What You Need to Know
1. What is a medical device?
The term “medical device” covers any product used in healthcare for the diagnosis, prevention, monitoring, or treatment of illness or handicap but excludes drugs.
2. Why does MDA regulate medical devices?
Medical device registration is required so that public health and safety issues can be addressed. Assessments are conducted to ensure the safety and effectiveness of medical devices. With this, the public has the necessary information to make informed choices.
3. Who is responsible for registering a medical device?
The manufacturer of a medical device is responsible for medical device registration. Alternatively, an authorized representative appointed by the manufacturer can be involved. This is for when the manufacturer is based in a foreign country.
4. What is the difference between Class A, B, C, and D medical devices?
The difference between Class A, B, C, and D medical devices is the risk level associated with the vulnerability of the human body. Class A is considered low risk and Class D is considered high risk.
5. What do I need for the medical device registration?
MDA requires various information for registration on the MeDC@St system such as general and manufacturer information, the grouping of medical devices, post-market vigilance history, Declaration of Conformity, etc. You may contact us for further assistance.
We also offer consultation on clinical trial import license.