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Global Device Registration Dossier Assembly

Medical device registration work that builds each country's dossier from the core technical file, cites every value to its page, and shows which licenses one change reaches.

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Follow one site change from 09:10 to a checked filing ↓
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The problem

One core file rebuilt by hand for each regulator, and changes nobody traces

A catheter family sold in dozens of markets carries one core technical file, yet each regulator wants that evidence in its own order, language and forms. Regional specialists copy the sterilization validation, the risk summary and the test reports into each dossier, then chase the certificates and apostilled letters that expire on their own clocks.

When the core file moves on, translated instructions and product requirements fall behind without anyone noticing. When a second sterilization site is added, somebody has to read each license to see whether it names the old site, apply that country's rule, and work out the date a filing is due before the first lot ships.

Built forRegulatory affairs leadsRegional specialistsLabeling coordinatorsQuality reviewers

The Problem Today

Each country wants the same evidence in its own order, language and forms, and one change can reach dozens of licenses.

$175
for the first US export certificate; $85 for each more published
5 years
China certificate life; renewal filed 6 months before expiry published

Rebuilt by hand for each country

  • Dossiers
  • Letters
  • Languages
  • Deadlines
  • Certificates age outEach country accepts its own age and legalization
  • Change calls made from memoryWhether a site is named sits inside each license

The Solution

  1. Built from one core fileEach requirement filled from the core file and cited to its page
  2. Gaps named in plain wordsAn expired certificate, an old translation, a report too old to accept
  3. One change, read license by licenseWhat each license names, the country's rule, and the date it implies
  4. Leads decide and signA lead signs only their own countries, after opening each attachment

Built-in controls

  • Agents file nothing with a regulator
  • Each lead decides only their own countries
  • A no-filing call waits for a second reader

What You Get

Dossiers that keep pace with the core file, and a dated, cited reason behind each filing decision.

  • Lots held where not yet coveredShip-holds placed at once, released only by two people
  • Renewals filed in the right orderA site change waits where it would block a renewal
  • Gaps found before a regulator doesEach with the rule that makes it a gap
One catheter family, fourteen dossiers

A medical device registration morning: one new sterilization site, ten filings

An irrigated ablation catheter in 22 codes, a core technical file on Rev F, and a second ethylene oxide site released by change control the day before. The international regulatory affairs manager starts at the grid.

demoCompany, catheter, sites, people and figures here are all sample data, invented for the working solution.

  1. 0109:10

    198 requirements across 14 countries, and a change nobody has traced

    International regulatory affairs manager

    One column per country, one row per requirement, each cell a small mark: filled and cited, gap, in progress, signed input. The header counts 169 filled, 17 gaps and 294 of the family's 340 registration records. An amber band warns that the new site has not been traced, and the next-step line points at the renewal in China, 78 days out.

  2. 0209:14

    Five agents re-read Rev F and name the same 17 gaps, each with its rule

    International regulatory affairs manager

    She asks for a fresh assembly from Rev F. The plan shows each agent's part: the core file reader indexes 15 documents, the rules agent applies 14 rule lists, the certificate keeper checks 24 certificates and letters, the translation checker compares 11 languages with the English master. Nothing is marked ready by an agent; the gaps go to the three regional leads.

  3. 0309:15

    China's renewal dossier still carries instructions written for Rev D

    International regulatory affairs manager

    China's column opens as a dossier in the regulator's own order, each line cited to a page of the core file. Four lines are gaps. Instructions for use in Chinese are on Rev D, and the product technical requirements still hold the flow tolerance of Rev E. An electrical report must be redone to the national standard, and the agent's appointment letter expires before the renewal can be filed.

  4. 0409:16

    One sterilization site change lights 10 of 14 country columns

    International regulatory affairs manager

    She starts the ripple. The tracer reads the change record, the validation of the new site and 14 licenses for what each one names, then applies each country's rule. Ten countries need a filing and two must be confirmed locally. 212 of 340 records are touched, and 12 ship-holds go into the ERP at once, so lots from the new site wait.

  5. 0509:17

    Four countries are already past their planning time

    International regulatory affairs manager

    Each row cites what that country's license names and the rule applied, then shows the sum behind its date: the first shipment less the planning time. Taiwan and Brazil needed 120 days, India 180, and India is also blocked because its certificate of free sale expired. The earliest ship date if filed now sits under each late row, so nobody has to work it out.

  6. 0609:20

    Korea's import license names the old site, so a change approval is drafted

    Regional regulatory lead

    The regional lead who owns Korea opens its filing in his own view. Each sentence carries a numbered citation back to the change record, the validation report or the license. The four attachments this kind of filing needs are listed below it, each marked not opened, and the file-by date sits in the header: seven days.

  7. 0709:24

    He opens all four attachments before his signature is allowed

    Regional regulatory lead

    He reads the sterilization validation, the residuals report, the site review application and the equipment comparison. Only when each shows opened can he sign, with his own password and the meaning that he approves this filing for submission. The filing becomes signed and ready; he still submits it through the regulator's own portal himself.

  8. 0809:26

    A second reader opens the license and the validation before she agrees

    International regulatory affairs manager

    Back in her own view, she checks the decision. The check lists what to open first: the page of the license that names the old site, and the validation of the new chamber. Agreement stays locked until both are open, so a decision is never confirmed on the lead's word alone. Then she agrees and signs.

  9. 0909:26

    Holds on new-site lots lift only on a regulator's approval, by two people

    International regulatory affairs manager

    Further down the ripple, China keeps the new site out until its renewed certificate is issued, and Japan waits for a quality system check. The no-filing proposals for the United Kingdom and Switzerland wait for their lead, then for her. Each hold card says who may lift it: the quality reviewer with the regional lead, once the regulator's approval is attached.

What the grid caught that a country-by-country checklist would pass

Each one is a value that looked filled until an agent read the page behind it.

Instructions a revision behind

Instructions in Chinese were still on Rev D, so a changed flow table and two warnings never reached them.

A free-sale certificate past its date

The certificate India's prior approval needs had expired, so that filing cannot go in until a new one arrives.

A license that names the old site

Korea's import license names the first sterilization site, so the change needs approval before import even with the same cycle.

A change that would block a renewal

China's change registration must finish before a renewal, so the new site stays out of China until the renewed certificate is issued.

Six licenses, six different answers to one site change

The tracer cites what each license names, then applies that country's rule. Planning times are the customer's own estimates.

CountryWhat the license namesProposed filing and planning time
KoreaThe first site, on the import licenseChange approval before import, with a site review; 90 days
TaiwanThe first site, in the quality system letterAmendment before import; 120 days, already late
BrazilThe first site, on the GMP certificate scopeChange petition and certificate extension; 120 days, already late
IndiaEach manufacturing and sterilization sitePrior approval, blocked by the expired certificate; 180 days, already late
ChinaProduction addresses on the certificateNew site kept out until the renewal is through; 180 days
United KingdomThe device and the manufacturer, no sitesNo filing, proposed for a second reader

demoSample data, from the working solution.

Behind the fourteen dossiers

Certificates, translations and renewals that feed medical device registration

What the regional leads, the labeling coordinator and the manager read between changes.

One cell, one passageA filled cell opens the requirement, the source document and page, and the highlighted passage the dossier assembler matched.
24 certificates and lettersEach certificate with what it covers, its dates, the countries using it and their age rule; 5 are not usable as they stand.
Translations against Rev FInstructions and labels in 12 languages, set against the English master. The row for Chinese opens on the three changed sections, sentence by sentence, before anything goes to the translators.
Renewals on one timelineExpiries and renewal windows for the family, with the plan that files China's renewal first and its site change after.
33 country rulesWritten by the regional teams, each with its source, owner and last review. A rule change needs the manager's signature.
The audit trailEach read, trace, signature and check, stamped with the person or agent, the time and what each signature attests. It exports as CSV or JSON evidence.

demoSample data, from the working solution.

Where the dossier facts come from

Systems of record, read in place. The filings leave through each regulator's own portal, in a person's hands.

Product lifecycle managementThe core technical file and its revisions, read by section and page
Regulatory information managementRegistrations and licenses, country by country and code by code
Document managementCertificates, appointment letters, apostilles and their dates
Quality managementChange records, validations and quality system certificates
ERPWhere ship-holds are placed and lifted
Translation provider portalChanged sections go out; returned translations come back unread until someone checks them
Country rule libraryThe regional teams' own rules and planning times
Who reads the core file

Eight agents assemble, compare and draft; the leads decide each country

Each shows its plan, the sources it read and a confidence, then hands to a named person.

Core file reader

Indexes the core technical file by document, section and page.

  • Never changes a source document
Country rules agent

Applies each country's rule list to build its checklist.

  • Never writes or relaxes a rule
Dossier assembler

Fills each cell from the right revision, in the country's order.

  • Never marks a dossier ready
  • Never submits
Certificate keeper

Tracks certificates, letters, legalization and accepted ages.

  • Never requests a certificate from a government by itself
Translation checker

Lists the sections each language is missing against the master.

  • Never translates a warning or a claim
Change ripple tracer

Reads what each license names, applies the rule and proposes a date.

  • Never decides whether a regulator must be told
  • Never releases a hold
Filing drafter

Drafts each country's filing from cited sources.

  • Never signs or sends anything to a regulator
Renewal clock

Computes renewal windows and the order of dependent filings.

  • Never moves a regulator's date

Whether a regulator must be told stays a person's call

The agents propose and cite. These decisions stay with named people.

NotifiabilityA regional lead decides each country's filing with a reason code; a no-filing call waits for the manager to read it.
SubmissionThe lead submits through the regulator's portal and records its reference; agents draft only.
Lifting a ship-holdThe quality reviewer and the regional lead release it together, after opening the regulator's approval.
Country rulesRules belong to the regional teams, and a change needs the manager's signature.
Post-market historyWhere a dossier asks for it, the complaint handling team supplies one signed document that the agents never open.

What regulatory leads ask about medical device registration

What is medical device registration dossier assembly?

Medical device registration means filing a device with each country's regulator in that country's own order, language and forms. This solution builds each dossier from one core technical file, cites each value to its page, names each gap, and traces a change to the licenses it reaches.

Does it decide whether a change needs a filing?

No. It reads what each license names, applies the country's rule from your library and proposes a filing kind and a date. The regional lead decides, and a decision that no filing is needed waits for a second reader.

Whose country rules does it apply?

Your regional teams' own. Each rule carries its source, owner and review date, and the planning times are your estimates, not a regulator's.

Can it submit to a regulator?

No. It drafts the filing and lists the attachments; the lead opens each one, signs, submits through the regulator's portal and records the reference.

How are translations handled?

The translation checker compares each language with the English master and lists the changed sections. A qualified translator translates them, and a returned translation is read by a person before it counts.

Does it read complaint or post-market records?

No. Where a dossier asks for post-market history, the complaint handling team supplies one signed document, which appears as a signed input the agents do not read.

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Start with one core file
and the licenses it feeds.

We will build your country grid and show which licenses your next change reaches.

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