Symbols on Medical Devices and Household Health Supplies

SymbolDescription
ManufacturerThis Medical Device Symbols must be displayed alongside the name and address of the manufacturer, positioned next to the symbol
Authorized representative in the European UnionThis Medical Device symbol is accompanied by the name and address of the authorized representative.
Date of manufactureThis Medical Device Symbols shall be accompanied by a date to indicate the date of manufacture.
Use-by dateThis Medical Device Symbols shall be accompanied by a date to indicate that the medical device should not be used after the end of the year, month or day shown.
Batch codeThis Medical Device Symbols shall be accompanied by the manufacturer’s batch code
Catalogue NumberThe manufacturer’s catalogue number shall be adjacent to the symbol.
Serial numberThis symbol shall be accompanied by the manufacturer’s serial number.
SterileIndicates a medical device that has been subjected to a sterilization process.
Sterilized using aseptic processing techniquesIndicates a medical device that has been manufactured using accepted aseptic techniques.
Sterilized using ethylene oxideIndicates a medical device that has been sterilized using ethylene oxide.
Sterilized using irradiationIndicates a medical device that has been sterilized using irradiation.
Sterilized using steam or dry heatIndicates a medical device that has been sterilized using steam or dry heat.
Do not resterilizeIndicates a medical device that is not to be resterilized.
Non-sterileIndicates a medical device that has not been subjected to a sterilization process
Do not use if the packaging is damagedIndicates that medical devices should not be used if the packaging is damaged or open
Sterile fluid pathIndicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.

Symbols on Medical Devices and Household Health Supplies (PKRT) play a crucial role in conveying essential information about their use, risks, and purpose to users. These internationally recognized symbols, mandated by regulatory bodies such as the EU and US FDA, are typically included on labels to denote details like manufacturing date, expiry date, and safety warnings. They help healthcare professionals, patients, and caregivers quickly understand important information, even across language barriers. To ensure clarity, explanations for new or unclear symbols must be provided, often in accompanying manuals or leaflets. Adopting standardized symbols enhances user comprehension, promotes safety, and ensures compliance with regulations, thereby contributing to improved patient outcomes and demonstrating the manufacturer’s commitment to user safety and satisfaction.


For further details, you can access the guidelines at the following link: https://regalkes.kemkes.go.id/informasi_alkes/008.%20Pedoman%20Penandaan%20ALKES.pdf, specifically pages 31-36.

Contact Us

We’re here to help! Feel free to reach out and schedule your free consultation today

Address

Wisma PMI 6th Floor Jl. Wijaya I No.63, RT.8/RW.1, Petogogan, Kec. Kby. Baru, Kota Jakarta Selatan, Daerah Khusus Ibukota Jakarta 12160

Phone

(021) 7279 3812

Whatsapp

+62 897 6470 070

Mail Address

marketing@insightof.co.id

Working Hours

Mon to Fri : 08:00 AM – 17:00 PM

Achieve regulatory success with INSIGHTOF

With our extensive experience in Indonesia’s regulatory environment, we provide the support you need to secure BPOM and Kemenkes approvals efficiently. Contact us today!