Does Thailand require CE Mark for medical devices?

Yes, approval in the Country of Origin is a requirement for registration in Thailand.

How much does it cost to register a medical device with FDA?

FDA has published the annual establishment registration fee for FY 2021, which will be effective from October 1, 2020. The FDA registration fee for each medical device establishment is $5,546.

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.

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 do I apply for a medical device?

If you are a currently enrolled DME provider that is not located out-of-state or in one of the counties that was subject to the moratorium, you do not need to be screened as “high” risk.

What devices need FDA approval?

What products need to be FDA approved? FDA approval is usually mandatory to market or sell products in the US that might have a significant risk of injury or illness, but can also benefit your health — such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.

How do you become FDA registered?

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

How do I become an FDA importer registered?

Importers can register with the FDA at their website. Food facilities in both the US and the exporting country can also register at the corresponding page on the FDA website. Once you have registered, you will be given a seven-digit identifier. This code will be required for FDA Prior Notice.

How do you license a medical device?

Since 2008, the State of California has required medical device manufacturers physically located in California to be licensed with the state. That process involves filing an application, paying a filing fee and allowing state officials to inspect the facility prior to granting the license.

Can you ship medical devices internationally?

You can in fact ship medical devices to foreign countries. Foreign countries often ask companies to provide proof of FDA approval in the form of a Certificate to Foreign Government. FDA-approved medical devices that are legally marketed in the United States can ship anywhere in the world without any issues.

What do you need to know about Thai FDA registration?

Thai FDA Registration. The Thai FDA groups medical devices into 3 classes’ sub-categories as follows: Class 1 medical device: condoms, surgical gloves, syringes and diagnostic test kits. Class 2 medical devices: rehabilitation devices, blood alcohol level measuring kits, silicone implants, and test kits other that for diagnostic purposes.

Do you need a license to sell medical devices in Thailand?

Also it is compulsory to have the Certificate of Free Sale in the Country of origin. Class I “Licensed” Devices: Thai Class 1 devices need a license for sale in Thailand. They must show compliance with Thai Industrial Standards and in certain cases undergo testing by the Thai FDA.

What is the classification of medical devices in Thailand?

The classification system by Thai FDA is reverse of the US FDA with Class I devices having the highest risk. They are referred as “general devices” and Class II referred as “notification”. Additionally, import of used / refurbished equipment is prohibited in Thailand.

How do I import pharmaceuticals into Thailand?

Importing pharmaceuticals, food, food supplements, products for animal health, or other medical, narcotic and toxic substances into Thailand requires registration with the Food and Drug Administration of Thailand (FDA).