A new regulation was issued by the Minister of Health on 18 July 2025, establishing the criteria for medical devices that may be sold in the retail market. The criteria are as follows:
- The product holds a valid Distribution License Number (Nomor Izin Edar/NIE)
- Classified as a low-risk medical device
- Suitable for use outside of healthcare facilities
- Low potential for misuse
- The benefits outweigh the risks
- Does not require medical expertise to operate
To view the full regulation and the list of permitted medical equipment, please refer to the attached document:
(provided in Indonesian; English translation is not available)
In addition, business operators must ensure that their facilities comply with applicable regulations in Indonesia and that they only source products from licensed medical device manufacturers and distributors.
The appendix of the regulation includes examples of products that may be sold in the retail market, such as:
- Hot or cold compresses
- Manual and electric toothbrushes
- Dental floss
- Manual and electric breast pumps
- Sterile and non-sterile medical adhesive tape and bandages
- Nipple shields
- Teething rings
- Water-filled teething rings
- Condoms and condom lubricants
- Medical masks
- Sanitary pads
- Pantyliners
- Adult diapers
- Nasal irrigator
- Thermometer
- Pregnancy test kit (strips, midstream, and card)
- Stand-on patient scale
- Gloves
- Oximeter
- Digital blood pressure monitor
- Glucometer (glucose/blood sugar test kit (strips))
- Steam inhaler (Empty inhaler without medication)
- Alcohol swab
- Walking aid
- Nebulizer
- Non-prescription hearing aid
Effectivity
This decree is effective immediately as of its issuance date.
Issued Date:
July 18, 2025
Implications to Clients
Clients who wish to sell their products in the retail market must ensure compliance with the criteria outlined in the regulation. This includes offering only approved low-risk products, ensuring all items have a valid Distribution License Number (NIE), and sourcing exclusively from licensed manufacturers and distributors. Compliance with these requirements is essential to avoid regulatory issues and ensure smooth market operations.
For more information or assistance, contact us at sales@andamanmed.com or click the button below.
