Medical Device Registration Support in ASEAN Countries
At MedQCompliance, we offer comprehensive end-to-end support for medical device registration across ASEAN countries, including Singapore (HSA), Thailand (Thai FDA), Malaysia (MDA), Indonesia and the Philippines (MoH), through your identified distributor or our network of trusted regulatory partners.
What's included in
Medical Device Registration Support
Our services cover the entire registration journey — from technical documentation preparation, product classification as per ASEAN regulations to direct submission to the respective regulatory authorities.
Regulatory Strategy & Preparation
Our steps include strategic planning of verification and validation (V&V) studies such as clinical validation and compliance testing.
Verification, Submission & Compliance
We further support human factors/usability engineering, software verification, and cybersecurity assessments, leading up to direct submission to the respective regulatory authorities.
Ongoing Regulatory Support
We continue to support you by addressing regulatory queries until final clearance is achieved.
Streamlined Submission Process
By streamlining the submission process and proactively managing potential regulatory hurdles, we help our clients significantly reduce the time to approval.
Accelerated Market Access
With MedQCompliance, you gain a smoother, faster, and more predictable path through regulatory review, allowing you to focus on getting your product to market without delays.
Partner with us to simplify your ASEAN market entry with confidence and efficiency.
Unlock regulatory mastery, ensure quality compliance, and expedite market entry. Elevate your MedTech success story with our tailored solutions and expert guidance.
Frequently Asked Questions
Get quick answers to common questions about MedQ Compliance’s services and Medtech regulatory consulting.
You can connect with us through our website, LinkedIn, Google search, or referrals to schedule an initial consultation.
MedQ Compliance specializes in preparing a tailored regulatory strategy for your medical device solution, support in building technical documentation and completing regulatory submissions in global markets such as US FDA, EU MDR/ IVDR, CDSCO India, Singapore HSA, and other countries.
MedQ Compliance prioritizes confidentiality, implementing secure processes for information protection.
Timelines for regulatory approvals depend on multiple factors such as completeness of the technical dossier, meeting applicable requirements and timely communication with the regulatory bodies. MedQ Compliance optimizes all these key areas that ensure high efficiency and minimal timelines for regulatory clearances.