Thailand Medical Device Registration

Regulatory Authority: Thai Food and Drug Administration (FDA)

The Thai Food and Drug Administration, established in 1979 under the Ministry of Public Health, stands as a crucial sentinel in safeguarding the health and well-being of Thai citizens. Its mission is clear: to ensure the safety, quality, and efficacy of food, drugs, and other regulated products in Thailand. This encompasses a wide range of responsibilities, from setting stringent standards and regulations to meticulously monitoring the production, import, and distribution of these products.

The FDA’s reach extends far beyond just food and drugs. Its comprehensive mandate encompasses a diverse array of products, including:

• Medicines: Ensuring the safety and efficacy of all drugs, from prescription medications to traditional herbal remedies.
• Food: Protecting consumers from foodborne illnesses and adulteration by setting rigorous standards for food safety and hygiene.
• Cosmetics: Overseeing the quality and safety of cosmetics to prevent harmful chemicals and misleading claims.
• Medical Devices: Regulating the use and safety of medical devices, from pacemakers to surgical instruments.
• Narcotic Drugs and Psychotropic Substances: Controlling the production and distribution of these substances to prevent abuse and addiction.
• Hazardous Substances: Minimizing the risks associated with hazardous chemicals and materials.

The FDA’s role goes beyond mere regulation. It actively promotes public health by:

• Providing consumer education: Educating the public about safe food and drug practices, raising awareness about potential risks, and empowering them to make informed choices.
• Conducting research and development: Engaging in research to improve food and drug safety standards, develop new regulations, and stay ahead of emerging health threats.
• Collaborating with international partners: Working with other countries and international organizations to share knowledge and best practices, ensuring global food and drug safety.

Link for Regulatory Authority: https://en.fda.moph.go.th/

Local Regulation: Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2)

What is a Medical Device?

Medical devices under the Medical Device Act, B.E. 2551 (2008) and its amendments, means:

1. Any instrument, apparatus, machine, implant, in vitro reagent that used inside or outside laboratory, material, software, or related article intended by the manufacturer or product owner to be used in humans or animals, alone or combination for the specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation of human or animal diseases
• diagnosis, monitoring, treatment of or compensation for an injury in human or animal
• investigation, replacement, modification, or support of the anatomy or of a physiological process in human or animal
• supporting or sustaining life of human or animal
• control of conception or aid in the reproduction of human or animal
• aiding or compensation for the disability of human or animal
• providing information for medical diagnostic purposes by means of in vitro examination of specimens derived from human or animal
• disinfection of medical devices

Achievement of the purposes according to (1) in or on human or animal bodies must not be intended by pharmacological, immunological, or metabolic means.

2. Accessories pursuant to (1)

“Accessory” means the article, apparatus or product that is intended specially by its manufacturer or product owner to be used together with a particular medical device to enable or assist that device to be used in accordance with its intended purpose

3. Instruments, apparatus, machines, products, or other articles declared by the Minister as medical device such as Alcohol Pad, Breath-alcohol Test, Methamphetamine Diagnostic Test Device

Classification: Class I, II, III, IV

Listing or Registration Requirements:

• Manufacturer / Importer of Medical Devices for Commercial Purpose must obtain an establishment license and then must classify their device based on
• Class 1 must obtain Certificate of Listed medical Devices
• Class 2and 3 must obtain Certificate of Notified Medical Devices
• Class 4 must obtain Certificate of Licensed Medical Devices
• As per new medical device regulations each device registration pathway follows individual registration rules documents.
  • Class 1: Require less documentation
  • Class 2-4: Submission in Common Submission Dossier Template (CDST) format with list of necessary documentation
• Product registration of medical devices is to obtain marketing clearance for its import and supply in Thailand.
• Licensing of dealers is based on the activity carried out by the company. Only medical device dealers licensed can engage in the manufacture, import and/or wholesale of medical devices in Thailand.
• There are 3 pathways for medical device registration in Thailand:
  • Full evaluation
  • Concise pathway: This is a medical device registration method that expedites the registration process and reduces evaluation fees by requiring referral agency approval.
    • It is applicable for Class 2 – 4 devices
    • A medical device must undergo full evaluation and be marketed for over a year without any serious adverse events in one of six regulatory agencies.
      • EU
      • Health Canda
      • MHLW
      • TGA
      • US FDA
      • WHO
    • Trade name, model, product code, intended use, indication, label, instruction for use (IFU), packaging, name and address of physical manufacturer of medical device submitted through concise pathway must be identical as that approved by the reference agency
  • Reliance program: This is a medical device registration program that relies on the approval from health Science Authority (HSA), Singapore. This program aims to expedite the registration process and evaluation fees.
    • It is applicable for Class II – IV devices
    • Trade name, model, product code, intended use, indication, label, instruction for use (IFU), packaging, name, and address of physical manufacturer of medical device submitted through reliance pathway must be identical as that approved by the HSA
    • Required Documents:
      • The same registration dossier in the Common Submission Dossier Template (CSDT) as the one approved by HSA Singapore
      • Change notification document approved from HSA Singapore (If applicable)
      • Letter for joining Thailand FDA & Singapore HSA Regulatory Reliance
      • Approval evidence in Singapore
      • Thailand FDA & Singapore HSA Reliance Model Consent Form

Documents Required:

• Class I
• Class II and III
• Class IV
• Common Submission Dossier Template (CDST)
• ISO 13485 Certification
• Import License of the local representative

Registration Timeline:

• Class I – 200 Days
• Class II & III – 250 Days
• Class IV – 300 Days

Submission Fee:

• Class I: USD 17
• Class II, III and IV: USD 33

Approval Fee:

• Class I – USD 87
• Class II & III – USD 333
• Class IV – USD 667

https://thaimed.co.th/wp-content/uploads/2022/10/Medical-Device-Act-2nd-Edition-BE-2562-2019.pdf

License Validity: 5 years.

License Renewal: Products registered under the old rules will be permitted to renew one time with a partial application before undergoing full registration once the renewed license expires 5 years later. Documents required for partial applications vary depending on the renewal date.

Special Labelling Requirements: Labels for professional use devices are not required to have a Thai version. Home use devices should be labelled both in Thai and English

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]