4 new guidelines have been released by CFDA from February 25th to March 3rd. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review phase or new submissions. If you need any detailed information regarding these guidelines and how they impact your devices in China, please contact us at firstname.lastname@example.org.
1. On February 28, CFDA issued a technical review guideline on Electrical Hospital Bed.
It is class II with class code 6856.
Electrical Hospital Bed is a bed specially designed for patients or others in need of some sort of health care. It has surface, bed frame, driving part, control part and accessories.
The purpose of this guideline is to guide and standardize the technical review of electrical hospital beds. It aims to help the CFDA reviewers to understand the principle, structure, performance and intended use of this product. So they can make systematic evaluation of product safety and effectiveness.
2. On February 28, CFDA issued a technical review guideline on Laparoscopic Instrument.
It is class II with class code 6822.
This guideline applies to reusable laparoscopic instruments, does not include flexible gastrointestinal endoscope disposable laparoscopic instruments. A laparoscopy operation is performed in the abdomen or pelvis through small incisions (usually 0.5–1.5 cm) with the aid of a camera. Laparoscopic instruments can either be used to inspect and diagnose a condition or to perform surgery.
3. On February 28, CFDA issued a technical review guideline on Surgical Shadowless Light.
It is class II with class code 6854-13.1.
Surgical shadowless light provides visual lighting on surgical vision or patients during surgery. It can be classified into fixed and mobile types according to the installation method. Besides, they can be classified into reflection lamp and refraction lamp based on optical principle. Moreover, they can be classified into halogen light, xenon light and LED light according to the type of light source. This guideline does not apply to surgical lighting lamp, surgical reflector light and diagnostic lighting lamp.
4. On March 3rd, CFDA issued a technical review guideline on Cochlear Implant System.
Cochlear implant is class III with class code 6846. Sound processor is class II with class code 6821. Cochlea adjusting device and debugging software is class II with class code 6870.
This guideline applies to cochlear implant system which used in the reconstruction of auditory for patients with severe deafness, including cochlear implants, sound processors and cochlea adjusting device and debugging software.