What is BfArM ?

What is BfArM

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health.

The BfArM is a departmental research institute of the German Federal Government which conducts its own as well as independent research in order to fulfil its tasks pursuant to Section 4 sub-section 3 BGA successor legislation. The BfArM’s tasks serve both public health as well as the safety of medicinal products, narcotics and medical devices.

The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines is responsible for the medicinal products listed below (pursuant to Section 77 AMG [Arzneimittelgesetz, German Medicines Act]).

Official Duties includes :
Authorisation of clinical trials for human use
Processing of applications for marketing authorisations and subsequent applications  in the various national and European procedures
Inspections
Reports relating to blood and tissue products
Advice for national, European, and international target groups concerning the assessment of risks and the development of guidelines
Advice to applicants of marketing authorisations and clinical trials in scientific and procedural questions
Information for patients and consumers

BfArM_Antigen-Test.jpg
Antigen-Rapid-Test

SARS-CoV-2 Antigen Tests Kit

Antigen Tests Kit for the detection of SARS-CoV-2 is an In-Vitro Diagnostics medical device. There are two major type of antigen test kits for the detection of SARS-CoV-2.

1) antigen test kits for professional use

2) antigen test kits for layman

Application for BfArM 

(Antigen Test kits for professional use)

  1. Prepare product information
    1. Description of the product
    2. Instructions for use in German language
    3. Proof of analytical sensitivity (>80% ) and specificity (>97%)
    4. Performance evaluation test (at least 100 RT-PCR positive and at least 100 RT-PCR negative specimens)
    5. Results of stability tests
    6. Technical File
  2. Prepare essential documents for CE Registration of Test Kit for the detection of SARS-CoV-2
  3. Liaise with EU Representative
  4. Apply BfArM application

Application for BfArM 

(Antigen test kits for layman use)

  1. Prepare Product information
    1. Instructions for use in German language intended for self-administration
    2. Repackaging of the product for self-testing
    3. Usability study according to IEC 62366
    4. Proof of compliance with the essential requirements specified in Annex I No. 7 of Directive 98/79/EC
    5. Updated Risk analysis
    6. Technical File
  2. Apply conformity assessment of Test Kit for the detection of SARS-CoV-2 with Notified Body
  3. Liaise with EU Representative
  4. Apply BfArM application
  5. Go through Paul-Ehrlich-Institute Positive evaluation of the product for professional users by the (PEI) and fulfillment of the current minimum criteria of the Paul-Ehrlich-Institute (PEI)

Call BfArM Consultant Now !

Feature

Saving Time & Money

No Hidden Cost

UK Office Support

Different Time Zone

Precise Training

Professional Guidance

Simple BfArM Listing

Low Workload

Contact Us

Frequently Asked Questions

Self Testing Kit : around 6 -8 weeks

For Professional Use : around 5-6 weeks

Our Consultancy Fee does not include Official BfArM Fee

Our Consultancy Service includes preparation of Technical File, Risk Analysis, Product Description, Use of Labelling and EU Representative and arrangement of BfArM application.


Scroll to Top