Regulatory

Certifications

We manufacture a wide range of products here at Eco-Med Pharmaceutical Inc.! From ultrasound products to first aid, in order to be sold in different regions around the world, we must apply for specific licences and certifications.

Our ultrasound gels are classified as Medical Devices in Canada, the EU and the US, which require site and product licenses.

Our hand sanitizer, rubbing alcohol and hydrogen peroxide products are classified as Natural Health Products in Canada and require an NPN (natural product number) and valid site licence to be legally sold. In the US, these products are considered OTC (over-the-counter) drugs and require us to uphold a Drug Establishment Licence and apply for an NDC (national drug code) to legally be sold in the US.

ISO 13485:2016 is a voluntary quality management program that includes strict requirements regarding our products, facility, employees, and SOPs (standard operating procedures). We undergo annual audits that verify all of our processes and documents are kept up to date and meet the medical standards for Canada, US and the EU. Many companies choose to forego this program due to cost and workload, but we believe this demonstrates our initiative to be a global leader in the industry, and illustrates our commitment to providing you with the best product.

health canada

– Class I Medical Devices
– Natural Health Product Licences
– Site Licence for Natural Health products
– Medical Device Establishment Licence (MDEL)

United States Food and Drug Administration (FDA)

– 510K for Class II Medical Devices
– Over-The-Counter Drugs (OTC-Drugs)
– Drug Establishment Licence (DEL)
– Medical Device Establishment Licence

Conformitè Europëenne Mark (CE Mark)

– Medical Device CE Registration

ISO 13485:2016

– Medical Device

Testing

We have completed rigorous testing on all of our products to ensure you receive a product that is safe to use. This includes shelf-life testing to determine the longevity of our product, biocompatibility testing to confirm our product is not an irritant and microbiological testing to confirm bacteria cannot grow on our product for the duration of its shelf-life. Assay testing is completed on our Hydrogen Peroxide and Rubbing Alcohol products to ensure the concentration of active ingredient is within specifications. We also test that the concentration of heavy metals, and residual solvents are well below allowable values for every batch.

Biocompatibility

– Irritation
– Cytotoxicity
– Sensitization

Shelf-Life

– Accelerated
– Real-Time

Microbiology

– USP 61

Assay Testing

– GC-FID

Heavy Metals Testing

– Arsenic
– Cadmium
– Mercury
– Lead

Residual Solvent Testing

– USP 467

Quality Control

We undergo in-process testing throughout the manufacturing line as well as final product testing to ensure the product and the packaging meets the standards required by the applicable Regulatory bodies. We take samples of every batch made, to confirm viscosity (to measure product thickness), pH (to ensure it is the same pH of skin), specific gravity (density) and microbiological testing (to confirm bacteria counts are within allowable parameters). These tests although rigorous and time-consuming, are why we are confident every batch will surpass your expectations!

We also conduct routine testing of filled product to ensure every bottle, cube or jug you receive has the correct amount of product. We hand pack each product with care and ship our products to hospitals and distributors globally, securely and in a timely manner.

product testing

– pH, Specific Gravity, Viscosity
– Microbiological testing
– Product weight checks
– Barcode verification process

supplier evaluation

– Raw material evaluation
– Supplier audits
– Annual supplier review