AP18 Minimum Information For Reliance MD v4

Strategy to facilitate for medical devices, including IVDs
SEARN Work Plan 2023-2024 – Action point 18
Minimum information required for reliance for medical devices
One of the main objectives of SEARN is reliance. To address this need, the Assembly adopted on 27 July
2023 a Strategy to facilitate reliance. To address this need for medical devices, the Assembly of SEARN
adopted on 27 July 2023 as part of the 2023-2024 work plan an action point to ‘Facilitate reliance for
medical devices, including IVDs’.
This document was developed to support the implementation of this strategy. There would be 2 main
usages of this information:
• Recommendations to guide relying countries on what is required as a minimum for them to be

able to rely on other organizations.
• Recommendations to SEARN countries on what to publish/make available (in relation with AP3
information sharing and AP4 internal platform) in order to facilitate reliance from other
countries on their own decisions.
Acknowledging that the implementation of these recommendations may require addressing practical
and technical challenges, and in some cases further discussions and agreement of other authorities, the
adoption by the Assembly of SEARN will be followed by an implementation period of two years.
Effective communication between reference authority, applicant and NRAs is also required to ensure
that the sameness of the product is maintained after approval. The sharing of some information may
require a Memorandum of Understanding and/or a Confidential Disclosure Agreement.
The information identified in the below table intends to present the minimum information required
for reliance. The below minimum information would generally be expected for higher risk medical
devices and would not usually be required for low-risk medical devices. For reliance, the ultimate
requirement is that the relying NRA should have sufficient trust in the reference authority to use the
output of their work in their own regulatory decision-making system. Abridged assessment may
require additional information.
Regulatory Minimum information required for reliance

function
Marketing The following information should be accessible from the reference

authorizations organization (publicly, or shared by the NRA, e.g. upon request):
1. Evidence of approval from the reference organization with sufficient
details (in one or several documents)
2. Device product name, Product code or model number, unique device
identifier (UDI) (if applicable)
SEARN WG5 – Action Point 18 – Reliance Medical Devices Page 1 of 3

3. Intended use / indications for use
4. Date of approval by the reference organization
5. Marketing authorization number from the reference organization (if
applicable)
In addition, the following information is also required but would generally be

accessed through the applicant:
6. Declaration of sameness of the product: sameness of the intended
use, intended population, intended environment, users,
manufacturing sites and legal manufacturer, regulatory version, codes,
variants and configurations etc.
7. As far as possible, full unredacted assessment reports (performance
evaluation reports for IVDs) from the reference authority where the
product is registered, or if the applicant cannot obtain full, unredacted
assessment reports, the Letter of access may be necessary
8. Quality Management System certificate (e.g., ISO 13485) – please
refer to the RI section
9. Name and complete address (including specific unit/blocks) of the
finished device manufacturer
10. Manufacturer’s declarations of conformity
11. Description (visual appearance)
12. Specifications for the finished product
13. Manufacturer post-market surveillance evaluation (e.g. total product
lifecycle check: recalls, complaints, ..., notice letters)
14. Particular issues: sterilization processes, re-processing, accessories
15. Biocompatibility
16. Performance studies for in vitro diagnostic medical devices (Bench,
Animal, Clinical)
17. Stability summary and conclusions (including the storage statement
and shelf-life)
18. Labelling (including package labels, instructions for use, user manuals,
advertising materials, etc.)
The above information may also be accessed through requesting for the full
technical dossier, similar to the technical dossier that was submitted to the
reference regulatory authority.
Regulatory The following information should be accessible from the reference NRA
Inspections (publicly, or shared by the NRA, e.g. upon request):
1. List of approved manufacturers of finished products (or other sites

involved, such as critical components manufacturer), including name and
address, date of approval and validity
The following information is required and would generally be accessed

through the applicant:

1. List of sites of manufacturers of the finished medical device or IVD,
including the site addresses of the suppliers of the critical materials as
well as the site addresses of all of the suppliers of the semi-finished
medical device or IVD
2. QMS certificates listing all the sites involved in the manufacture of the
product as per ISO 13485
3. Certificate from the reference authority/institution (e.g. WHO
PQ)/Notifying bodies, including:
a. Certificate number
b. Applicable standards
c. Site name(s) and address(es)
d. Issue date and validity
e. Scope: product
4. As far as possible, the latest full unredacted on-site inspection
report(s) (or equivalent, e.g. MDSAP audit report). If non-conformities
were raised, CAPA with evidence of effective implementation should
be requested.
References:
 List of MDSAP auditing organizations

https://www.fda.gov/medical-devices/medical-device-single-audit-
program-mdsap/auditing-organization-availability-conduct-mdsap-
audits
 MDSAP Regulatory Authority Contact Information
https://www.fda.gov/medical-devices/medical-device-single-
audit-program-mdsap/mdsap-regulatory-authority-contact-
information
 WHO Public Inspection Reports (WHOPIRs) In Vitro Diagnostics
https://extranet.who.int/prequal/inspection-services/prequalification-
reports/whopirs-vitro-diagnostics
 List of Notifying Bodies
https://webgate.ec.europa.eu/single-market-compliance-
space/#/notified-bodies/free-search

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Strategy to facilitate for medical devices, including IVDs

SEARN Work Plan 2023-2024 – Action point 18

Minimum information required for reliance for medical devices

• Recommendations to guide relying countries on what is required as a minimum for them to be

Regulatory Minimum information required for reliance

Marketing The following information should be accessible from the reference

SEARN WG5 – Action Point 18 – Reliance Medical Devices Page 1 of 3

In addition, the following information is also required but would generally be

1. List of approved manufacturers of finished products (or other sites

The following information is required and would generally be accessed

SEARN WG5 – Action Point 18 – Reliance Medical Devices Page 2 of 3

 List of MDSAP auditing organizations

SEARN WG5 – Action Point 18 – Reliance Medical Devices Page 3 of 3

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