解決方案

我們提供多元市場進入解决方案

進行多地上市註冊是每個醫療器材公司頭痛的事情，除了要對接不同公司的聯繫窗口，還要疲於應付各地衛生主管機關提出的問題。

理工科技提供您多國註冊的解決方案，您只需要與單一窗口聯繫，並僅準備一套文件，就能同時在多國取得上市許可，同步展開亞洲市場。

ASEAN AMDD Medical Device Regulation Comparison Table

	SINGAPORE	MALAYSIA	INDONESIA	PHILIPPINES	VIETNAM	Thailand
AMDD Compliance	Fully	Fully	Fully	New Regulation (Phase 1) commencement on March 13, 2020	New Regulation following AMDD will be implemented in 2022.	CSDT format for Class II (MD to be notified) and Class I (MD be licensed) & PMAS
Regulator	Health Sciences Authority (HSA)	Medical Device Authority (MDA)	Ministry of Health (MoH)	Philippines Food and Drug Administration (PFDA)	Ministry of Health (MoH)	Thai Food and Drug Administration (TFDA)
Laws	No. S 334 /2016 Health Products (Medical Devices) Regulation	Act 737 Medical Device Act 2012	MOH Regulation No. 62 year 2017 (Marketing Authorization License Manufacturer)	AO 2018:002 Circular 2020-001	Decree No. 36/2016/ND-CP & Decree No. 169/2018	Medical Device Act 2008 & 2019
Review by Conformity Assessment Body( CAB)	GDPMD/ISO 13485	ISO 13485/ GDPMD First Stage of PR	NA	NA	NA	NA
Who shall do the registration	Local Registrant	Authorized Representative (AR)	Local Importer	Importer	Local AR or Distributor	Importer
Classification	A, B, C, D	A, B, C, D	A, B, C, D	A, B, C, D	A, B, C, D	III, II, I
Validity of Certificate	Annual Retention	5 years	2~5years According LOA	CMDN (Class A): Permanent CMDR(Class B, C, D) : 5 years	Class A: Permanent Class B, C, D: 5 Years	Class I, II: 5 years Class III: according to FSC
QMS Requirements	ISO 13485	ISO 13485	ISO 13485	ISO 13485 Or local GMP equivalent	ISO 13485	ISO 13485 Or local GMP equivalent

執行臨床試驗的時程漫長，無法跟上變化迅速的市場。或是收到的臨床試驗報告不符合註冊審查規定，導致需要重啟臨床試驗。

理工科技以註冊經驗執行臨床試驗，符合當地衛生主管機關需求；我們通盤了解亞洲市場的臨床試驗要求，讓您可以將一份臨床試驗報告用於多地註冊。

亞洲多數國家的資訊以當地語言提供，讓許多有興趣進入市場的醫療器材公司無法順利取得即時資訊，以便擬定合適的市場規劃。

理工解決提供您多地區法規調研、市場調查、產品標準評估與競爭品搜索服務，讓您的公司迅速掌握目標市場的環境，擬定精準高效的市場准入策略。