CFDA has issued 7 new guidelines from September 13rd to September 21st. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com.
On September 21st, CFDA issued 4 technical review guidelines for comments:
1. Rigid optical endoscope (invasive) registration technical review guideline (draft)
Classification: Class III
Class Code: 06-14 (New classification catalog)
This guideline applies to Class III rigid optical endoscope that enter the human body primarily through invasive procedure instead of human body natural cavity or channels. The following are examples of endoscopes with invasive procedures: abdominal endoscope, arthroscope, intervertebral disc endoscope, thoracic endoscope etc.
2. Ultrasonic soft tissue cutting and hemostatic scalpel registration technical review guideline (draft)
Classification: Class III
Class Code: 01-01
This guideline applies to ultrasonic soft tissue cutting and hemostatic scalpel product that can be used for soft tissue cutting and vessel closure. Special requirements of more than 3mm vessel cutting and closure is not included.
3. Ophthalmic ultrasound diagnostic equipment registration technical review guideline (draft)
Classification: Class III
Class Code: 16-04
This guideline applies to ophthalmic A-type ultrasonic measuring instrument and ophthalmic B-type ultrasound diagnostic instrument
4. Human epidermal growth factor receptor (EGFR) mutant gene detection reagents technical review guideline (draft)
The EGFR gene mutation detection reagent mentioned in this guideline is used for the in vitro qualitative detection of the target gene sequence in cytology samples, fresh tissue, frozen tissue and nucleic acid components extracted from other body fluids.
On September 13th, CFDA issued 3 technical review guidelines.
1. Infrared breast examination instrument registration technical review guideline
Classification: Class II
Class Code: 06-13
This guideline applies to infrared breast examination instrument which consists of probe, camera, host (with or without software), monitor and accessories.
2. Medical gynecological ozone therapeutic instrument registration technical review guideline
Classification: Class II
Class Code: 18-04
This guideline applies to medical gynecological ozone therapeutic instrument. It has 3 output modes: ozone water, ozone fog and ozone air.
3. Bone tissue surgical instruments registration technical review guideline.
Classification: Class II
Class Code: 04-12
This guideline applies to active surgical instruments used in orthopedic surgery.
About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------