Thailand
Definition of medical devices
Under the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), a medical device is defined as follows.
""Medical Device” means:
- An instrument, tool, mechanical device or object that is used for insertion into body, fluid for laboratory examination, product, software or any other object specifically intended by the manufacturer or the product owner for one of the following uses with a human or animal body, either solely or as a constituent or accessory of any other object:
a. diagnosis, prevention, monitoring, treatment, relief or cure of disease;
b. diagnosis, monitoring, treatment, relief or cure of injury;
c. inspection, replacement, remedy, alteration, support, sustainment or aid pertaining to the anatomy or body process;
d. life support or aid;
e. contraception or promotion of fertility;
f. assistance or compensation for a disability or handicap;
g. g.generation of data from the examination of specimen extracted for medical or diagnostic purposes; or
h. disinfection or sterilization of medical device.
2. An accessory to be used together with the medical device under (1); or;
3. Other instrument, tool, mechanical device product or object as prescribed by Notification of the Minister as medical device.
The accomplishment of purposes of the articles stated in (1) which occurs within a human or animal body must not be the result of a pharmacological, immunological or metabolic process.
Classification
| Type | Risk level |
| 1 | Low risk |
| 2 | Low to moderate risk |
| 3 | Moderate to high risk |
| 4 | High risk |
Competent Authorities and Registration Process
The competent authoty that licenses and regulates the circulation of medical devices is the Medical Devices Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA).
Options for registration applicant
Our Services
Registration service
Registration service
With a team of experts deeply knowledgeable in local regulatory requirements and extensive hands-on experience in medical device registration, MedNovum is willing to accompanie enterprises through every step — from document preparation to achieving results — ensuring a registration process that is accurate, efficient, and timely.
Marketing Authorization Holder (MAH) Service
Marketing Authorization Holder (MAH) Service
If businesses are concerned about the cost of establishing a legal entity in Thailand, and do not want to entrust the exclusive market to a distributor, MedNovum offers a more flexible and optimal solution for businesses. With the presence of a reputable partner in Thailand, MedNovum provides a circulation number entrustment representative service, supporting businesses in submitting registration applications as directed, while still ensuring the right to proactively manage the market and products.
Regulatory Compliance Consulting Service
Regulatory Compliance Consulting Service
-Language barriers and the complexity of local regulations often pose challenges for enterprises entering new markets. Don’t worry — with MedNovum’s specialized consulting services, we ensure your compliance from the initial market entry stage through post-market activities.
MEDNOVUM
YOUR COMPREHENSIVE PARTNER IN THE MEDICAL DEVICES SECTOR
HUMAN RESOURCES
MedNovum brings together a team of experienced experts, including lawyers, pharmacists, and engineers who are extensively trained in the field of medical devices. With a strong knowledge base and deep understanding of legal regulations, technical procedures, and market requirements across multiple countries, we are confident in delivering comprehensive, accurate, and effective service solutions to every client. The combination of legal expertise and technical proficiency is what sets MedNovum apart, making us a trusted partner for many years.
ISO CERTIFICATE
Achieving the ISO 9001:2015 certification is an important milestone in MedNovum’s development journey. This achievement shows our strong commitment to maintaining high-quality services, meeting customer expectations, and strengthening MedNovum’s position in the medical device market.
NUMBER OF YEARS OF EXPERIENCE
With over 10 years of experience in the medical device industry, we understand the needs and challenges that businesses face. MedNovum is committed to providing professional, accurate, and reliable services – helping our clients save time, ensure regulatory compliance, and improve business performance.