What is a Health Authority (HA)?

A Health Authority (HA) is an administrative organization or agency designated by a government or an institution to oversee and regulate specific health-related activities and to enforce health policies and standards. Health authorities’ responsibilities involve public health protection, the regulation of healthcare providers and facilities the oversight of medicines and medical devices, and the management of healthcare services within a certain jurisdiction. They may also be involved in health promotion, disease prevention, and emergency preparedness and response.

Examples of global Health Authorities includes:

1. United States: Food and Drug Administration (FDA).
2. European Union: European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG Grow).
3. Canada: Health Canada.
4. Brazil: National Health Surveillance Agency (ANVISA).
5. Japan: Ministry of Health, Labour, and Welfare; Pharmaceuticals and Medical Devices Agency (PMDA).
6. Australia: Therapeutic Goods Administration (TGA).
7. China: China Food and Drug Administration (CFDA).
8. Singapore: Health Sciences Authority (HSA).
9. New Zealand: New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE).
10. Switzerland: Swissmedic.
11. United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA).
12. France: National Agency for the Safety of Medicines and Health Products (ANSM).
13. Ireland: Health Products Regulatory Authority (HPRA).
14. Netherlands: Dutch Healthcare Authority (NZa).
15. Denmark: Danish Medicines Agency.
16. Belgium: Federal Agency for Medicines and Health Products (FAMHP).
17. Zimbabwe: Medicines Control Authority of Zimbabwe (MCAZ).
18. India: Central Drugs Standard Control Organization (CDSCO).

What is a Notified Body (NB)?

A Notified Body (NB) is an independent entity designated by the EU Member States to assess if products like medical devices meet specific standards. They perform activities such as testing and certification, especially for high-risk devices before market placement. Manufacturers must seek assessments from the NBs for certain risk classes. These bodies are monitored by national authorities to ensure impartiality and are listed in the European Commission's New Approach Notified and Designated Organisations (NANDO) database. They are crucial for the conformity assessment of medical devices under the EU regulations 2017/745 and 2017/746, and their designation and operation are subject to strict criteria to maintain objectivity and avoid conflicts of interest.

As part of CE marking, manufacturers submit the technical documentation of the device to the appropriate designated NB. The NB may have queries on the details submitted in the documentation which manufacturers have to respond to with suitable technical updates made to the documents.

At Freyr, we are equipped to communicate and address the HAs and NBs queries in over 120 countries for over 250 unique service offerings. Our commitment to deliver accurate and tailor-made services ensure a seamless journey towards Regulatory compliance.