Client intake
Create an account and tell us the product type, intended market, company context, manufacturer, and regulatory target.
Medical device regulatory dossiers
Clarity for the climb to market access.
Everest Nova turns complex product evidence into expert-reviewed regulatory dossiers for Singapore and Malaysia—securely, methodically, and with medtech expertise at every stage.
From SGD 4,999 · Class D SGD 6,999
Singapore and Malaysia market focus
Expert-reviewed medical regulatory dossiers
The problem
Distribution rights are not enough.
Singapore and Malaysia submissions are complex. We add the local structure and market knowledge needed to turn scattered files into a clear dossier package.
Company, product, and manufacturer files in different places
Different HSA and MDA expectations
Local market knowledge missing from the team
Portal
A simpler way to move the dossier forward.
Your team gets one place to upload files, answer questions, track status, and download the final package.
Client portal
Dossier in progress
UploadSource files
ReviewNova checks
ExpertMedtech review
PrepareDossier package
DeliverClient download
Files
Messages
Deliverables
Upload all source documents
Upload your company information, product details, manufacturer-provided documents, labels, IFUs, certificates, quality files, and evidence.
Everest Nova document review
Everest Nova organizes the material, checks what is present, identifies missing information, and prepares follow-up questions where needed.
Medtech expert review
In-house medical technology specialists review the source material and project context before dossier preparation begins.
Where we help
Medical device dossiers.
We prepare regulatory dossiers for medical devices, including IVDs, diagnostic products, and point-of-care devices, for Singapore and Malaysia market access.
Singapore medical device registration support
Support for device classification, evidence organization, product technical files, labeling, importer/dealer context, and HSA registration preparation.
Malaysia medical device dossier support
Preparation support for MDA medical-device registration, CSDT-style evidence, establishment context, classification, labeling, and MeDC@St submission readiness.
Next phase
Pharmaceutical dossier preparation
Planned for a future phase and not part of the current service offering. Contact us to register your interest.
Credibility
Built from Singapore medtech experience.
Everest Nova is rooted in Singapore and connected to Everest Links Pte Ltd, an ISO13485 and GDPMDS certified company with 15 years in medical devices and diagnostics.
Visit Everest Links parent websiteSingapore
home base for regional Singapore and Malaysia market access work
15 years
medical device and diagnostics experience through Everest Links
ISO13485
quality-management certification foundation
GDPMDS
Singapore good distribution practice medical device systems foundation
Expert review
medtech specialists review the material before dossier delivery
Pricing
From SGD 4,999 per dossier preparation.
Class A-C medical devices are SGD 4,999; Class D medical devices are SGD 6,999. Regulator fees and other external costs are separate.
Included
Secure client account
Document intake checklist
Everest Nova document review
Medtech expert review
Dossier package preparation
Final downloadable files
Everest Nova prepares documentation packages for client submission and does not guarantee regulatory approval. Approval outcomes depend on the product, evidence quality, data completeness, manufacturing controls, and the independent assessment of the relevant authority.
Ready to turn your files into a dossier package?
Start with a secure account. Upload your files. We take it from there.