NMPA issued nine guidelines in September. The guidelines cover indications of orthopedic, cardiovascular, hematology, general hospital, etc.

General

• Technical guideline on medical device cybersecurity (draft)
• Technical guideline on verification of virus inactivation process for allogeneic implantable medical devices

Orthopedic

• Technical review guideline on evaluation of fatigue test of biological femoral stem
• Registration guideline on 3D printed patient-customized mandibular prosthesis
• Technical guideline on personalized matching bone implants and tools medical-industrial interactive quality control

General Hospital

• Technical review guideline on requirements and evaluation of needle stick protection devices for infusion products
• Registration guideline on disposable injection pen needle (draft)

Cardiovascular

• Registration guideline on balloon dilatation catheter

Hematology

• Clinical evaluation guideline on ultrasonic soft tissue cutting hemostasis system (draft)

For an English version of any guideline above, please email us at info@ChinaMedDevice.com. We can also help you deliver opinions to the NMPA for the draft guidelines.

What are the Implications

Whether you are renewing or submitting new registration, your medical devices and IVDs need to meet these new guidelines. Even if your renewals (every five years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new guidelines. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new regulation.

China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time. info@ChinaMedDevice.com.