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

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

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

Device Classification Panel

510 (k) Submission: Traditional, Abbreviate, Special

PMA

Registration and Listing

	EU CE Marking
EU Reguation MD Regulation IVD Regulation 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
Part II

	Health Canada
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

	RUSSIA DOH
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

	Mexico ANMAT
Ministry of Health

	Colombia IN√IMA

	Peru DIGEMID

	NMPA
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)
Foreign Manufacturer compliance with GMP
Product Classification GMP compliance preparation Preclinical Study Counseling Technical documents preparation Response to Reviewer’s questions MAH

​License Holder

Flow Chart

License Holder