Table of Contents
Does Thailand require CE Mark for medical devices?
Yes, approval in the Country of Origin is a requirement for registration in Thailand.
How do I get a medical device approved?
To get FDA approval for your medical device, you’ll need to go through the following five steps.
- Know Your Device’s Classification. Medical devices fall into three classes:
- Develop a Prototype.
- Submit Your Applications (If Applicable)
- Wait for FDA Review and Approval.
- Maintain FDA Compliance.
WHO approves new medical devices?
FDA
In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA.
How long does it take to register a medical device with the FDA?
The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.
Can I import medical equipment?
Only two documents will be required from the company who will be importing medical devices, the LTO and the CPR. For exempted medical devices, a certificate of listing will be issued prior to the importation of the device. These new requirement will be coordinated with the Bureau of Customs prior to its implementation.
How do I register my medical device in Indonesia?
For medical devices, only a medical device distributor company can register it. You can open a medical device distributor company if you would like to register the product yourself. Alternatively, you can get a nominee product holder in Indonesia who can hold the product license and register the product on your behalf.
How long does it take to get a medical device approved?
Amendments to the Federal Food Drug and Cosmetics Act in 1976 expanded the agency’s role to oversee safety in the development of medical devices (2). Whereas new drug approval takes an average of 12 years, moving new medical devices from concept to market takes an average of 3 to 7 years (3).
How much does it cost to bring a medical device to market?
The average cost to bring a medical device to market through the 510(k) pathway is $31 million compared to the PMA pathway with average costs of $94 million.
How medical devices are approved in the US?
3 Basic Pathways to Medical Device Approval. There are 3 basic processes to obtain FDA marketing approval for medical devices, depending on the nature of the device and the circumstances under which approval is sought: 1) the PMA process; 2) the PMN process; and 3) the humanitarian device exemption (HDE) process.
How much does it cost to register a product with the FDA?
The FDA registration fee for each medical device establishment is $5,546. All medical device establishments intended to register/renew their facility are required to pay the establishment registration fee.