The Regulations on Medical Device Laser Marking

The laser marking of the three types of medical devices must conform to stringent regulations, including requirements for the clarity of the UDI code and the suitability of materials.When choosing a professional medical-grade tattooing machine, one must pay special attention to certification, and a standard process must be established for adjusting the parameters based on the material being used.Regulated laser markings are not only a requirement of regulations, they are also an important safeguard for the safety of patients.

Basic knowledge about medical laser tattoo removal.

Nowadays, laser marking machines can be seen in many medical device production lines, especially in the production of high-risk Class 3 medical devices, such as heart stents and artificial joints. The marking of these devices is absolutely not something to be taken lightly.The laser marking technology can not only make permanent marks, but it also doesn't damage the surface of the device. This non-contact manufacturing process is particularly suited to the medical industry.

The standards for each of the three categories of equipment.

A look at the key points of the new regulations.

According to the National Medical Products Administration's (NMPA) latest regulations on the unique identification system for medical devices, the labels of Class Ⅲ medical devices must include core information such as UDI codes, production batch numbers, and expiration dates.The smallest height of these characters cannot be less than 0.5mm, and they must maintain their color for at least 10 years, since some devices will remain in the body for many years.

Materials adaptability test.

Different materials require different parameters for laser marking.In one case we encountered, a manufacturer's bone screws developed micro-cracks after being marked due to improper parameter settings, and the entire batch of products had to be scrapped.

Precision control.

The recognition rate of QR codes and bar codes must reach 100 %, which is not as easy as the bar code scanning in a supermarket.In particular, the marking of minimally invasive surgical instruments often needs to be completed in a circle with a diameter of just 2 mm, which places extremely high demands on the focusing precision of the equipment.

Advice on equipment selection and production.

Look at the credentials carefully.

When buying equipment, remember to check for three certificates: a quality management system certificate for medical equipment, a laser safety certificate, and most importantly a medical equipment registration certificate.Last year, a company bought some non-medical-grade equipment in order to save money, but the FDA discovered the problem and forced the company to halt production.

Small tricks for parameter tuning.

Different materials require different parameters. For example, the power required to mark cobalt-chromium alloy is 20 % higher than that required to mark pure titanium.I suggested that they do some destructive testing on scrap material before they start production, to calibrate the energy parameters to the point at which they can get a clear mark without damaging the material.