Questions
Frequently Asked Questions
Common questions about our medical device registration services.
How long does the medical device registration process take?
Registration timelines vary depending on device classification and target market. Class A devices can typically be registered in 2-4 months, while Class C and D devices may take 6-12 months. Our pre-submission preparation helps minimize delays during authority review.
What documentation do you need from us to begin?
We typically need your device specifications, intended use information, existing regulatory approvals (FDA, CE, etc.), quality management system documentation, clinical evidence (if applicable), and labeling information. We'll provide a detailed checklist after our initial consultation.
Can you handle multi-country registrations simultaneously?
Yes. We specialize in coordinated multi-country registration strategies across ASEAN and global markets. We can optimize your dossier to meet requirements across multiple jurisdictions, reducing duplication and accelerating regional market access.
What happens if our application is rejected or requires changes?
Our team manages all authority queries and clarification requests promptly. We help you prepare comprehensive responses and additional documentation as needed. Our pre-submission gap analysis minimizes the likelihood of significant issues during review.
How much does medical device registration cost?
Costs vary based on device class, target markets, and complexity. Government fees, professional service fees, and testing costs (if required) all factor into the total. Contact us for a customized quote based on your specific products and goals.
Do you provide post-registration support?
Absolutely. We provide ongoing post-market support including registration renewals, variations, vigilance reporting, regulatory updates, and compliance monitoring. Many of our clients work with us as their long-term regulatory partner.
How quickly will you respond to my inquiry?
We generally respond to all inquiries within 2 business days. For urgent matters, please mention "URGENT" in your message subject
Can we meet in person at your office?
Absolutely. We welcome in-person meetings at our Penang office by appointment. Please contact us to schedule a visit at a time that's convenient for both parties.
Do you offer services outside business hours?
For our international clients across different time zones, we can arrange meetings outside standard business hours upon request. Please mention your preferred meeting time in your inquiry.
What information should I prepare before contacting you?
The information that we require is in accordance to the form here