FDA eCopy program
With the term eCopy, the FDA refers to the electronic copy/version of paper-based submissions, e.g., as part of a 510(k) submission.
The international approval of medical devices is a challenge for most manufacturers. This is because the regulatory requirements differ in the various markets.
On this page, you will find links to further information that is helpful for international approval:
Information on the requirements of the markets
The regulatory requirements for approving and monitoring medical devices on the market are similar. But they are not congruent. The following articles provide a quick overview:
- USA / FDA
- Brazil and INMETRO
- China
- Great Britain, Brexit
- Japan
- Russia and the Eurasian Federation
- Saudi Arabia
- South Korea
- Switzerland
- Turkey
Further information
This information is also relevant for international approval:
- 5 steps to new markets
- Dealing with free sales certificates
- Medical Device Single Audit Program (MDSAP)
- CB reports
- Comparison of approval in the EU and the USA
Support
The Johner Institute provides support with international approval. It also acts as an authorized representative in other markets, such as the UK and Switzerland.
Contact us to clarify the next steps to get your devices to all desired markets quickly and safely.
Request for Information: How the FDA is helping with classification
A ‘Request for Information’ can (partially) avoid expensive legal fees. Just ask the authorities directly! This way, you will get a qualified answer, even if it is not free of charge. Read here to find out
DetailsNMPA Usability Guidance: How to fulfill the requirements
The NMPA Usability Guidance affects many manufacturers of medical devices and IVDs, as well as manufacturers of combination products, who want to market their products in China. This article clarifies which devices must comply with the NMPA requirements regarding usability and what these requirements are.
DetailsMDSAP: Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities from different countries with one audit. Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g., with ISO 13485 or 21 CFR part 820). In…
DetailsFDA Pre-Submission Program
With the Pre-Submission Program (“pre-sub” for short), the FDA offers a formal procedure for manufacturers to clarify their regulatory strategy and specific questions before actual approval or market clearance. A pre-sub request is suitable in the preparation of 510(k)s, De Novo Requests, or PMAs, among other things. This can avoid unnecessary costs and effort on…
DetailsThe FDA eSTAR Program: should or must you take part?
With the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. The Johner Institute is working with the FDA on the further development of eStar. This article tells you how forward-looking this approach is and whether you should or even must take part.
DetailsApproval of medical devices in Brazil
It is not easy to get medical devices approved in Brazil. This is due to the number of regulations, their complexity, and the fact that Brazil has published most of the regulations in Portuguese only. This article provides an overview and highlights similarities with the European and US systems. This will make it easier for you…
DetailsDe Novo Program of the FDA
The De Novo request, which the FDA also refers to as the “De Novo program” and the “De Novo submission process”, is one of the approval processes for medical devices in the United States. As the name “De Novo” suggests, manufacturers can use this process for novel products. In other words, manufacturers should submit a…
DetailsOrphan medical devices: Hope for the weakest?
Orphan medical devices are medical devices (and IVDs) for small patient groups. The development of these niche products is often not profitable for manufacturers. As a result, particularly vulnerable groups, such as children, do not always receive adequate medical care. This article shows possible solutions and classifies the guideline MDCG 2024-10.
DetailsWhy you should consider clinical studies in Australia
Conducting clinical studies in Australia is not on the radar of many medical device manufacturers. However, good reasons exist to consider this continent for clinical studies or investigations. Yet manufacturers should also be aware of Australia’s regulatory requirements and specific disadvantages.
