Dental Planter CFDA Registration Guideline

The dental planter are regulated as class II medical devices (6855) under CFDA regulations. Foreign manufacturers are required to obtain the imported medical device registration certificate from CFDA for their dental planters in China. On July 29^th 2016, CFDA issued the “Technical Guidelines for Dental Planter (Exposure draft)”. And dental planter CFDA registration should be conformed to this guidelines.

CFDA Clinical Trial Exemption

According to the “Catalog of Class II Medical Devices Exempted from Clinical Trials” (first batch 21^st Aug. 2014), the dental planter described as below can be exempted from clinical trials in China.

Registration Guideline Applicable Objects

Apply to:
This guideline applies to the electric drive type dental planter. The dental planter is a medical electrical equipment to perform dental implant surgery.

Key Points of Technical Requirement:

1. Product naming requirements
2. Product applicable scope requirements
3. Product describing documents
Based on different structure, dental planters can divide into three types of power supply: built-in, grid power supply and internal power supply. The applicants should submit the complete devices describing documents, including model, specification and configuration.
4. Research documents.

Biocompatibility research documents
Sterilization research documents.

5. The registration unit division.
6. Testing unit division.
7. Product applicable standards. (see chart 1 listed below)
8. Product technical requirements and testing problems that should be paid attention to.
9. Product instruction.
10. Product applicable related standards.
11. Product clinical evaluation documents.
12. Other documents.
Chart 1 Related Product Standards

GB 9706.l—2007	‘Medical Device Electrical Equipment, Part One :safety general requirements’ 医用电气设备第1部分:安全通用要求
YY 0505—2012	‘Medical Electrical Equipment- part 1-2: safety general requirement collateral standard: electromagnetic compatibility requirements and test’ 医用电气设备第1—2部分:安全通用要求并列标准:电磁兼容要求和试验
YY 1045.2-2010	Dental phone, part two, straight phone and a curved phone 牙科手机第2部分直手机和弯手机
YY 0836-2011	Dental phone, Dental low voltage electric motor 牙科手机牙科低压电动马达
YY 91057-1999 YY 1057-2016	Medical pedal switch general technical conditions 医用脚踏开关通用技术条件
YY 1012-2004	Dental phone coupling size 牙科手机联轴节尺寸
YY/T 0628-2008	Dental equipment, Graphic symbol 牙科设备图形符号
GB 4793.1-2007	Measure, control and lab used electrical devices’ safety requirements, part one, general requirements. 测量、控制和实验室用电气设备的安全要求第1部分：通用要求
GB 4943.1-2011	Information technology equipment, safety, part one, general requirements. 信息技术设备安全第1部分:通用要求
GB 9706.15-2008	Medical Electrical Equipment, part 1-1: general safety requirements, Collateral standards: Medical electrical system safety requirements. 医用电气设备第1-1部分：通用安全要求并列标准：医用电气系统安全要求
GB/T 14710—2009	‘Medical Electrical Equipment Setting Requirement and Testing Methods’ 医用电器环境要求及试验方法
YY/T 1400-2016	The determination of chemical disinfectant on the surface of dental equipment. 牙科学牙科设备表面材料耐受化学消毒剂的测定
GB/T 16886.1—2011	‘Medical device biological evaluation, part one: The evaluation and tests in the risk management process’ 医疗器械生物学评价第1部分：风险管理过程中的评价与试验
YY/T 0268-2008	Dentistry, dental instruments biological evaluation, unit one, evaluation and tests. 牙科学口腔医疗器械生物学评价第1单元:评价与试验

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