THAILAND: Thai FDA's Applicable Conditions and Criteria for Expedited Medical Device Registration Routes – May/June 2023

2023-05-24

The Thai FDA (Thailand Food and Drug Administration) has implemented expedited routes for medical device registrations to accelerate the approval process and provide faster access to innovative medical technologies for patients in Thailand. The expedited routes include the Concise Evaluation, the Reliance Program, and the WHO CRP for IVD routes, which have specific applicable conditions and criteria that medical device manufacturers must meet to be qualified for each expedited registration.

Expedited Route

Condition

Reference Agency

Advantages

Concise Evaluation
  • ● Class 2-4 or B-D
  • ● 1 approval from a reference agency for at least one year
  • ● Full CSDT submission required
  • ● Big 5 countries: Australia, Canada, Europe, Japan, USA
  • ● Shorten the registration time by roughly 1/3
  • ● Reduced registration costs1

Reliance Program
  • ● Class 2-4 or B-D
  • ● Approval in Singapore
  • ● Same CSDT submitted to Singapore HSA
  • ● Singapore (HSA)
  • ● Shorten registration time from 150 to 60 working days
  • ● Reduced registration costs1

WHO CRP2 for IVD
  • ● Class 2-4 or B-D of IVD
  • ● IVD kit registered in WHO prequalification (WHO PQ)
  • ● IVD kit3
  • ● Exclusion: HIV, Methamphetamine and COVID-19 test kits
  • ● WHO Prequalification
    (WHO PQ)
  • ● Shorten registration time from 250-300 to 30 calendar days
  • ● Reduced registration costs1

1 Registration costs for the expedited routes will be reduced by 53,000 baht (depending on their risk classification), a fee waiver on the expert review process.

2 CRP: Collaborative Registration Procedure
3 IVD Kit i.e. Malaria, Hepatitis C, Hepatitis B, HPV, G6PD, Cholera, Syphilis, Tuberculosis NAT, Haemoglobin POC, Glucose meters & test strips.


In conclusion, by meeting these conditions and criteria, medical device manufacturers can benefit from shortened review times and faster approval processes, which enhance patient access to new and innovative medical technologies.

 

 

References:
Specialist Review and Concise Evaluation Criteria - Thai FDA Official Website
Thailand FDA - HSA Singapore Regulatory Reliance
Thailand FDA – WHO Collaborative Registration Procedure (CRP) for in v itro diagnostics (IVDs)

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TAG : Thai FDA Registration , Expedited Route , Medical Device registration , Concise Evaluation , Reliance Program , WHO CRP for IVD , Risk – classification

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