最新ニュース - クアルテックジャパンコンサルティング株式会社

Class A

Class B

Class C

Class D

Mandatory registration

Product listed in Annex of Circular 30

1.Must apply import license, valid until 12/31/2019

※Import license with validity until 12/31/2018 will be automatically extended until 12/31/2019

Product NOT listed in Annex of Circular 30

1. Allowed to import w/o import license

2. Need to show classification result when importing

Qualtech can support for the classification inquiry with MoH.

      Category

Class 1

Class 2

Class 3

Description

MD to be licensed

MD to be notified

General MD to be applied import license

Products listed

• Condom
• Surgical gloves
• HIV screening kit
• Contact lens
• blood bags

• Physical therapy devices
• Alcohol detectors
• silicone breast implants
• breast enhancers
• Methamphetamine Urine Drug Test Kits
• Ophthalmic Viscosurgical Devices

Device not listed under classes 1 & 2 (90% of all applications)

編號

日本醫療器材驗證機構登錄名稱

日本登錄號碼

01

TUV Rheinland Japan

第AB號

02

BSI Group Japan

第AD號

03

SGS Japan

第AF號

04

TUV SUD Japan

第AA號

完整模式

Full mode

美國廠簡化

USA factory

歐洲廠簡化

EU factory

日本廠簡化

JP factory

ISO 13485 Certificate

V

V

V

V

品質手冊　

Quality Manual

V

V

品質程序　

Quality Procedures

V

文件總覽表　

Table of Content

V

V

查廠報告

Audit Report or EIR (Establishment Inspection Report)

V

V

V

製售證明

FSC (Free Sales Certificate) or CFG (Certificate for Foreign)

V

V

全廠配置圖

Layout

V

V

產品製造作業區域圖

Production Area

V

V

製造及檢驗設備　Facilities

V

V

產品製造流程　

Working Flow

V

V

Taiwan recall & report procedures

V

O

(if audit report follow Taiwan TCP)

O

(if audit report follow Taiwan TCP)

V