March 29, 2013

Product Registration

Source: Global Harmonization Task Force - Study Group 1 ghtf_sg1_registration.pdf

Registration of Manufacturers and other Parties and Listing of Medical Devices - GHTF/SG1/N065:2010

Registration: the process by which a party submits information to the Regulatory Authority in a jurisdiction, regarding the identification and establishment location(s) of the manufacturer and other parties, responsible for supplying a medical device(s) to the market in that jurisdiction.

  • Registration provides information on the parties that are or will be, supplying medical devices to the market that is within the RA’s jurisdiction.
  • The RA should identify unambiguously which parties are required to provide it with registration information.
  • Providing registration information to the RA does not remove from that party (i.e. the registering party) its obligation to comply fully with other regulatory requirements that apply to it within the jurisdiction.
  • Medical device manufacturers, authorised representatives, importers and distributors may be subject to registration requirements.

For the purposes of registration, and irrespective of device classification, each registering party should submit the following infor mation to the RA:

1. An indication of whether the registering party is a manufacturer, an authorised representative, an importer or a distributor of medical devices supplied to the market of the jurisdiction where the information is being collected. Some registering parties will fall into more than one of these categories.

2. Name and contact details of the place of business of the registering party, together with the name and post held of the person within that organisation responsible for the registration.

3. Where the registering party has contracted another party to complete the registration process on its behalf, the name and contact details of the place of business of that other party, together with the name and post held of the person providing the required information.

4. An indication that the information provided is either a new entry or an update of previously submitted information. If the second situation applies, the registration code previously allocated to the registered party should be provided.

5. The date when the information is submitted.

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