Medical Product Labeling
Medical product labeling is an integral part of the control system and ensuring the safety of medical devices for patients and healthcare professionals. This process not only identifies medical devices and provides information about their use, but also guarantees compliance with quality, safety and efficacy requirements established by medical regulatory authorities. In this context, proper labeling becomes a key element in preventing erroneous use of medical devices and ensuring a high standard of patient care.
Dextra Law legal company specialists will greatly facilitate the process of bringing products to market and ensure compliance with all requirements and standards.
Requirements for labeling and accompanying documents for medical devices
In Ukraine, the requirements for labeling and accompanying documents for medical devices are regulated by legislation and state healthcare oversight bodies. The main requirements include:
- Manufacturer and representative identification. Pharmaceutical product labeling must contain the full name and address of the manufacturer of the medical device, as well as information about the authorized representative (if applicable).
- Classification and purpose.
- Certification confirming compliance with standards and requirements.
- Information on safety measures and recommendations for using the medical device.
- Shelf life.
- Instructions for use and storage rules.
- Warnings and restrictions associated with the use of the medical device.
- Serial number.
- Barcodes and QR codes for quick identification.
Information that should be on the packaging of drugs, dietary supplements, medical devices and any other types of products
The packaging of a drug, dietary supplement, medical device must contain the following information:
- Full and accurate product name to identify its purpose.
- Name and address of the manufacturing company, as well as contact information.
- Compliance with standards and regulations must be confirmed by relevant certificates indicated on the packaging.
- Date until which the product remains suitable for use.
- Unique number to identify the product batch.
- Details on how to properly use the product, including dosage and recommendations.
- Information about possible side effects, warnings and restrictions on the use of the product.
- List of active and auxiliary components of the product.
- Product storage conditions to ensure its quality.
- Some products may contain barcodes or QR codes for quick identification and traceability.
- If the product complies with certain standards, these standards may be indicated on the packaging.
- In the case of drugs and medical devices, the registration or license number may be required.
What are the fines for violations, and what are the consequences
Fines for violating the requirements for labeling of medical devices:
- Monetary fines. The amount of the fine may vary from relatively small amounts to significant sanctions, especially if the violation concerns patient safety.
- Confiscation of products. Violation of labeling can lead to the entire batch of goods being seized and destroyed.
- Product recall. Regulatory authorities may order the manufacturer to recall the product from the market if serious violations are detected.
- Civil liability. If non-compliance with the requirements for labeling of drugs or devices causes harm to patients or other parties, the manufacturer may be sued for damages.
- Loss of license or registration. Serious violation of labeling requirements may result in loss of license or registration for the manufacture and sale of medical devices.
Benefits of working with Dextralaw
Every client who has decided to use the legal services of Dextralaw is guaranteed the following advantages:
- experience and competence;
- individual approach;
- information support;
- minimizing the risk of violations and discrepancies