CFDA Updates 20170313-20170317

Clinical Evaluation Reports or Clinical Trials?
March 24, 2017
CFDA Updates 2017.03.22-2017.03.24
April 12, 2017

CFDA Updates 20170313-20170317

7 new guidelines have been released by CFDA from March 13rd to March 17th. 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. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com

1.   On March 16th, CFDA issued a technical review guideline on visible spectrum therapeutic equipment. 

It is class II with class code 6826 or 6824.

This guideline applies to visible spectrum therapeutic equipment and weak laser therapeutic instrument. The visible spectrum therapeutic equipment is used in physical therapy and rehabilitation equipment. It is class II with class code 6826. Weak laser therapeutic instrument is used in medical laser equipment. It is class II with class code 6824. This guideline is aimed at guiding and standardizing the documents preparation of Class II visible spectrum therapy instrument products. It also provides a reference for technical review department to review the registration documents for CFDA approval

2.    On March 16th, CFDA issued a technical review guideline on flexible fiberscope. 

It is class II with class code 6822.

This guideline applies to diagnostic fiberscope product, such as upper gastrointestinal endoscope, fiber colonoscope, fiber bronchoscope, fiber laryngoscope, fiber choledochoscope, fiber cystoscope. Other Class II fiber endoscope may refer to this guideline. 

3.    On March 16th, CFDA issued a technical review guideline on rigid endoscope.

It is class II with class code 6822.

The guidline is applicable to Class II rigid endoscope products, such as laryngoscope, nasal endoscope, urethral cystoscope, hysteroscope. Other Class rigid endoscopies may refer to this guideline. 

4.    On March 16th, CFDA issued a technical review guideline on syringe pump. 

It is class II with class code 6854.

Syringe pump products use one or more single action injector or similar container to control the infusion liquid flow. The speed of the infusion is set by the operator and is indicated by the equipment. This guideline doesn’t refer to other “syringe pump” that is not defined in GB 9760.27-2005 standard, including all types of infusion pumps, infusion controller products and target injection pump products.

5.    On March 16th, CFDA issued a technical review guideline on surgical electrodes.

 It is class II with class code 6825.

This guideline applies to surgical electrodes which connect to a high frequency generator and intended use only in open surgery. The electrodes can be divided into monopolar electrode, bipolar electrode and neutral electrode.

6.    On March 16th, CFDA issued   a technical review guideline on medical electronic thermometer.

It is class II with class code 6820.

This guideline applies to medical electronic thermometer products which would intermittently monitor body temperature by direct contact to patients. The measuring body parts include mouth, armpit or anus, etc. It does not refer to indirect thermometers such as infrared thermometers, continuous body temperature measurement equipment and other equipment with temperature measuring function. However, it can be a reference to these indirect thermometers.

7.    On March 16th, CFDA issued a technical review guideline on diode laser therapy instrument. 

It is class II with class code 6824.

This guideline applies to diode laser therapy instrument with the wavelength of 650 or 635nm.  

About China Med Device, LLC (CMD)

CMD provides turn-key solution for U.S. medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth, by offering: market Intelligence and research; clinical study and trial design management; distribution qualification and management; partnership and strategic funding guidance.

FREE Situational Review: Are you exploring entry into China? Let us help you develop an approach that optimizes your efforts. Email us info@ChinaMedDevice.com and check out additional resources on our website: www.ChinaMedDevice.com.