Medical Device

TFDA

http://www.fda.gov.tw/EN/index.aspx

Appoint a License Holder in Taiwan
Product Classification： Class I (low risk), Class II (medium risk), Class III (high risk)
QSD letter
Product Registration

Medical Device Registration in Taiwan
The medical device registration for Taiwan FDA includes two steps. The first step is to apply for QSD letter by providing QMS documents. The second step is to apply for product registration by providing technical documents for review. These two steps could be applied in parallel. For Class III device, it is necessary to provide documents in STED (Summary of Technical Documentation) format according to Guidance published by Global Harmonization Task Force,GHTF

Step 1： QSD letter
It is necessary to apply for QSD letter in order to prove that the physical manufacturer is in compliance with Taiwan GMP （ISO 13485）. You may provide quality system documents for review instead of onsite inspection.

Step 2： Product approval
Make sure that the product is allowed to be market on the original country by providing the FSC （or CFG）. Provide product dossier to prove that the device performs as safe and effectiveness as the predicate device.

License Holder
We could be your license holder in Taiwan.

Flow Chart
Submission Package Preparation → Acceptance Review → 1st Review TFDA （3months） → Additional Information Request （2 months） → 2nd Review TFDA （3 months）→ Defense （4 months）→ Final Review TFDA （3 months）→ Finalized

US FDA

http://www.fda.gov/default.htm

We are familiar with US FDA medical device regulation and quality system regulation (QSR) GMP compliance or MDSAP.

US FDA medical device premarket notification 510 (k)
US FDA medical device premarket approval PMA

Product Classification：Class I, Class II, Class III
Preclinical Study Counseling
Technical documents preparation
Response to Reviewer’s questions
Acquire 510 (k) clearance letter or PMA
Appoint an Agent in US
Establishment Registration and product listing

CDRH
http://www.fda.gov/medicaldevices/default.htm

Device Classification Panel
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
ClassifyYourDevice/ucm051530.htm

510 (k) Submission: Traditional, Abbreviate, Special
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarke
tYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

PMA
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarkety
ourdevice/premarketsubmissions/premarketapprovalpma/default.htm?utm_campaign
=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=PMA&utm_content=3

Registration and Listing
https://www.access.fda.gov/oaa/

	EU CE Marking
http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm Related Law MD Directive IVD Directive Directive 93/68/EEC: CE marking Directive 93/42/EEC: Medical Devices Directive 98/79/EC: In vitro diagnostic medical devices Directive 2000/70/EC: medical devices incorporating stable derivate of human blood or human plasma Directive 2001/104/EC: amendment Directive 2007/47/EC: amendment harmonised standards under Directive 93/42/EC for Medical devices harmonised standards under Directive 98/79/EC for In vitro diagnostic medical devices
Product Classification MD：Class I, Class II a, Class II b, Class III IVD：Class A, Class B, Class C, Class D Preclinical Study Counseling Technical construction File preparation Acquire ISO 13485 and EC certificate by notify body Appoint an authorized representative in EU

Medical Device Classification
Part I
http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf

Part II
http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_2_4-1part2_07-2001_en.pdf

	Health Canada
http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php
Product Classification：Class I, Class II, Class III, Class IV CAMCAS ISO 13485 certificate Preclinical Study Counseling Submission package preparation Response to Reviewer’s questions

List of registrars recognized by Health Canada
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_regist-eng.php

	RUSSIA DOH
http://roszdravnadzor.ru/en
Product Classification：Class1, Class2a, Class2b, Class3 CMP/ISO 13485 compliance Preclinical Study Counseling Submission package preparation Performance testing by Russia certified lab Response to Reviewer’s questions Clinical assessment Finalized

Latin America
ISO 13485:2003 certificate Product Classification：Class I, Class II, Class III, Class IV Brazil GMP compliance Technical documents preparation Electronic equipment certified by Inmetro Submission package preparation and Response to Reviewer's questions

	Brazil ANVISA
Agencia Nacional de Vigilancia Sanitaria


	Argentina ANMAT
National Administration of Drugs, Foodstuffs and Medical Technology
http://www.anmat.gov.ar/Medicamentos/Medicamentos.asp

	Mexico ANMAT
Ministry of Health
http://ita.doc.gov/td/health/mexicoregs.html

	Colombia IN√IMA
https://www.invima.gov.co/

	Peru DIGEMID
http://www.digemid.minsa.gob.pe/

	NMPA
http://eng.sfda.gov.cn/WS03/CL0755/
Product Classification: Class1, Class2, Class3 CMP/ISO 13485 compliance Product requirement standard writing Preclinical Study Counseling Submission package preparation Performance testing by NMPA certified lab Response to Reviewer’s questions

	Japan's Ministry of Health, Labor and Welfare (MHLW)
http://www.mhlw.go.jp/english/index.html
Foreign Manufacturer compliance with GMP
Product Classification GMP compliance preparation Preclinical Study Counseling Technical documents preparation Response to Reviewer’s questions MAH