What is medical device Vigilance reporting?
What Events are Reported Under MEDDEV Vigilance? In the United States, medical device manufacturers are held accountable to providing reports of known adverse events causing death, adverse events causing serious injury and device malfunctions.
What is PMDA in Japan?
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
What is the difference between MHLW and PMDA?
In conjunction with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA) is an independent agency that is responsible for reviewing drug and medical device applications. The PMDA works with the MHLW to assess new product safety, develop comprehensive regulations, and monitor post-market safety.
What is China FDA called?
The National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA).
What is a medical device incident?
Health Canada defines an MDI as an incident related to the failure of a medical device, deterioration in its effectiveness, or inadequacy in its labeling or directions that led to the death or serious deterioration in health of a patient, user, or other person, or could do so were it to recur.
Who is responsible for notifying the hospital that a medical device in use may cause harm to patients?
Manufacturers
Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. (Key terms are defined in 21 CFR 803.3.)
What is Japan’s version of FDA?
The pharmaceutical regulatory authority of Japan is the Pharmaceutical and Food Safety Bureau (PFSB) of the MHLW.
Where is PMDA located?
Japan
The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in Japan in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects.
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