New Requirements for FDA Medical Device Establishment Registration and Listing

As I mentioned in a previous blog, FDA is updating their requirements for Medical Device Establishment Registration and Listings. The changes begin in four days, starting October 1, 2012. The two biggest changes that I initially noted were as follows:

  1. ALL establishments (including initial distributors / initial importers) will need to start paying the registration fee. In the past, initial distributors/importers were exempt from paying the registration fee.
  2. The registration fee will be increasing from $2029 to $2575.

One thing I forgot to make note of was another new requirement for initial distributors/importers. They must now “Identify manufacturers of products being imported. This may be done by listing number or searching and identifying the manufacturer in FURLS.”

The official response from FDA’s FAQ page on the new requirements has this blurb about identifying the manufacturer:

16. As an initial distributor/importer who is now required to provide the manufacturer information for devices I will be importing, must I update this information in FURLS as new firms are added or I decide not to distribute for a particular manufacturer?

FDA recommends that importers keep their manufacturer information current at all times. Failure to keep your information current may lead to your device undergoing manual review when imported, which may slow importation of your device.

We all know how bogged down and slow FDA’s response has become over the last few years. Most FDA offices are way underfunded and overworked. One thing that FDA continues to repeat to the importing community is that the best way to help them speed up the process is by making sure all the information provided to them is up-to-date. Keeping manufacturer information up to date on FURLS is just one such action that every importer should be taking.

-Jimmy Ting

jimmyting@great-world.com

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