In the dynamic healthcare landscape of Sri Lanka, the demand for Medical Devices is on a steady rise.
The National Medicines Regulatory Authority (NMRA), functioning under the Ministry of Health (MoH),
is the key regulatory body overseeing this sector. For foreign companies, navigating the Sri Lankan
medical device registration landscape requires a Local Authorized Representative, a role that RAQ by
Healin' Pvt Ltd is adept at fulfilling.
Regulatory Authority: National Medicines Regulatory Authority (NMRA)
Regulation: NMRA Act, No. 5 of 2015
Regulatory Pathway: Registration + Import License
Authorized Representative: RAQ by Healin' Pvt Ltd as your Sri Lanka Local Authorized Representative
QMS Requirement: ISO 13485:2016
Assessment of Technical Data: Handled by the Medical Devices Regulatory (MDR) Division
License Validity: 5 Years
Labeling Requirements: As per Section 77 of NMRA Act, No. 5 of 2015
Submission Format: Paper
Language: English, Sinhala & Tamil
Sri Lanka Medical Device Classification
Referencing the NMRA’s draft guidelines as of 25-08-2019, Sri Lanka employs a risk-based classification
system for medical devices. RAQ by Healin' Pvt Ltd can guide you through this classification, ensuring
that your products are accurately categorized from Listed Devices (Lowest risk) to Class III (High risk), as
well as through the IVD Classification System ranging from Class A to D based on individual and public
health risks.
Medical Device Classification system
| Device Class | Risk Level | Examples |
|---|---|---|
| Listed Device | Lowest | Toothbrush, Feeding bottle, Bio safety cabinets etc. |
| Class I | Lowest | Reusable Surgical instrument, cotton wool etc. |
| Class IIa | Medium | Contact lenses, endoscopes, ultrasound scanners etc. |
| Class IIb | Moderate | Orthopaedic implants, dental implants, haemodialysis machines etc. |
| Class III | High | Cardiac pacemakers, angiography catheters, cranial shunts etc. |
IVD Classification System
| Class | Risk Level |
|---|---|
| A | Low Individual Risk and Low Public Health Risk |
| B | Moderate Individual Risk and/or Low Public Health Risk |
| C | High Individual Risk and/or Moderate Public Health Risk |
| D | High Individual Risk and High Public Health Risk |
Sri Lanka Medical Device Registration Process
- 1. Manufacturing Site Registration: Before any import or registration steps, it is mandatory to register the manufacturing site with the NMRA. This foundational step ensures that the manufacturing processes meet the regulatory standards set by the Sri Lankan authority.
- 2. Obtaining a Sample Import License: Following the manufacturing site registration, the next step involves obtaining a sample import license. This license allows for the importation of device samples for testing and evaluation, setting the stage for full registration.
- 3. Device Registration: Once the sample import license is obtained, the actual device registration process begins. This involves submitting the device along with all necessary documentation, sample labels, and Instructions for Use (IFU) in English, Sinhala, and Tamil to the NMRA for approval.
- 4. Import License: Following the NMRA's approval of the device registration, an import license for the commercial consignment of the devices is required. This final step permits the marketing and distribution of the medical devices in Sri Lanka.
Post Approval Device Life Cycle Management
Post-approval, RAQ by Healin' Pvt Ltd offers a range of services to ensure ongoing compliance and management of your medical devices. Our services include change management for existing approvals, maintenance and renewal of licenses, and continuous liaison with the NMRA. We also manage all aspects of importation, ensuring a smooth transition from regulatory approval to market presence.
RAQ Expertise
Our team at RAQ by Healin' Pvt Ltd is skilled in every aspect of the Sri Lankan medical device regulatory landscape:
- Regulatory Due-Diligence
- Manufacturing Site Registration
- Sample Importation and In-Country Testing
- Device Registration and Import License Acquisition
- Legal Representation and Labeling Support
- Translation Services
- Distributor Identification, Qualification, and Post-Marketing Surveillance
- Post Approval Change Management and License Renewal
With RAQ by Healin' Pvt Ltd, you can navigate the complexities of the Sri Lankan healthcare market with confidence, assured by our commitment to precision, compliance, and your success.
We provide the most cost and time-effective consultancy services. We always challenge ourselves to offer the best value-for-money consulting services proposal.
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.
our professional consultants help organisations implement management systems that are simple with no unnecessary complications or complications or documentation
Our expert consultants can help make real improvements to your management systems and your business. Our focus is on providing solutions that assist your business.
The Service that ISO Consulting has provided to our company has been outstanding. The level of always providing support is very comforting, they have always provided assistance when needed and gone above and beyond to assist in the process. Malik’s support and quick response is always comforting his willingness to always ensure my issues are dealt with and sorted with. ISO Consulting isn’t a company that just takes your money and leaves you to figure everything out for yourself. They are with you in every process of the way, Thank You ISO for your time and service.
Value for money with excellent services. Due diligent and easy to read for certification policy and form manuals. It is great to have the additional information for all the freebies like access to marketing, web etc. Personally like to thank Dr. Arash Niavarani for his professionalism and proactiveness. Very responsive. Keep it up, great services.
I found ISO through google search; my experience with ISO has always been positive. I had an audit last month for certification; I decided to add another registration group to my groups; I contacted ISO to request information I needed during lunch break; within 15 minutes; I had all information I needed and was able to add another registration group. Thank you so much ISO.
I am so grateful to have been referred to ISO by a friend of mine who recently used this service for their NDIS verification. I have been working with Arash throughout my NDIS verification process, I am just in the final leg of getting my audit done. I must say that Arash has been a real help to me. I had no idea where to begin and with Covid restrictions taking away face to face contact, being able to speak to someone whenever I had question made the whole process a little easier for me. Thank you to Arash and to the team at ISO, I am a very happy customer!
Originally stumbled across in early 2020 we at TriCollective are grateful to be able to come back to the same company to ensure consistency of documentation that meets the high standards we must maintain. Having quality NDIS specific documentation is invaluable and ISO Consulting have quickly become one of our most important external Teams when it comes to documentation support and compliance. Thanks so much ISO for making our lives so much easier!
We recently had a very good experience with the ISO team. Received the maximum support to fulfil all our requirements. I would really recommend ISO for their better customer service and great communication
Arash was very helpful before the audit and just around the audit time. The documents were up to scratch. Really appreciated. Keep up the good and professional work you are doing.
Highly recommend ISO Consulting Services. The documents and all help provided were simple to follow. Arash and Dawood were excellent and very responsive. Glad we chose ISO Consulting Services.
We are happy that we chose ISO consulting services for our application. Arash and Malik were very professional and helpful throughout the process. Will definitely recommend ISO for everyone who are struggling with their NDIS service provider application
Many thanks to Arash and the team for their amazing work. Your resources are the best – concise, easy to understand, compliant and the formatting is so professional. Top-quality service is provided every time. Thanks again
ISO Consulting Services is a one-stop solution for all my registration issues. The Guys working there are awesome and thanks to Mr.Arash for having a great team up there. They are very focused on delivering high-quality services to clients and they always meet and exceed clients’ expectations. Very happy with their services. Good on you guys.
Rihanna conducted our internal audit and assisted greatly in ensuring our documentation was up to date. She is pleasant person, easy to work with and we very much appreciate her expertise, advice and input. Thank you Rihanna.
We recently engaged the services of ISO Consulting to assist us in our preparation for recertification of ISO and HACCP accreditations. The guidance, sharing of knowledge and assistance provided by the ISO team ensured we were well prepared and of course passed our audits. I was very impressed with the professionalism and support from start to completion. I would highly recommend their services.
We have used ISO Consulting Services for a number of years and have nothing but good experiences and our last project and the ongoing projects we have with Arash and Rihanna is no exception nothing but praise for the team at ISO Consulting Services, we are happy to recommend their services.
On behalf of Eagle Lighting Australia, I would like to thank ISO Consulting Services for their great services. Arash and his team helped us to implement IMS (ISO 9001, ISO 14001, OHSAS 18001 and AS/NZS 4801) in 2017 and last week we had another big achievement in upgrading our OH&S management system to new standard ISO 45001:2018. I highly recommend the team at ISO Consulting Services.
We recently completed an IMS development project for three ISO certifications with ISO Consulting. Whilst faced with COVID-19 challenges, with the help of the team at ISO Consulting, we were able to get through the process. I found the team very helpful and responsive. They have excellent knowledge and supported me through the process. I also appreciated Arash’s guidance and advice throughout the journey. He genuinely wants the best outcome for his clients and addresses concerns and challenges quickly and promptly. I highly recommend the team at ISO Consulting. Thanks team!
It was a pleasure to work with Arash and Yann
I’m very happy with ISO Consulting Services. It was great to work with Arash and the team from the initial consultation to developing our IMS System. Thanks to their continued support over the years in keeping our ISO accreditation. Great work Arash and the team.
We recently used ISO Consulting for our NDIS Verification audit and with their help passed wonderfully. The consultants were very helpful and professional and supported us through the entire audit process. We are very satisfied with their work and results, and would highly recommend their services. Thank you Arash and Ali.
Thank you to ISO Consulting Services, particularly Rihanna, who provided great support and assistance to our staff regarding company IMS maintenance, development and education. All questions were answered and any issues encountered were resolved to our satisfaction. I would recommend ISO Consulting Services to other companies looking to introduce this increasingly important company and management tool.
I would highly suggest this service as they are quick and guarantee their work.
ISO consulting were above and beyond supportive throughout our registration process. we we very overwhelmed at times and Arash was always available to re assure us of the process and very prompt in his responses. I would definitely recommend , especially if your knowledge is minimal regarding the processes and we will most certainly recommend them to others seeking support and use them again if ever the need arises
I am very satisfied with the service and one on one assistance that I received in purchasing the ISO Consulting Package. Rihanna was amazing, answering all my queries etc. This is such an amazing service that I would recommend 100%. Thank you ISO Consulting Services
This is an excellent service that is provided. The feedback from my auditor was that it was one of the best and most refined audits she had sat which was largely due to packages I had purchased. I’m extremely grateful to have found this resource.
Responsive even after hours and provides professional service. Good value for money.
Professional services, capable staff. Staff members are very helpful. They will go out of there way to provide you with all the necessary documents you require to register your aged care and disability organisation. I’ve also trusted their products as it will certainly make your auditing experience a breeze through. Keep up the great job ISO consulting!
I would like to highly recommend ISO Consulting Services and team for their support, knowledge and educational guidance for Aged Care Consulting service. Mr Arash is very knowledgeable and pleasure to deal with as he replies patiently for all our queries and provides clear information and always going above and beyond for any assistance and easily approachable. Such a delightful experience and amazing service.
We want to thank particularly Dawood & Arash for assisting us with our application process for Home Care. It was a very stressful moment as we wanted to meet deadlines in submitting the application. ISO Consulting Services made this possible. ISO Consulting Services is very professional with clients and they deliver what they promise. As a small company, we have dealt with three other Consulting companies all claiming to be experts in Aged Care & NDIS industry but we ended up with significant financial losses and substandard Procedure Manuals/Application packs. If you want to progress with your business – Home Care/NDIS, consider ISO Consulting Services. They took our stress as theirs.
It was an absolute pleasure to work with ISO Consulting services. A considerate, supportive, honest and credible team. I will recommend ISO Consulting Services to any business that would need their services. Thank you for all your help and support.
ISO team are a very responsive set of professionals with the sole aim of helping the client succeed. We passed our NDIS audit in flying colours thanks to ISO Consulting Services. Highly recommended. Thumbs up.
ISO Consulting took their time and expertise to explain everything I needed to complete my application to become an NDIS Provider. I highly recommend them to anyone wanting to become a provider. Their knowledge is thorough, and they have very kind and professional staff who are highly skilled at what they do . I wish them all the very best for the future.
We are the happiest customer of ISO Consulting Services. ISO Consulting has helped us very well on our registration of NDIS Provider. Thank you to team. Also, lot of information regarding NDIS has shared though it was not covered under scope of services. I highly recommend their services.
I shopped around for consulting services for NDIS registration and landed with ISO consulting and never looked back. Arash and Rhinna were the best. Precise to the point and helped me so professionally and no hidden cost what so ever all upfront. took some time for NDIS to finalise my matter with out any re submission. ISO documents and template were the best and perfect and it was easy to use and amend with my logo. I strongly recommend their services. calls were returned promptly and I know where to go for consulting services falls under ISO banner. thank you the A1 team at ISO Consulting. Praba
The ISO Consultants could not have been more patient or kind helping prepare me for the NDIS application process – a process way out of my comfort zone – made easy by ISO.
Could not recommend this company enough. I dealt with Rihanna and Arash for NDIS Gold Audit Verification Package and I was very confused in regards to the process and everything before speaking with them. The responses were prompt, extremely helpful throughout the whole process and went above and beyond with meeting timelines and assisting with best prices and auditors and made such a complex thing so simple. Thank you so much and our apologies on the delayed review!
Recently used ISO Consulting for our NDIS Stage 1 Certification and Passed with compliments on how good the documents were. Easy to follow Fully instructed and I feel good value for money. Thanks Arash
I was worried about the whole application for the NDIS, ISO Consulting Services had a great system and made my life easier. Rihanna was absolutely amazing and so helpful. I am really happy I went with ISO Consulting Services.
We are a small business providing service to NDIS participants in the Warrnambool area. I am most impressed with the service I received from ISO Consulting Services and Rihanna who was professionally and easily able to assist me in renewal register with the new NDIS registration upgrade. This was a complicated and very time-consuming registration seeing me work some 5-6 hrs researching and noting in an attempt to execute myself. Working with Rihanna saw this registration seamlessly completed in an hours’ time. I recommend anyone seeking support to contact Rihanna for help. You will not be disappointed!!
ISO Consulting services are very professional and affordable, will recommend to you as they will guide you every step of your journey. Caring, thoughtful and very professional service. Went above and beyond to assist. Highly recommended.
ISO Consulting services are very professional and affordable, will recommend to you as they will guide you every step of your journey.
ISO was very helpful from the time we contacted them till the time of registration. They were customer centered and very supportive. We have recommended to other. Thanks
We decided to implement an Integrated Quality and Environmental Management System to ensure we approached the Olympics using world’s best practice programs. We knew the international community would expect the best – and so did we. We searched for Australia to find the best consultancy available and the decision to appoint ISO Consulting was the best we ever made. They quickly became part of the team and implemented the system quickly and professionally.
