Following the Ministry of Public Health Notification B.E. 2562 (2019) regarding alcohol-containing products intended for disinfection of humans, animals, and medical devices, the Medical Device Control Division has undertaken a comprehensive review of such products.
This review included the issuance of notification certificates and the evaluation of supporting documentation required for regulatory submissions.
To ensure consistency, safety, and performance in alcohol-containing disinfectant products, the Medical Device Control Division has developed guidelines for the preparation of documentation related to design verification and validation.
Read the full guidance here: กองควบคุมเครื่องมือแพทย์
Purpose of the Guidelines
To assist manufacturers and importers in preparing compliant submissions for alcohol-containing disinfectant products.
To provide Thai FDA officers with a clear framework for assessing design verification and validation documentation.
To strengthen the overall regulatory process by ensuring that verification and validation evidence is properly documented and aligned with international best practices.
Scope of Application
These guidelines apply to alcohol-containing products intended for disinfecting purposes for:
- Humans
- Animals
- Medical devices
The products are intended for skin disinfection of humans or animals, or disinfection of medical devices, and fall within the scope of both drugs and medical devices.
Key Highlights
Safety Documents and Pre-Clinical Study Results
The guidance clarifies the expected safety and pre-clinical documentation for alcohol-containing disinfectant products.
The pre-clinical test results may include:
- Biocompatibility test results
- Pre-clinical physical test results
- Pre-clinical animal study results
However, based on FDA’s assessment, biocompatibility testing under medical device standards is not required for submission for these products.
The following tests are not required:
- ISO 10993-5: Tests for In Vitro Cytotoxicity
- ISO 10993-10: Tests for Skin Sensitization
- ISO 10993-23: Tests for Irritation
Raw Material Requirements
Pharmaceutical-grade raw materials should be selected to reduce contamination risk, including:
- Ethanol or isopropyl alcohol
- Purified water
- Purified cotton
A Certificate of Analysis (CoA) should be provided for pharmaceutical-grade raw materials, including alcohol, water, and cotton.
Stability Study Requirements
Stability studies are required to demonstrate the shelf life of the product and confirm that it maintains the required quality and standards throughout the storage period.
Stability studies must be conducted in accordance with the ASEAN Guideline on Stability Study of Drug Product, or equivalent national or international standards.
Both accelerated and long-term stability studies are required.
At minimum, the following test items must be included:
- Water loss, where applicable for permeable or semi-permeable packaging
- Alcohol content
- Microbiological examination
Alcohol Content
Alcohol content must be determined using a reference method from the pharmacopoeia proclaimed by the Minister under the law on drugs, or an equivalent method.
The acceptance criterion should be set at 95–105% of the labeled alcohol content, reported as % v/v, and the alcohol content must be not less than 70% v/v.
Microbiological Examination
The following microbiological attributes must be tested:
- Total Aerobic Microbial Count (TAMC)
- Total Combined Yeasts/Molds Count (TYMC)
- Staphylococcus aureus
- Pseudomonas aeruginosa
Clinical Performance Documentation / Clinical Evidence
For alcohol-containing disinfectant products containing ethanol or isopropyl alcohol at ≥70% v/v combined with water only, in saturated alcohol form, submission of clinical evidence is not required due to their long history of use in disinfection.
Clinical performance documentation or clinical evidence is therefore not required.
Testing Laboratories
Stability testing may be performed at the manufacturer’s own facility, provided it holds national or international production quality certification for this product.
Alternatively, testing may be contracted to an external laboratory. External laboratories must be accredited to ISO/IEC 17025 or an equivalent standard, with scope covering the relevant test methods.
All test methods must have undergone method verification or method validation, as applicable.
Implications to Stakeholders
Manufacturers and importers must align product documentation with the new Thai FDA requirements to obtain or maintain product registration.
Clients and registrants must comply with the guideline from 15 May 2026 onwards. Non-compliance may result in delays or rejection of product registration.
Registrants of alcohol-containing medical devices should review their current submission packages and ensure that safety documents, stability data, raw material documentation, and laboratory testing arrangements are prepared in accordance with the guideline.
Effective Date
15 May 2026 onwards
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.