Thailand’s Ministry of Public Health issued the Notification on Medical Device Standards to Be Complied with by Medical Device Manufacturers or Importers (B.E. 2569) on September 30, 2026, which was published in the Royal Thai Government Gazette on November 2, 2026.
This notification updates the mandatory medical device standards in Thailand, specifying the product standards that manufacturers and importers must comply with, and repeals and consolidates the previously relevant notifications.
The update covers 21 categories of medical devices, including surgical gloves, contact lenses, syringes, in vitro diagnostic reagents, injectable hyaluronic acid products, medical protective clothing, and medical masks.
It also sets out transitional arrangements for products already licensed, requirements for adapting to revised standards, and the handling of applications still under review.
1. Key Updates in This Regulation
The main changes introduced by this notification are concentrated in the following four areas:
1. Repeal of 4 Existing Related Notifications
Article 2 of the notification explicitly repeals the four previously issued medical device standards notifications:
- Notification on Medical Device Standards to Be Complied with by Medical Device Manufacturers or Importers, B.E. 2563;
- Notification No. 2 issued under the above notification, B.E. 2563;
- Notification No. 3 issued under the above notification, B.E. 2563;
- Notification No. 4 issued under the above notification, B.E. 2567.
This means that the previously relevant standards notifications are no longer independent instruments currently in force, and standards conformity assessments should thereafter be based on the 2026 new notification and its annex.
2. Mandatory Standards for 21 Categories of Medical Devices
The annex to the new notification lists 21 categories of medical devices and their corresponding standard bases. For the products listed in the annex, manufacturers or importers must comply with the corresponding standards.
3. Transition Period for Existing Products
For companies that had already obtained licenses, completed detailed submissions, or completed the relevant product notifications before the notification took effect, the notification provides a maximum one-year period to complete the adjustment to the applicable standards.
4. Handling of Applications under Review
Applications that were submitted before the notification took effect but have not yet completed review will be processed under the new notification. The competent authority may require applicants to submit additional documents or supporting materials.
2. The 21 Medical Device Categories and Their Applicable Standards
According to the annex to the notification, the products involved in this update can be grouped as follows.
(1) Common Medical Devices and Consumables
| No. | Product | Applicable Standard Basis |
|---|---|---|
| 1 | Surgical gloves | Notification on surgical gloves in Thailand |
| 2 | Contact lenses | Notification on contact lenses in Thailand |
| 3 | Single-use sterile insulin syringes | Notification on insulin syringes |
| 4 | Single-use sterile hypodermic syringes | Notification on hypodermic syringes |
| 5 | Medical examination gloves | Notification on medical examination gloves |
| 6 | Condoms | Notification on condoms |
| 7 | Viscoelastic products for use in surgery | Notification on viscoelastic products for use in surgery |
| 8 | Urine methamphetamine test reagents | Notification on urine methamphetamine test reagents |
(2) Blood, In Vitro Diagnostic, and Other Products
| No. | Product | Applicable Standard Basis |
|---|---|---|
| 9 | Human blood collection bags | Notification on blood collection bags |
| 10 | Hemodialysis concentrates | Notification on hemodialysis concentrates |
| 11 | Teeth whitening products | Notification on teeth whitening products |
| 12 | HIV infection test reagents | Notification on HIV test reagents |
| 13 | HIV self-test reagents | Notification on HIV self-test products |
| 14 | Contact lens care products | Notification on contact lens care products |
| 15 | Injectable hyaluronic acid products | Notification on injectable hyaluronic acid for correcting skin defects |
| 16 | Alcohol-based disinfection products | Notification on disinfection products for use on humans, animals, and medical devices |
| 17 | Silicone breast implants | Notification on silicone breast implants |
(3) Medical Protective Products
Items 18-21 are among the most notable contents of this annex: the notification not only defines the product scope but also lists the corresponding technical standards.
| No. | Product | Applicable Standards |
|---|---|---|
| 18 | Surgical Gown / Isolation Gown | ANSI/AAMI PB70, EN 13795-1, YY/T 0506.2, etc. |
| 19 | Medical Coverall | ANSI/AAMI PB70, EN 14126, GB 19082, etc. |
| 20 | Single-use medical masks | TIS 2424, ASTM F2100, EN 14683, YY 0469, etc. |
| 21 | N95 and higher-level protective masks | TIS 2480, TIS 3189, TIS 3190, NIOSH, EN 149, GB 19083, etc. |
Note that the standard bases for the 21 product categories are not all the same. Items 1-17 mainly refer to the product-specific standard notifications, while items 18-21 additionally specify concrete technical standards in the annex.
3. Focus: Standard Requirements for Medical Protective Products and Masks
The annex to this notification lists fairly specific technical standards for the products in items 18-21, which is of direct reference value for preparing registration dossiers and test reports for the relevant products.
1. Surgical Gowns and Isolation Gowns
The relevant products include:
- Surgical Gown
- Isolation Gown
The notification requires compliance with one of the following standards, or with equivalent standards that conform to the provisions of the notification:
| Standard | Standard Name and Main Focus |
|---|---|
| ANSI/AAMI PB70:2012 | Liquid barrier performance and classification of protective clothing and drapes intended for use in health care facilities |
| EN 13795-1:2019 | Performance requirements and test methods for surgical clothing and drapes |
| YY/T 0506.2-2016 | Performance requirements and test methods for surgical gowns, surgical drapes, and clean air suits |
For the above standards, the notification also addresses subsequent versions of the relevant performance requirements.
2. Medical Coveralls
The standards listed in the annex include:
| Standard | Main Technical Focus |
|---|---|
| ANSI/AAMI PB70:2012 | Liquid barrier performance |
| EN 14126:2003 | Performance requirements and test methods for protective clothing against infective agents |
| GB 19082-2009 | Technical requirements for single-use medical protective clothing |
Among these, the main performance indicators covered by GB 19082-2009 include:
- Liquid barrier performance;
- Filtration efficiency;
- Flammability resistance;
- Antistatic performance;
- Electrostatic charge decay performance;
- Skin irritation.
When preparing the relevant technical documents, companies should combine the actual product with the standards adopted to confirm whether the test items cover the corresponding requirements.
3. Single-Use Medical Masks
The standards listed in the annex include:
| Standard | Standard Name |
|---|---|
| TIS 2424-2562 | Thai Industrial Standard for single-use medical masks |
| ASTM F2100-25 | Standard for performance of materials used in medical face masks |
| EN 14683:2025 | Medical face masks – requirements and test methods |
| YY 0469-2023 | Surgical masks for medical use |
The notification also allows the use of other equivalent standards that meet the requirements. ASTM F2100-25 and EN 14683:2025 are the versions explicitly listed in this annex, and companies should verify the standard versions on which their existing test reports are based.
4. N95 and Higher-Level Protective Masks
For medical protective masks at N95 level and above, the notification lists fairly detailed standards and test bases.
(1) Thai Industrial Standards
| Standard | Corresponding Level |
|---|---|
| TIS 2480-2562 | N95 |
| TIS 3189-2564 | N99 |
| TIS 3190-2564 | N100 |
(2) NIOSH Test Requirements
The notification references the test methods related to NIOSH 42 CFR Part 84, mainly including:
- 84.174: filtration efficiency testing for non-powered N-, R-, and P-series filters;
- 84.172: airflow resistance testing.
Among these, the notification states that for the differential pressure (Delta-P) test, the airflow resistance test results specified in Section 84.172 of NIOSH 42 CFR Part 84 may be used as an alternative.
(3) Other International Standards
| Standard | Main Technical Requirements |
|---|---|
| EN 149:2001+A1:2009 | Filtering half masks against particles: performance, total inward leakage, penetration of filter material, skin compatibility, flammability, breathing resistance, etc. |
| EN 14683:2019+AC:2019 | Splash resistance and bacterial filtration efficiency (BFE) of medical face masks |
| GB 19083-2010 | Filtration efficiency, airflow resistance, synthetic blood penetration, surface resistance to wetting, flammability, and skin irritation of medical protective masks |
The notification also references the FDA guidance document ‘Surgical Masks – Premarket Notification [510(k)] Submissions’, which covers liquid barrier performance, particulate filtration efficiency, bacterial filtration efficiency, differential pressure testing, and flammability testing.
For protective masks at N95 level and above, manufacturers should confirm, based on the actual product level and applicable standards, whether the corresponding test reports and technical indicators satisfy the requirements of the notification.
4. Transitional Arrangements for Registered Products and Applications under Review
In addition to updating the list of product standards, this notification specifies how products in different statuses will be handled. This part is particularly important for companies that have already obtained Thai registration licenses as well as those currently going through registration.
1. Licensed or Registered Products: One-Year Transition Period
Under Article 5 of the notification: for manufacturers and importers that had already obtained licenses, completed detailed submissions, or completed the relevant product notifications before the notification took effect, if they wish to continue the relevant manufacturing or import activities, they must comply with the corresponding standards under the new notification within one year from the effective date of the notification.
In other words, companies are not required to complete all adjustments immediately on November 3, 2026, but must complete the standards conformity work within the specified transition period.
2. Products Already on the Market: Sales Arrangements
The notification also provides: sellers may continue to sell their relevant medical devices until the product validity period expires, or until the Secretary-General of the Thai FDA orders the suspension or cessation of sales.
Therefore, for products already legally on sale, it is necessary to distinguish between the standards conformity obligations of manufacturers and importers and the sales arrangements for existing products held by sellers.
3. Future Standard Revisions: Up to One Year to Adapt
Under Article 6 of the notification: if a medical device standard listed in the annex is subsequently revised or supplemented, a manufacturer or importer that has already carried out the relevant activities under the original standard before the new standard takes effect may continue to use the original standard after the new standard takes effect, for a period not exceeding one year.
This means that a standard update does not necessarily require companies to replace all technical documents and test reports on the day the new standard takes effect, but the transition must be completed within the specified period.
4. Applications under Review: Processed under the New Notification
Under Article 7 of the notification: applications for manufacturing or import licenses, or for detailed product submissions, that were submitted before the effective date of this notification and are still under review by the competent authority will be processed under this notification. In addition, the competent authority may require applicants to submit further documents or supporting materials.
5. Impact on Medical Device Manufacturers and Importers
First, check whether your products fall within the 21 categories listed in the annex.
Companies dealing in gloves, contact lenses, syringes, IVD test reagents, injectable hyaluronic acid products, and medical protective products should first confirm whether their products fall within the scope listed in the notification.
Second, re-verify the applicable standards and versions for your products.
For surgical gowns, isolation gowns, protective clothing, medical masks, and N95 masks, pay close attention to the standards and versions listed in the notification, and confirm whether existing test reports meet the corresponding requirements.
Third, review existing technical documents and test reports.
For products that have already obtained Thai licenses, review the existing product technical documents, test reports, and standards conformity evidence in light of the one-year transition period, and determine whether supplements or updates are needed.
Fourth, monitor registration projects under review.
For projects that have been submitted but not yet approved, assess the impact of the new notification on the submission materials and prepare to provide additional documents or supporting materials if required.
Official source: https://medical.fda.moph.go.th/relevant-laws-and-standards/mdlaw135336
Disclaimer: This article summarizes the Ministry of Public Health notification on medical device standards (B.E. 2569) published in the Royal Gazette on 2 November 2026. Requirements are subject to the official Thai text; this content is for information only and does not constitute legal or compliance advice.