News Update - 0315~0321

Department

Update

Link

NMPA

Announcement of 26 Medical Device Industry Standards

Among them:

- "YY/T 2000-2026 Medical Device Real World Data: Terminology and Definitions"

- Implementation date: March 1, 2027

Link

CMDE

Registration Review Guidelines for X-ray Blood Irradiation Equipment

Link

CMDE

Recruitment enterprises and units for guidelines preparation:

- Patellar claw

- Skull clamp/lock

- Partial knee joint prosthesis

- Gingival exfoliation material

- Teeth bleaching products

- Dental abutment products

- Personalized abutment crown bridge

- Dental base polymer material

Link

CMDE

Priority application results announcement

- Product: Embryo Preimplantation Thalassemia Gene Detection Kit (Combined Probe Anchored Polymerase Sequencing Method)

- Company: Suikang Medical Technology (Suzhou) Co., Ltd.

Link

CMDE

Draft for Soliciting Opinions on Guidelines for Brain-Computer Interface Devices

- Guideline for Classification Definition of Medical Devices Utilizing Brain-Computer Interface Technology

- Guideline for Naming General Names of Medical Devices Utilizing Brain-Computer Interface Technology

Link