On November 24, 2019, the Indonesian government issued Government Regulation No. 80 of 2019 concerning Electronic System Trading (PPMSE). This regulation addresses crucial aspects of e-commerce in Indonesia and provides a legal framework for electronic trading. Additionally, it ensures that products sold online meet established safety and quality standards.
Medical Device Requirements
For medical devices, this regulation requires a registration number or notification number from the Ministry of Health as proof that the products comply with safety and quality standards. As a result, consumers can have greater confidence in the safety and authenticity of medical products purchased online.
Criteria for Medical Devices
The criteria for medical device products that can be distributed through PPMSE are as follows:
- User Independence: The product can be used independently by the general public without professional assistance. Examples include body scales, menstrual pads, and toothbrushes.
- Risk Assessment: The product does not pose a high risk due to its use. For instance, massage chairs and heating pads fall into this category.
- Misinterpretation: The product does not pose a high risk due to misinterpretation of test results. Pregnancy test strips and rapid blood glucose meters are examples.
- Optical Medical Devices: These can be distributed through electronic systems if they meet specific criteria:
- Can be used independently without the help of healthcare professionals.
- Do not require invasive procedures for use.
- Do not require advanced technology for use and interpretation.
- Do not need healthcare professionals to interpret the results.
List of Distributable Medical Devices
The following medical devices can be distributed through PPMSE electronic systems:
Disposable medical beds
In Vitro Diagnostic Self-Testing Devices: 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) devices
- 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
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