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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’ 醫(yī)用電氣設(shè)備第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’ 醫(yī)用電氣設(shè)備第1—2部分:安全通用要求并列標(biāo)準(zhǔn):電磁兼容要求和試驗(yàn)
YY 1045.2-2010	Dental phone, part two, straight phone and a curved phone 牙科手機(jī) 第2部分直手機(jī)和彎手機(jī)
YY 0836-2011	Dental phone, Dental low voltage electric motor 牙科手機(jī) 牙科低壓電動(dòng)馬達(dá)
YY 91057-1999 YY 1057-2016	Medical pedal switch general technical conditions 醫(yī)用腳踏開關(guān)通用技術(shù)條件
YY 1012-2004	Dental phone coupling size 牙科手機(jī) 聯(lián)軸節(jié)尺寸
YY/T 0628-2008	Dental equipment, Graphic symbol 牙科設(shè)備圖形符號(hào)
GB 4793.1-2007	Measure, control and lab used electrical devices’ safety requirements, part one, general requirements. 測(cè)量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求第1部分：通用要求
GB 4943.1-2011	Information technology equipment, safety, part one, general requirements. 信息技術(shù)設(shè)備安全第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. 醫(yī)用電氣設(shè)備第1-1部分：通用安全要求并列標(biāo)準(zhǔn)：醫(yī)用電氣系統(tǒng)安全要求
GB/T 14710—2009	‘Medical Electrical Equipment Setting Requirement and Testing Methods’ 醫(yī)用電器環(huán)境要求及試驗(yàn)方法
YY/T 1400-2016	The determination of chemical disinfectant on the surface of dental equipment. 牙科學(xué)牙科設(shè)備表面材料耐受化學(xué)消毒劑的測(cè)定
GB/T 16886.1—2011	‘Medical device biological evaluation, part one: The evaluation and tests in the risk management process’ 醫(yī)療器械生物學(xué)評(píng)價(jià)第1部分：風(fēng)險(xiǎn)管理過程中的評(píng)價(jià)與試驗(yàn)
YY/T 0268-2008	Dentistry, dental instruments biological evaluation, unit one, evaluation and tests. 牙科學(xué) 口腔醫(yī)療器械生物學(xué)評(píng)價(jià) 第1單元:評(píng)價(jià)與試驗(yàn)

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Dental Planter CFDA Registration Guideline