Pre-approval Services for your product
Choosing BIOREG as your regulatory strategy partner means your product(s) will be brought to the market in a safe, effective and timely manner.
For companies in the pre-approval phase, we counsel on product development, preclinical and clinical trial issues, communications with the FDA and Notified Bodies during the review process and regulatory strategy including premarket notifications (510k), premarket approval applications (PMA), combination products, 505(b)(2) new drug applications and orphan drugs.
- Contact with regulatory authorities
- Contact with EU Authorized Representative
- Pre-submission packages
- Pre-submission meetings
Contact with Regulatory Authorities Worldwide
We work with the major regulatory authorities worldwide:
- EU (CE),
- Health Canada,
- Israel Medical Device Department (AMAR),
- Israel Ministry of Health (Medicinal products),
- Therapeutic Goods Administration (TGA – Australia) and others.
Why the Choice of Your Notified Body Has to be Right?
The role of a Notified Body is to conduct a conformity assessment under the relevant EU Directives. The Notified Body conducts the conformity assessment against the relevant sections of the applicable Directive (MDD, AIMDD or IVDD).
The conformity assessment usually involves an audit of the manufacturer’s quality system and depending upon the particular classification of the device, a review of the relevant technical documentation provided by the manufacturer in support of the safety and performance claims for the device.
It is very important to choose right Notified Body for your product. We will advise you which Notified Body in EU will best serve your interests.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.
REGULATORY PACKAGES FOR STARTUP COMPANIES
We have created several packages for startup companies that will help you in every step of regulation process for your medical device or other medical product.
Why do you need EU Authorized Representative?
If you plan to market your medical device product in Europe, you will need to obtain CE mark first. If your company does not have a physical location in the EU, you are required to appoint an Authorized Representative, to represent your company to European authorities. The role of EU Authorized Representative is to serve as a liaison between you and the national Competent Authorities.
The appointed EU Authorized Representative has other important functions such as to assist you during CE certifications process, review your Technical File documentation for Class I CE self-certified products, assist with Field Safety Corrective Action (FSCA) reporting and many others.
BioReg works with experienced EU Authorized Representatives which focus on regulatory affairs and therefore could be helpful throughout CE review process.
Submission packages for Medical Devices in FDA
Medical devices in FDA are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type.
Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration; Medical Device Listing; Premarket Notification 510(k); unless exempt, or Premarket Approval (PMA); Investigational Device Exemption (IDE) for clinical studies Quality System (QS) regulation; Labeling requirements; and Medical Device Reporting (MDR).
What is 510(k)?
Each person who wants to market medical device in US, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements.
Before marketing a device, each submitter must receive an order from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the US.
This order “clears” the device for commercial distribution. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.
Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.
A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process.
The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate device“.
BIOREG provides regulatory services covering a broad range of technologies to many small and mid-sized companies who are struggling to achieve the fast regulatory approval which will maximize the marketing potential of their product.
Get in touch to find out more about our Pre-Approval services we can provide!