Expanding Access to Healthcare Products

In order to improve access and availability of healthcare products that are more equitable and affordable for the public, this decision has been made to designate certain types of healthcare products that can be sold by large-scale traders of household equipment and supplies, hypermarkets, supermarkets, minimarkets, and other retail traders.

 

Ministerial Decree on Retail Sale of Medical Devices

On July 18, 2025, the Minister of Health issued Decree No HK.01.07/MENKES/736/2025 established examples of medical devices that can be sold by businesses engaged in the wholesale trade of household appliances and equipment, hypermarkets, supermarkets, minimarkets, and other retail businesses.

 

Criteria for Eligible Medical Devices

The criteria for medical devices that may be sold by businesses are as follows:

1. Possess a distribution license number (NIE)
2. Low-risk medical devices
3. Can be used outside healthcare facilities
4. Low potential for misuse
5. The benefits of availability outweigh the risks; and
6. Do not require specific medical expertise

 

Compliance Requirements for Businesses

The businesses in question must have the necessary business licenses in accordance with applicable laws and regulations and must ensure the quality and safety of the medical devices they sell. Medical devices must be sourced only from manufacturers and distributors that have the necessary business licenses in accordance with applicable laws and regulations.

 

Example of Medical Device That Can Be Sold by Retail Business Operators

No.	Name of Medical Device
1	Hot or cold compresses
2	Manual and electric toothbrushes
3	Dental floss
4	Manual and electric breast pumps
5	Sterile/non-sterile medical adhesive tape and adhesive bandages
6	Nipple shields
7	Teething rings
8	Water-filled teething ring
9	Condoms and condom lubricant
10	Medical masks
11	Sanitary pads
12	Pantyliners
13	Adult diapers
14	Nasal irrigator
15	Thermometer
16	Pregnancy test kits (strip, midstream, and cards)
17	Stand-on patient scale
18	Gloves
19	Oximeter
20	Digital blood pressure monitor
21	Glucose meter (glucose/blood sugar test kit (strips))
22	Vapor inhaler (empty inhaler without medication)
23	Alcohol swabs
24	Walking aids
25	Nebulizer
26	Non-prescription hearing aids

 

How Qualtech Can Support Your Market Entry in Indonesia

With this new regulation opening up wider retail opportunities for medical devices in Indonesia, ensuring full compliance with licensing and regulatory requirements is crucial. Qualtech’s experienced team can assist you in navigating Indonesia’s regulatory framework, securing product registrations, and achieving market access efficiently and reliably.