Plan-Do-Check-Act” (PDCA) cycle. It provides a robust framework for monitoring and improving performance in any area you choose, helping organizations of all sizes and industries to:
- Consistently meet customer requirements.
- Enhance customer satisfaction.
- Improve operational efficiency and reduce waste.
- Implement a culture of continual improvement.
What is a Borderline Products?
Intended Use
The product’s primary function and its mode of action.
Therapeutic Claims
Any claims made by the manufacturer about treating or preventing disease.
Active Substances
The presence and concentration of any pharmacologically active ingredients.
Efficacy and Ingredients
The proven effectiveness and the specific formulation of the product.