OVERSEAS CERTIFICATION

Foreign Medical Device Certification

Medical Device Certification

Our company pushes forward pre/post authorization and quality control under certification systems, such as FDA(US), EU (European), CFDA (China), and PMDA(Japan).

FDA(US)

Definition Medical Device in FDA(US)
  • Instrument, machine, implant device, in vitro reagent, or other similar or related articles is intended to treat, prevent, mitigate, diagnose human diseases. Including all of the following accessories.
    1. (1) Instrument, machine, implant device, in vitro reagent, or other similar or related articles is intended to treat, prevent, mitigate, diagnose human diseases. Including all of the following accessories.
    2. (2) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
    3. (3) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals.
Medical Device classification in FDA
  • There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, the risk to the patient and FDA regulatory control increase.
Detail of consulting contents
  • FDA 510(k)
  • PMA(Pre-Market Approval)
  • Labeling
  • MDR(Medical Device Regulation)
  • PMS(Post Merket Surveillance)
  • US QSP(Quality System Regulation)
  • SaMD(Software as Medical Device)

EU (European)

Definition Medical Device in European (CE)
  • Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings.
    1. (1) Diagnosis, prevention, monitoring, prediction, treatment or mitigation of disease.
    2. (2) Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.
    3. (3) Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
    4. (4) Management of Conception
Medical device classification in CE
  • The medical device is classified into four classes (Class I Class IIa Class IIb Class III) according to the risk level of the medical device. Through MDD Annex IX and the Medical Device Guidance Document (MEDDEV 2.4/1 Reuse 2010), Classification is under 18 principles based on the basic criteria of classification (period of use, insertion, reuse, and contact area).
Detail of consulting contents
  • CE marking
  • Labeling
  • MDR(Medical Device Regulation)
  • PMCF(Post Market Clinical Folow-up)
  • ISO 13485:2016

CFDA (China)

Definition Medical Device in CFDA (China)
  • Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
    It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives.
    • Diagnosis, prevention, monitoring, treatment or alleviation of disease.
    • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions.
    • Investigation, replacement or modification for anatomy or a physiological process.
    • Life support or maintenance
    • Control of conception
    • Providing information of medical or diagnosis data through a sampling inspection originating in the human body.
Medical equipment classification CFDA
  • The medical device is classified into grades 1, 2 and 3, from low-risk products to high-risk products. based on the risk level in China.
  • The list of medical device classifications is frequently adjusted based on the production, use, and sale of medical devices, and use conditions.
Detail of consulting contents
  • Medical device approval registration
  • Report adverse of medical devices
  • Medical device advertising
  • Quality control ISO 13485.

PMDA(Japan)

Definition Medical Device in PMDA(Japan)
  • Medical devices are products used for treating or preventing diseases of people or animals or machine tools used for influencing the structure and function of the body (excluding regenerative care products) under law.
Medical equipment classification in Japan (PMDA)
  • The medical device is classified into Class 4 in Japan, and they give its own code to its products which has more than 4,000 items registered in the GMDN, an international medical device naming system. The MDN code will be determined and notified by the notice at an appropriate time.
Detail of consulting contents
  • Manufacturing approval from PMDA (Proliferation and Medical Certification Authority)
  • RCB(Registered Certification Body)
  • QSP(Quality System Regulation)
  • Surveillance
  • JGMP

The other overseas

Brazil, Canada, Australia, Southeast Asia etc.