GRZAN Medical Device Registration Services in Thailand

GRZAN covers the complete chain from market access to ongoing compliance in Thailand through six service modules. This page summarises the six modules, explains why GRZAN operates its own Thai entity rather than subcontracting, describes how a project starts, and sets out plainly what can and cannot be promised about approval outcomes.

1. Key takeaways

GRZAN’s Thailand services cover the full chain from market access to ongoing existence, organised into six modules: feasibility assessment and classification determination; licence-holding structure design; institutional licence and site compliance; technical dossier preparation; submission and import; and post-market and annual maintenance. The distinguishing feature is that the Thai entity is owned and operated by GRZAN itself, GRZAN GROUP CO., LTD., registered with the Department of Business Development under number 0105568233160, which enables the combined compliance structure of licence holding, importing and payment collection in a single entity. GRZAN does not promise guaranteed approval; what it commits to is certainty of process.

• Six modules. Feasibility and classification; licence structure; institutional licence and site compliance; technical dossiers; submission and import; post-market and annual maintenance.
• Own entity. GRZAN GROUP CO., LTD., Department of Business Development registration number 0105568233160, acts as independent licence holder and importer.
• Three-step start. Free preliminary assessment, a Thailand registration feasibility assessment report, and then launch of the institutional licence and dossier preparation.
• No guaranteed approval. GRZAN commits to certainty of process, not to guaranteed certification.

2. Legal basis

The services are anchored in the Thai regulatory framework: the Medical Device Act B.E. 2551 (2008) and the Medical Device Act (No. 2) B.E. 2562 (2019); the MoPH classification notification B.E. 2562 (2019), the vigilance notification B.E. 2563 (2020), the GMP notification B.E. 2566 (2023) and the labelling notification B.E. 2568 (2025); the Thai FDA commercial purpose process, Steps 1 to 7, together with the official fee schedule; the Thai FDA reliance pathway notification of 4 June 2024 (B.E. 2567) and the Malaysia MDA accession notification of 6 October 2026; the transfer notification of 19 September 2024; and the unified renewal system of July 2025, operated in SKYNET with the window from 1 October to 31 December each year. Classification under the services follows the MoPH classification notification B.E. 2562 to determine Class 1 to 4, with written classification conclusions and the rule basis documented, and with identification of whether the product qualifies for positive-list automatic approval for Class 1, the Abridged route with reference-country approval held for one year, or the Reliance route through Singapore HSA or Malaysia MDA without a holding period.

3. Expert insights

The six modules in detail. Feasibility assessment and classification determination applies the MoPH classification notification B.E. 2562 to determine Class 1 to 4 and issues written classification conclusions with the rule basis. Licence-holding structure design compares three models: distributor-held licences, an independent licence holder, and establishing a Thai company, with GRZAN’s own subsidiary GRZAN GROUP CO., LTD. serving as the independent licence holder and importer to realise the combined structure of licence holding, importing and payment collection. Institutional licence and site compliance covers the importer institutional licence, including site inspection preparation, GDPMD system maintenance, and warehouse and personnel conditions. Technical dossier preparation covers Class 2 to 4 dossiers in CSDT format, including the executive summary, the Essential Principles checklist answered item by item, the risk analysis traceability matrix, verification and validation, and the clinical evaluation report, together with Thai-language labels and instructions for use conforming to B.E. 2568: Thai for home use, Thai or English for professional use, the eight required elements, UDI and electronic instructions for use. Submission and import covers e-Submission filing and status tracking, per-shipment LPI import licences, and parallel NBTC approval for wireless devices. Post-market and annual maintenance covers vigilance and FSCA reporting on the 48-hour, 10-day, 30-day and 21-day follow-up cycles, advertising licence number applications, changes and transfers, renewal window management each October to December, ISO 13485 and certificate expiry tracking, and quarterly review of the regulatory ledger.

Why own operations rather than subcontracting matters in Thailand specifically is that Thai law requires licence holding, importing and payment collection to be the same entity. Four points follow. The Thai entity is directly established and operated by GRZAN, not through overseas third-party subcontracting, so registration, licence holding, importing and vigilance all remain in one pair of hands, the service chain has no gaps, and there is no layering of margins. The authorisation relationship is transparent: the certificates are held and controlled by GRZAN, so the manufacturer can adjust the channel structure at any time, and if the licence holder ever needs to change, GRZAN cooperates through the Thai FDA Transfer process and provides the required documents, including the consent letter of the original holder, rather than leaving the manufacturer waiting passively on someone else. Tax and fund flows are compliant: licence holding, importing and payment collection sit in the same own entity, VAT is accrued in Thailand, and there is no tax exposure from funds bypassing Thailand. The local team works directly with the domestic registration professionals without time zone or language barriers, and the Thai team is familiar with the review habits and practical interpretation of the MDCD, allowing issues to be anticipated in advance.

4. Practical recommendations

• Starting a Thailand project takes three steps. First, a free preliminary assessment: provide the product name, intended use, registration status in the country of origin, including whether NMPA, CE, FDA, Singapore HSA or Malaysia MDA approval exists, and the list of target models.
• Second, GRZAN issues the Thailand registration feasibility assessment report, containing the classification conclusion, the pathway selection covering listing, notification or licence plus whether an accelerated route is available, a cycle estimate and the fee composition.
• Third, once the plan is confirmed, the institutional licence and dossier preparation are launched.
• On outcomes, GRZAN does not promise guaranteed approval or a hundred percent certificate rate. What it commits to is certainty of process: classification conclusions with a rule basis, CSDT dossiers closed item by item, the institutional licence site inspection passed in one attempt, Thai localisation conforming to B.E. 2568, and vigilance and renewals traceable in the ledger. The Thai review outcome depends on dossier quality and the sufficiency of the product’s own evidence, and doing the process thoroughly is the only reliable way to raise the pass rate.
• Before launching, answer four questions: which classification tier the product falls into under the MoPH classification notification; whether Singapore HSA or Malaysia MDA approval exists, enabling the reliance route without a holding period; which licence-holding model to use and what the cost of changing distributors three years later would be; and, working backwards from the target launch date, whether the institutional licence site inspection can be scheduled in time. Answering these four questions completes half the project.

5. Verification checklist

• □ Confirm the Medical Device Act B.E. 2551 (2008) and the Medical Device Act (No. 2) B.E. 2562 (2019).
• □ Confirm the MoPH classification notification B.E. 2562 (2019), vigilance notification B.E. 2563 (2020), GMP notification B.E. 2566 (2023) and labelling notification B.E. 2568 (2025).
• □ Confirm the Thai FDA website process under For Commercial Purpose, Steps 1 to 7, and the official fee schedule.
• □ Confirm the Thai FDA reliance pathway notification (2024-06-04, B.E. 2567) and the Malaysia MDA accession notification (2026-10-06).
• □ Confirm the transfer notification (2024-09-19).
• □ Confirm the unified renewal system (2025-07, SKYNET, from 1 October to 31 December each year).
• □ Confirm GRZAN GROUP CO., LTD., Department of Business Development registration number 0105568233160.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com