Southeast Asia | 디엔에이테크퍼시픽-DNA TECHNOLOGIES PACIFIC                        
DNA Technologies Pacific

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Product certification

CS Center

Tel. 02-6749-1161

AM 9:00 ~ PM 6:00

* Saturday,Sunday,Holiday : Days Off

Fax 02.6749.0711

Southeast Asia

Southeast Asia

Southeast Asia

Medical device registration in Thailand

In order to manufacture, import and distribute medical devices in Thailand, companies must be pre-registered with the Food and Drug Administration of Thailand (FDA). The Thai Food and Drug Administration categorizes medical devices into three categories: General Medical Device, Notified Medical Device, and Licensed Medical Device.

Taiwan medical device registration

In order to export medical devices to Taiwan, it must be approved by the Taiwan Ministry of Health.


  • 01Safety and efficacy clinical trials for CE certification of medical devices

  • 02PMCF progress on CE certified medical devices

  • 03Support the PMCF Plan, Protocol, and Investigator's Brochure

  • 04Collect health and economic data to obtain approval for reimbursement

  • 05System and product certification technical support

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