Understanding Record Detail
Rams requires you to enter the following details for every record:
Country - Country or market for a certificate or in which product is registered in.
Record Type - certificate type (e.g., quality, testing, etc.) or enter "product registration" for medical device registrations.
Record Number - the registration’s or certificate’s unique identifying number provided by the approving regulatory authority.
Product/Record Name - Identifying name of the registered product or certificate name.
Version - Initial, Modification, Renewal, Transferred, NA
Manufacturer - The firm that produces the product.
Classification- the product’s classification in the registered country.
RAMS enables you to also enter the details below for each registration/certificate record. Although these details are optional, entering more information will enable you to find registration or certificate record details more easily.
Submission number - unique number assigned upon submission.
Submission date – the date on which the registration or certificate submission was provided to the regulatory authority.
Approval date – the date on which the regulatory authority approved the registration or certificate submission.
Expiration date – the date on which the registration or certificate will expire.
Earliest Renewal date - earliest date a renewal can be submitted to the relevant authorities for official review.
Renewal Deadline– Official deadline to submit a renewal to the relevant authorities
Alert date– the number of months before the expiration date on which the record's status will be set to “Expiring Soon". By default, Rams will set the value to the default alert date set for the registration or certificate country.
Company contact – the name of the individual at your organization who is responsible for or has prepared the registration or certificate.
Local representative – the name of the company or legal entity representing the medical device manufacturer in the registered country.
Local distributors – the names of companies responsible for distributing the product in the registered country/market. Note: this field can contain multiple distributors. To import a spreadsheet containing multiple distributors in a single registration, separate the distributor names with commas. Issued by- name of issuing body.
Device UDI – the product’s unique device identifier. Device part numbers – the part numbers associated with the devices and accessories that constitute the product. Note: this field can contain multiple part numbers. To import a spreadsheet containing multiple part numbers in a single registration, separate the part numbers with commas.
Configuration – a name or description of the particular combination of devices and accessories that constitute the product. Device type – a descriptive label or term for the registered product (e.g., GMDN term, GMDN number, FDA product code, etc.).
Device family – a descriptive label for the product’s device category (e.g., GMDN category, FDA medical specialty). Device class– the product’s classification in the registered country.
Device hardware version– a unique identifier representing the hardware version included in the registered product.
Device software version – a unique identifier representing the software version running on the registered product.
Related records – the names of certificates stored in Rams that are associated with the registration (see Certificates for more information).
Note: A registration can be associated with multiple certificates. If a certificate associated with a registration is nearing expiration, it will also trigger an alert for the registration. Comments– free-text comments about the registration.
Attachments – files related to the records (e.g., submission documents, instructions for use, labels, etc.) that are stored in Rams together with the registration details. Note: you can attach multiple files to a registration. The total number of attachments you can include in your account are determined by the subscription plan you have purchased.
