【醫療器材管理法】５月１日正式上路

Honesty•Accuracy

Professionalism•Responsibility

Honesty•Accuracy

Professionalism•Responsibility

Honesty•Accuracy•Professionalism•Responsibility

Core Value

About
MDG

Medgaea Life Sciences is a third party laboratory that is certificated for OECD GLP, TFDA GLP, ISO 17025 and ISO 9001. Maily based on preclinical CRO, we provide total-soltion services to assist biotechnology industries successfully obtain the product certification and exploit internation market.

CRO

Needs Discuss
Quote and Ordar
Timetable Schedule
Report Launch
Case Closed

Services

With devoting to our core value 『Honesty•Accuracy•Professionalism•Responsibility』,

We have successfully assisted our customers to successfully obtain the product certification in FDA, CE, TFDA and NMPA.

Medical Devices

One of the first priority of medical devices R&D is their safety. The Biocompatibility test is mainly followed the ISO 10993 international standard.

Cell therapy and Regenerative medicine

We assist the safety, effectiveness tests during the R&D process of cell therapy product. All the tests are complied with GLP.

Pharmaceutical development

As the agent of SNBL in Taiwan, will help new drugs company to complete non-clinical trials in medium, large animals and primates in the research and development stage.

Agrochemical and Enviromental Agents

The agroculture products need to review their toxicological data in advance, and all the tests must be carried out in complies with GLP.

Chemical Substances

Providing the toxicological test information!
EPA acquired the test information as the core basis to evaluate the substance announcement.

Health Food/ Ingredients

Provide safety, efficacy and stability tests for food ingredients and health foods.

Registration

Provide registration services.

Pharmaceuticals

Provide batch examine for medicine release, including pyrogen, acute systemic toxicity and other tests.

Laboratory animals and Equipment

An agent and supplier based on research and development of animal experiments, providing import services for various disease model animals in research institutions.

「醫療器材管理法」於109年1月15日總統公布，行政院於110年2月17日定自110年5月1日起施行，法案條文共85條。

我國醫材獨立法規「醫療器材管理法」上路後，將進一步保障國人使用醫療器材之安全、效能及品質，業者執行業務於法有據，並進一步到位，有更多機會佈局國際市場，民眾取得醫材也變得更方便，使得國人享受與國際同步的高水準醫材，為我國醫療器材產業邁入國際，開啟嶄新的扉頁。

資料來源 : 衛生福利部食品藥物管理署