PPMSE Guidelines for Medical and Household Health Supplies
On November 24, 2019, the Indonesian government issued Government Regulation No. 80 of 2019 concerning Electronic System Trading (PP PMSE). This regulation addresses crucial aspects of e-commerce in Indonesia, provides a legal framework for electronic trading, and ensures that products sold online meet established standards. Specifically for medical devices, this regulation requires a registration number or notification number from the Ministry of Health as proof that the products meet the prescribed safety and quality standards. This ensures that consumers can have greater confidence in the safety and authenticity of medical products purchased online.
The criteria for medical device products that can be distributed through PPMSE are as follows:
- The product can be used independently by the general public (without professional assistance) and does not require special skills. Examples include: body scales, menstrual pads, and toothbrushes.
- The product does not pose a high risk due to its use. Examples include: massage chairs and heating pads.
- The product does not pose a high risk due to misinterpretation of test results. Examples include: pregnancy test strips and rapid blood glucose meters.
- Optical medical device products can be distributed through electronic systems with the following criteria:
- Can be used independently without the help of healthcare professionals.
- Does not require invasive procedures for use.
- Does not require advanced technology for use and interpretation.
- Does not require healthcare professionals to interpret the results..
List of medical devices that can be distributed through PPMSE electronic systems includes:
- In vitro diagnostic self-testing devices such as cholesterol meters, blood glucose meters, and uric acid meters.
- Home use medical devices
- Electric massage devices/therapeutic massagers
- Hot/cold compresses
- Heating pads
- Cane pads, canes, walkers, and mechanical walkers
- Bedpans
- Dental floss and floss picks
- Cold packs/compress plasters
- Continuous positive airway pressure (CPAP)
- Neck braces
- Flotation cushions
- Hand carriers
- Hernia supports
- Hot or cold disposable packs
- Medical insoles
- Glasses and lenses
- Ice compress bags
- Gauze, gauze dressings, and medical sponges
- Condoms
- Contact lenses
- Manual wheelchairs
- Limb orthoses/arm supports
- Lubricants
- Medical masks
- Menstrual cups
- Moist heat packs
- Post-operative eye protectors
- Nipple protectors
- Menstrual pads
- Denture cleaners
- Contact lens cleaners
- Tongue cleaners
- Blood pressure monitors
- Elastic bandages
- Bedpans
- Medical adhesive tape and bandages
- Plasters and wound dressings
- Manual and electric breast pumps
- Adult diapers
- Pulse oximeters
- Toothbrushes and electric toothbrushes
- Galvanic spa devices
- Pregnancy test strips/test packs
- Tampons
- Hand-carried stretchers
- Teethers
- Teething rings
- Manual beds
- Disposable medical beds
- Thermometers
- Infusion poles
- Body scales
- Truncal orthoses
Reference:
Guidelines for the Circulation of Medical Devices and Household Health Supplies through Electronic Systems