Qualtech recently held its Medical Device Compliance Update Series 2025 webinar, highlighting the latest regulatory developments across Indonesia, Thailand, and Vietnam. The session was led by Qualtech’s regional experts. Each sharing insights on recent policy changes and their practical implications for manufacturers, distributors, and importers.

 

Indonesia Regulation Updates

Between May and September 2025, Indonesia introduced several significant changes under the Ministry of Health and related authorities:

1. Retail Sale Authorization

• A new decree (KMK HK.01.07/MENKES/736/2025) now permits certain low-risk medical devices (such as thermometers, oximeters, masks, breast pumps, and pregnancy test kits) to be sold in hypermarkets, supermarkets, minimarkets, and retail outlets.
• While retailers are exempt from holding a medical device store permit (IDA), they must source products only from authorized distributors (with IDAK and valid licenses).
   

2. Procurement Reform

• E-Katalog Version 6 officially active starting October 1, 2025 — all government procurements above IDR 50 million must use this electronic procurement system.
• Local product prioritization: domestic devices with TKDN + BMP ≥ 40% favored in tenders.
   

3. Halal Certification Enforcement

• From July 2025, all halal-certified foreign products must be registered with BPJPH, while uncertified ones must declare their materials and comply before full enforcement.
• The latest Indonesian halal label must be used by October 17, 2026, and devices containing animal-derived or alcohol-based ingredients fall under the Halal Fatwa No. 01/2024 scope.
• Halal implementation timeline:

MD Risk Classification	Targeted Year
Class A	2026
Class B	2029
Class C	2034
Class D & Biological Products	2039

 

Thailand Regulation Updates

The Thai FDA has focused on efficiency and risk-based regulation through several new initiatives:

1. Positive List and Priority Track

A new “Positive List” now identifies Class 1 devices eligible for faster review, while a “Priority Track” benefits devices addressing Non-Communicable Diseases (NCDs) such as heart disease, diabetes, and cancer.
This allows eligible devices like glucose meters, ECGs, and blood pressure monitors to enjoy reduced registration times.

2. Regulatory Pathways

• Thailand continues with its three registration pathways:
  • Full Evaluation – Complete dossier and specialist review (up to 1.5 years)
  • HSA Reliance – Based on Singapore HSA approval (faster)
  • Abridge Route – For products approved in GHTF countries (exempting technical and preclinical documentation)
• These reliance pathways now cut review time by up to 40%, with Abridge being the most efficient.
   

3. Refer & Transfer

• Thai FDA allows companies to:
  • Refer – register a new brand name using an existing approved dossier from the same manufacturer and product owner.
  • Transfer – change the registered license holder/importer (e.g., Importer A to B) using identical dossiers.
• These processes simplify administrative changes without full re-registration.
   

4. Renewal

• For Full-CSDT submissions, no additional documents are needed, certificates are automatically renewed for 5 years.
• For Partial 1 & 2, renewal depends on post-market safety. If no issues occur, only a Safety Declaration Form is required; otherwise, supporting documents must be submitted.
   

5. Advertising

Advertising permit exemptions for academic exhibitions and medical conferences (with prior Thai FDA notice).

 

Vietnam Regulation Updates

Vietnam continues to streamline medical device approvals under Decree No. 98/2021/ND-CP, with new revisions expected soon.

1. Registration Routes

• For Class A & B devices, applications are submitted to the Department of Health via the IMDA system.
• For Class C & D, devices holding prior approvals (CFS/MA) from reference agencies qualify for a Fast Route (10 days), while others undergo a Standard Route (40–45 days).
   

2. Reduced Fees

Under Circular 64/2025/TT-BTC, appraisal fees for new registrations are cut by 50% to support enterprises and encourage faster market entry.

 

Key Takeaways

• ✔ Indonesia is broadening public access to medical devices while tightening procurement transparency and halal compliance.
• ✔ Thailand is prioritizing innovation and speed through reliance routes and priority tracks.

✔ Vietnam is modernizing its system to favor quicker registrations and lower costs.

The 2025 Southeast Asia medical device landscape reflects a strong push toward digitalization, local manufacturing, and regulatory reliance. As each country strengthens its own framework, regional cooperation and reliance pathways are becoming crucial for timely market access.

For global manufacturers aiming to expand across ASEAN, strategic regulatory planning and local expertise remain the keys to success — and Qualtech continues to be a trusted partner in navigating these evolving markets.

Contact us today to learn how we can help you streamline your registration process and accelerate your success in the ASEAN market.