Chinese market regulators propose guidance for 3D printed medical devices

The China Food and Drug Administration (CFDA) has published new guidance into the registration requirements for 3D printed medical devices.

The draft guidance is intended to address industry questions into how the CFDA will approach the regulation for 3D-printed medical devices on the Chinese market.

The guidance covers 3D-printed implantable devices for orthopaedic and dental applications; biomaterials and pharmaceuticals produced using additive manufacturing.

The CFDA will also require validation testing for 3D printing manufacturing equipment and processes, as well as materials, software and final products.

Other key proposals of the guidance include environmental parameters which should include temperature, pressure, humidity, gas composition, printing speed, energy density and related factors.

The guidance also proposes that Product validations should include usability tests, that clinicians and healthcare professionals be involved in the design of 3D printed devices and that the use of 3D-printed medical implants should involve contracts between patients, manufacturers and healthcare providers.

It also states that additive manufacturers must conduct cleaning processes which may not be outsourced given the complexity of 3D printed medical devices.

The CFDA is awaiting comments from the industry and is aiming to issue a final version of the guidance to address the 3D printing sector.

Dikale 3D Print Removal Tools with Sturdy Wooden Handle, Tool Kit for 3D Printer Spatula Palette Knife Painting Enhanced Version Pack of 2

Dikale 3D Print Removal Tools

Product Features

  • ✔️【Enhanced version pack of 2】It includes 2 sizes. You can choose a suitable one to help with prying out printed items.
  • ✔️【Thicker neck,not bent easily】It needs to be just a bit stiffer to loosen a stubborn print, but it doesn’t damaged any of your projects your my printer bed by using it.
  • ✔️【Fantastic and versatile】Although it’s marketed as a 3D print removal tool, it also very useful for removing stickers and scraping the small amounts of filament you tend to get stuck on the bed from not having a level bed, and it helped remove the painters tape residue left from the tape. Works very well to remove freshly printed parts.
  • ✔️【Flexible and effective】This 3D Print Removal Tool works super well. A must have for a 3D printer. It’s great for getting prints off your print surface without damaging their bases. It is very simple and extremely effective. Seems to be very well constructed and the blade is flexible but doesn’t get bent up easily; it has a very flat top which makes removing models really easy.
  • ✔️【Durable and stiff】Note that this isn’t made for prying the print off the bed like you would use a putty knife. It’s more for sliding under the print and unsticking as you go, or perhaps slipping the middle under the print and “sawing” the print off. It’s thin and flimsy which lets it get under the print, but not TOO flimsy – it’s also thick enough to be durable, assuming you aren’t prying. Prying would definitely ruin this tool. This tool is that much better than trying to use something else.

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Creality MK10 Assembled Extruder Hot End Kit for CR-10 CR-10S S4 S5 3D Printer with Aluminum Heating Block, 1.75mm, 0.4mm Nozzle


– Installation type: External thread connection
– Application: Creality 3D printers CR-10 CR-10S S4 S5
– Nozzle size: 0.4mm
– Cable length: 1.2m
– Heating Tube: 12V 40W
– Operating temperature range: -40~+260°C (-40~+500°F)
– Material: Aluminum+Stainless Steel+Brass
– Throat length: 52mm
– Aluminum block size: approx. 20 x 20 x 10mm


1 x Aluminum Block
1 x Heating Tube
1 x M6*30mm Throat Pipe (Built-in Teflon)
1 x Thermistor +Brass Sleeve
1x 1.75mm 0.4mm Brass Nozzle

Please note:

Due to light and screen difference, the color may be slightly different from the pictures.
Please allow 1-5mm deviation due to manual measurement.

Product Features

  • 100% original and high quality 3D Printer accessories for Creality CR-10 CR-10S S4 S5
  • Work with different sizes of MK8 nozzle: 0.2mm 0.3mm 0.4mm 0.5mm 0.6mm 0.8mm 1.0mm nozzle
  • MK8 Extruder Hot End Kit, white wire is temperature thermistor, red wire is heating tube 12V 40W
  • Tip of the nozzle, aluminum heating block, throat pipe (built-in Teflon)
  • CHPOWER is a TRUSTED VENDOR, we provide 12-month manufacturer warranty on all parts. Buy with confidence.

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3D PLA-0.5KG1.75-PNK PLA 3D Printer Filament, Dimensional Accuracy +/- 0.05 mm, 0.5 kg Spool, 1.75 mm,Pink Silk feeling Printing Material

Diameter (Tolerance): 1.75 mm ±0.05 mm Net Weight: 500g Recommended Printing Temp: 195 – 230 °C Recommended Printing Speed: 30 – 90 mm/s Heated Bed: ~ 80 °C “” “

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