Medical Device Master File (MAF)
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Registrar Corp can assist you with the following:
- File a new MAF
- Update or Amend an existing MAF
- Appoint Registrar Corp as your Agent
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If you would like to file a new Master File (MAF) with FDA
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If you already have a MAF number with FDA
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| Seçenek 1: Update your existing MAF
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Click the Update button below for any of the following:
- Amend your MAF
- File an Annual Update
- Reactivate a MAF
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Seçenek 2: Order a Certificate of Filing issued by Registrar Corp for your existing MAF
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Companies registered with FDA often are asked by their customers and suppliers to verify their MAF filing. A Certificate of Filing issued by Registrar Corp serves to verify your MAF
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Applicable U.S. Regulations:
FDA Regulation: 21 C.F.R. section 814.9.
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A master file for devices (MAF) is a way to preserve trade secrets of medical device companies and their suppliers. A medical device company often needs to submit information about their supplier's product, facility or process. The MAF allows each company to submit its own confidential data to FDA without it being disclosed to anyone outside FDA.
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| Registrar Corp FDA düzenlemeleri ile ilgili konularda danışmanlık hizmeti verir. Registrar Corp tarafından yayınlanan Kayıt sertifikanız sizin FDA kayıt gereklerine uygunluğunuzu doğrular. FDA kayıt sertifikası yayınlamaz veya kabul görmez. Registrar Corp, ABD Gıda ve İlaç İdaresine bağlı değildir.
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