Insight

Manufacturing medical devices in Thailand: preparation before premises registration

Requirements for the proposed manufacturing activity, premises and product classification need separate examination. Registration or licensing at one level should not be taken to mean that every product and all business activities have completed market-access procedures.

Are premises procedures and product procedures the same?

Requirements for the proposed manufacturing activity, premises and product classification need separate examination. Registration or licensing at one level should not be taken to mean that every product and all business activities have completed market-access procedures.

Which records should correspond to the actual site?

Organise production and storage addresses, layouts, processes, equipment and environmental-management documents, responsible-person information and the product range. Areas, workflows and management arrangements described in the documents should match the actual site rather than being assembled from another factory's materials.

What if changes occur later?

A change of premises, responsible person, process or product range should prompt a timely check of amendment requirements. THAIHOUSING can coordinate documents and application communications; testing and other specialist matters are handled by external organisations. The work follows the specific product and premises requirements.

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