One class decision changes cost and timeline. We get the first step right.
Medical devices follow a registration route set by risk class (Class 1 to 4); IVDs use their own classification rules. PartnerHub handles classification, registration and post-market duties.
Contact us- Government fee
- Varies by device class
- Registration service
- from THB 24,000 per registration
- Renewal
- from THB 24,000 every 5 years
How it works
- 1
Class determination
The risk class (Class 1 to 4) sets the route, documents and timeline.
- 2
CSDT dossier
Device data assembled in the ASEAN common format (CSDT).
- 3
Application and review
Filed under PartnerHub.
Varies by class - 4
Post-market duties
As license holder we carry out post-registration duties such as adverse event reporting.
Renewed every 5 years
Documents to prepare before filing
01CSDT device data
ManufacturerDescription, specifications and performance data in the common format.
02LOA and copies of foreign approvals
Brand ownerLOA in the Thai FDA format; foreign approval history as certificate copies.
03ISO 13485 or other manufacturing certificate
ManufacturerA copy of the certificate held by the manufacturer.
04Instructions for use (IFU)
PartnerHub supportThai for lay users; at least English for professional users.
05Clinical or performance data (if applicable)
ManufacturerRequirement depends on class and product.
What PartnerHub handles
- Step 1
Registration
Class determination, CSDT and registration at published prices.
- Step 2
License holding
As license holder, PartnerHub carries out post-market duties.
- Step 3
Import and distribution
As importer of record (IOR), we connect customs clearance, storage and medical channels.
Cost
| Item | Price | Note |
|---|---|---|
| Government fee | Varies by device class | Shown as a separate line after the class is determined |
| Registration service | from THB 24,000 per registration | Starting price by device class |
| Renewal | from THB 24,000 every 5 years | By 31 December of the fifth year from the year of issue |
VAT is separate and depends on the contracting entity. Government fees are charged at cost and shown as separate lines.
Frequently asked questions
What are the most common reasons for rejection?
01 Wrong class: Misjudging the line between device, drug and cosmetic is a frequent failure. 02 Missing CSDT items: Missing description or evidence items lead to deficiency letters or rejection. 03 IFU language or content gaps: Language rules by user type and mandatory content must be checked together. PartnerHub checks these first in the pre-filing completeness review.
Who applies for medical device registration?
Under Thai rules only a business registered in Thailand can be the license holder. PartnerHub becomes the holder and files the registration; your rights are set out in the contract.
What costs are there besides government fees?
The registration service fee and the renewal fee every 5 years, shown in the cost table above. Government fees and service fees are always shown separately, and costs such as translation or labels are itemised in advance.
What if some documents are missing?
We check completeness before filing. Missing items come back to you as a checklist, and for documents that need the manufacturer’s help we prepare the request wording. This is faster than refiling after a rejection.
How does renewal work?
The license is renewed every 5 years, by 31 December of the fifth year from issue. We notify you in advance and carry out the renewal.
Tell us about your medical device products.
We reply within 1 business day with the documents and costs.
Contact us