Regulatory Applications in EU, US, CA and Israel
We can review or originate a variety of regulatory applications. We cover all aspects of a regulatory application, including: guidance and practical assistance with the preparation of the application, handling of the submission process, liaising with regulatory bodies to obtain regulatory approval.
Regulatory Applications of all kinds
BIOREG can prepare a variety of regulatory documents including:
- Premarket notifications – 510(k)
- Pre-sub meeting packages
- Premarket approval applications – PMA
- Request for designations
- Technical Files (Class I, IIa and IIb)
- Design dossiers (Class III)
- Mobile medical applications – assessments
- General wellness low risk devices – assessments
- Natural Health Product submissions
- Homeopathic registration submissions
- 505(b)(2) new drug applications
- Orphan designations
- Orphan drug applications
- Veterinary medicinal product dossiers
- Scientific Advice (EMA) packages
CE Marking Approval for Medical Devices in Europe
The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives in the EU.
In order to obtain CE certification, you must identify the appropriate conformity assessment route for your product. This dictates the required activities to demonstrate conformity.
BioReg will review the route you chose to confirm its suitability, as well as technical documentation required according to the class of your product.
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.
What are General Wellness Low Risk Devices in FDA?
FDA defines general wellness products as products that are intended for the general wellness use and present a very low risk to the users’ safety.
In order to qualify as low risk, the product must not be:
- involve an intervention or technology that may pose a risk to users’ safety (such as lasers, radiation exposure, or implants);
- raise novel questions of usability; or
- raise questions of biocompatibility.
FDA proclaims that it does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements and implementing regulations such as:
- registration and listing and premarket notification requirements;
- labeling requirements;
- GMP requirements and
- Medical Device Reporting requirements.
In a nutshell – low risk general wellness products are basically “regulation-free”.
We will help you to regulate your product as a low risk wellness product and propose appropriate labelling.
Natural Health Product submissions (Health Canada)
Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health.
They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.
Natural health products, often called “complementary” or “alternative” medicines, include:
- vitamins and minerals,
- herbal remedies,
- homeopathic medicines,
- traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines probiotics other products like amino acids and essential fatty acids.
We’re here to register your Natural Health Product in Canada.
Get in touch with us to inquire about the Regulatory Applications we can prepare!