This is a Glossary page
This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized
R1 Working Definition
One Regulatory Activity, consisting of a collection of Packages (RPS1 Submission Units) (which may be grouped into Reviewable Units), to support one regulatory purpose. The purpose could be a notification of a change, or a request to approve a new product or change.
A Submission is may or may not be reviewed or approved
This varies, including Application, Submission and Sequence.
A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision.
For example, a request for approval to either market a product or to allow the applicant to start testing of a proposed product.
NOTE: In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness.
NOTE: Submissions are always associated with some regulatory action (or inaction). Each submission contains their own regulatory action. Submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units.
NOTE: Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission.
NOTE: Submissions can be the "complete" submission, or some portion of a "reviewable unit". In this setting the kind of regulatory decision is different.
Additional Regional Definitions and Synonyms
Note: Most of these definitions are for a subsequent submission. For definitions and terms for initial submissions, see Application.
- Similar to "hinmoku" in Japanese.
A collection of structured documents, which as a whole is identified by a submission number and to which as a whole a decision is made by Agency.
An application can have multiple submission units.
No difference from "Application" in Japan.
Additional information needed
- PMA Supplement
- IDE Supplement
- Special 510(k)
- HDE Supplement
- Annual Report
- A submission for a change to products already approved on an existing certificate
- A submission to add a new product to an existing certificate
- A renewal under the application for the certificate that is expiring
- Medical Device License Amendment
- Any change request to a registration or renewal approval, including changing the manufacturer name, address, model name, legal contact and service contact in china.
- Manual update notification
- A supplementary submission for a change to an approved license
- A supplementary submission to add new product(s) to an approved license
- Manufacturers Evidence Renewal
- Addition of GMDN code to Manufacturers Evidence
- Addition of DE/TE Certificate to Manufacturers Evidence
- Variation to Full Conformity Assessment (i.e. changes in suppliers or sterilisation protocols or manufacturing site, etc.)
- Variation to Class III or AIMD