Dental Planter CFDA Registration Guideline - Regulatory News - Medical Devices

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’ 醫用電氣設備第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’ 醫用電氣設備第1—2部分:安全通用要求并列標準:電磁兼容要求和試驗
YY 1045.2-2010	Dental phone, part two, straight phone and a curved phone 牙科手機第2部分直手機和彎手機
YY 0836-2011	Dental phone, Dental low voltage electric motor 牙科手機牙科低壓電動馬達
YY 91057-1999 YY 1057-2016	Medical pedal switch general technical conditions 醫用腳踏開關通用技術條件
YY 1012-2004	Dental phone coupling size 牙科手機聯軸節尺寸
YY/T 0628-2008	Dental equipment, Graphic symbol 牙科設備圖形符號
GB 4793.1-2007	Measure, control and lab used electrical devices’ safety requirements, part one, general requirements. 測量、控制和實驗室用電氣設備的安全要求第1部分：通用要求
GB 4943.1-2011	Information technology equipment, safety, part one, general requirements. 信息技術設備安全第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. 醫用電氣設備第1-1部分：通用安全要求并列標準：醫用電氣系統安全要求
GB/T 14710—2009	‘Medical Electrical Equipment Setting Requirement and Testing Methods’ 醫用電器環境要求及試驗方法
YY/T 1400-2016	The determination of chemical disinfectant on the surface of dental equipment. 牙科學牙科設備表面材料耐受化學消毒劑的測定
GB/T 16886.1—2011	‘Medical device biological evaluation, part one: The evaluation and tests in the risk management process’ 醫療器械生物學評價第1部分：風險管理過程中的評價與試驗
YY/T 0268-2008	Dentistry, dental instruments biological evaluation, unit one, evaluation and tests. 牙科學口腔醫療器械生物學評價第1單元:評價與試驗

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