Outsourcing Regulatory
Outsourcing Regulatory
In case your distributor does not have an in-house Regulatory team but would like to be the license holder, LHM has an outsourced team to register your product under their company name. We will be experts for your registration with the TFDA and give you an update about registration. In addition, our team also provides services for renew licenses for you, just like you have in-house teams.
Our Outsource Regulatory team will classify medical devices for you according to the regulations of the Thai Food and Drug Administration. It will be classified according to the intended use, level of risk, delivery method, and the degree of invasiveness in the human body.
Devices are classified into one of the following, from lowest to highest risk:
- Class 1
- Class 2
- Class 3
- Class 4
While classification rules closely align with the ASEAN MDD guidance, the Thai FDA has also included specific rules for each registration route.