Indonesia Expands Retail Access to Medical Devices

On 18 July 2025, Indonesia’s Ministry of Health issued “Ministerial Decree No. HK.01.07/MENKES/736/2025,” introducing a new framework that permits certain low-risk medical devices to be sold through general retail channels.

Under the new policy, eligible products may be distributed via hypermarkets, supermarkets, minimarkets, household goods wholesalers, and other non-specialized retail businesses. The measure represents a notable shift in Indonesia’s medical device distribution model, which has traditionally limited sales to pharmacies, healthcare facilities, and licensed medical outlets.

Policy Objectives

The decree was introduced to improve accessibility, availability, and affordability of basic medical devices for the general public. According to the Ministry of Health, the focus is on products that can be safely used at home without professional medical supervision.

By integrating selected medical devices into familiar retail environments, the Ministry aims to strengthen public access to essential health products while maintaining regulatory oversight of safety, quality, and supply chain integrity.

Medical Devices Permitted for Retail Sale

To provide clarity for market participants, the decree includes an official list of 26 medical devices approved for sale through retail businesses. These products are primarily low-risk, commonly used, and suitable for consumer self-administration.

Examples from the official list include:

1. Hot/cold compress packs
2. Manual and electric toothbrushes
3. Dental floss
4. Manual and electric breast pumps
5. Medical adhesive tapes & bandages (sterile/non-sterile)
6. Nipple shields
7. Teething rings (without liquid)
8. Teething rings (with liquid)
9. Condoms & lubricants
10. Medical face masks
11. Sanitary pads
12. Pantyliners
13. Adult diapers
14. Nasal irrigators
15. Thermometers
16. Pregnancy test kits
17. Stand-on patient scales
18. Gloves
19. Pulse oximeters
20. Digital blood pressure monitors
21. Blood glucose test strips
22. Empty steam inhalers
23. Alcohol swabs
24. Walking aids
25. Nebulizers
26. Non-prescription hearing aids

This list serves as a practical reference for manufacturers, distributors, and retailers assessing which products may enter mainstream consumer sales channels in Indonesia.

Eligibility Criteria for Retail-Distributed Medical Devices

In addition to the specified product list, the decree establishes six conditions that any medical device must meet to qualify for retail sale. These criteria are intended to ensure consumer safety and appropriate use outside clinical settings.

Retail-eligible medical devices must:

1. Hold a valid Indonesian Marketing Authorization Number (NIE)
2. Be classified as low-risk medical devices
3. Be suitable for use outside healthcare facilities
4. Present a low potential for misuse
5. Deliver greater public benefit than potential risk
6. Not require specialized medical skills for operation

Together, these requirements reinforce the Ministry’s emphasis on limiting retail distribution to consumer-friendly and low-risk products.

Compliance Requirements for Retailers

The decree also introduces clear compliance obligations for retail businesses intending to sell medical devices. These requirements focus on licensing, sourcing, and quality assurance across the retail supply chain.

Retailers must hold appropriate business licensing in accordance with Indonesia’s risk-based licensing system. In addition, sourcing restrictions apply based on the type of retail business:

• Household goods wholesalers may procure medical devices only from licensed manufacturers and licensed medical device distributors.
• Hypermarkets, supermarkets, minimarkets, and other retail stores may source devices from licensed manufacturers, licensed medical device distributors, or licensed household goods wholesalers.

Retailers are also responsible for maintaining product safety, quality, and compliance throughout storage and sale. This includes proper storage conditions, protection against damage or contamination, and appropriate display and handling practices.

Implications for the Medical Device Industry

Taken together, these changes signal a broader transformation in how low-risk medical devices reach Indonesian consumers. The policy creates new commercial opportunities while reinforcing regulatory accountability across the supply chain.

Opportunities and Responsibilities for Manufacturers and Importers

For manufacturers and overseas brand owners, the expansion of retail sales channels offers broader access to Indonesia’s consumer health market. Low-risk medical devices may increasingly be positioned as everyday health products rather than limited to professional or pharmacy-based distribution.

At the same time, manufacturers and importers should ensure that packaging, instructions for use, and labeling are suitable for consumer use and fully compliant with Indonesian regulatory requirements.

Operational Considerations for Distributors

Distributors may benefit from increased demand and a wider retail customer base as more outlets are permitted to sell medical devices. The framework also clarifies sourcing pathways, reinforcing the role of licensed distributors in maintaining supply chain integrity.

Distributors remain responsible for supplying only appropriately licensed retailers and for preserving product quality, traceability, and compliance throughout distribution activities.

Business Opportunities for Retailers

Retail businesses are now able to participate directly in Indonesia’s growing consumer medical device segment. This creates new revenue opportunities while establishing clear expectations around licensing, sourcing, storage, and product handling.

By adhering to these requirements, retailers can integrate medical devices into their product offerings with regulatory confidence.

Benefits for Consumers

For consumers, the policy improves access to affordable, low-risk medical devices through familiar retail environments. It supports greater convenience and self-care while maintaining safeguards around product safety and quality.

Strengthening Indonesia’s Medical Device Retail Framework

“Ministerial Decree No. HK.01.07/MENKES/736/2025” represents a meaningful regulatory development in Indonesia’s healthcare and retail sectors. By permitting selected low-risk medical devices to be sold through household goods wholesalers, supermarkets, and minimarkets, the Ministry of Health aims to enhance accessibility while safeguarding public health.

Compliance remains essential. Manufacturers, importers, distributors, and retailers must meet strict licensing, sourcing, and quality assurance requirements to participate in this expanded market. Partnering with experienced regulatory advisors can help ensure alignment with Indonesia’s evolving medical device framework.

For practical guidance on Indonesian market access and compliance strategy, contact Cisema today for dedicated regulatory support.

Further Information

Explore Cisema’s medical device registration services in Indonesia.