2 new guidelines have been released by CFDA on August 9th. 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 August 9th, CFDA issued a technical review guideline on Dental Implant Equipment.
It is Class II with the class code 6855.
This guideline applies to electronic dental implant equipment. The dental implant equipment is a medical electronic device that provides the power & force in dental implant surgery.
Dental implant equipment can be divided in to 3 categories based on their different structures: Build-in, net power supply and internal power supply.
(1) Summary Materials
a. The diagram and actual product picture that can describe the structure and principle of dental implant machine.
b. Provide technical specifications (technical standards); Any differences from the standards must be pointed out and explained.
c. Applicants should specify each component.
d. Applicants should explain the whole equipment configuration.
(2) Research Materials
a. Biocompatibility research materials
b. Sterilization process research materials
(3) Registration Unit Division
a. Build-in, net power supply and internal power supply dental implant machine should be divided into different registration units
b. Water supply piping, implantation surgical device should not be included in dental implant machine registration unit.
c. If the interface of the dental implantation cellphone conforms to the YY 1012-2004 standard, it is recommended to declare the cell phone as a separate registration unit.
(4) Testing Unit Division
The selection of testing sample machine should be based on product function, performance, clinical indication, safety criteria, key components, structure and combinations, etc. The testing unit division should be based on different configuration rather than different models.
(5) Related standards
GB 9706.1-2007; YY 0505-2012; YY 1045.2-2010; YY 0836-2011; YY 91057-1999; YY 1057-2016; YY 1012-2004; YY/T 0628-2008; GB 4943.1-2011; GB 9706.15-2008; GB/T 14710-2009; YY/T 1400-2016; GB/T 16886.1-2011; YY/T 0268-2008; YY/T 1485-2016
(6) Product techinical requirements and problems that need attention in testing
(9) Other materials
2. On August 9th, CFDA issued a technical review guideline on soft contact lens for comments.
The guideline applies to soft contact lens based on optical correction principle to correct nearsightedness, farsightedness and astigmatism, the deadline for submitting comments is September 10th, 2017. If you have any feedback, please email us info@ChinaMedDevice.com
(1) Registration Unit Division
a. Based on different material formulation except dye
b. Based on different optical design or use
c. Based on different dyeing purpose and methods
d. Based on whether soft contact lens have anti-UV capability
e. Based on different wearing cycle
f. Based on different wear style due to the different design
g. Based on different surface treatment way
(2) Registration Dossier Requirements
a. Summary materials: 1) Chinese name; 2) Product basic information; 3) Working principle and structure diagram; 4) Clarify whether the lens surface is modified; 5) Lens material components; 6) Raw material; 7) Model specifications; 8) Packaging material and specification; 9) Clinical indication and contraindications; 10) Predicate products
b. Research Materials: 1) Performance research; 2)Biocompatibility evaluation research; 3) Manufacturing information; 4) CER; 5) Technical requirements; 6) Registration testing report; 7) IFU
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. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.