ACHIEVEMENTS TO DATE
MOH Approval From the Israeli Ministry of Health, (MOH) for commercial use of the technology.
CE Mark Approval for the EU market operation.
EMC and SAFTY Approval from the Israeli Authorities.
Production Line Establishment Complying with medical standards.
Mutual Research With the Israel’s Ministry of Agriculture (MoAG) which recognized Nova’s potential.
Agreements With few of the largest medical cannabis growers in Israel for pilots and commercial use.
Regulatory requirements
The regulatory and compliance required for our product are divided into product certification, which address the requirements of the actual device to obtain commercialization approval (safety issues), and product qualification, to comply with regulatory standard in each target market in terms of disinfection performance:
Product Certification
IEC (International Electrotechnical Commission)
1. IEC 61010-1:2010 – a safety standard required for electrical equipment aimed for measurement, control, and laboratory use.
2. EMC (Electromagnetic Compatibility) – functional safety testing, to carefully evaluate the product design for Functional Safety failure modes in the presence of EMI.
Product Qualification
Most EU countries now allow, or consider allowing, the medical use of cannabis or cannabinoids of some form. However, the there are a variety of approaches in terms of both the products allowed for use and the regulatory frameworks governing their provision. For example, Dutch regulations demand that medicinal cannabis contains no more than 100 CFU (Colony Forming Units) yeast a mold per gram of final product, which is close to sterility. Under the Canadian program, limits are somewhat higher with a maximum of 10000 CFU total microbial load per gram. According to the European or US Pharmacopoeia standards for inhaled preparations, certain specific pathogens must be completely absent, i.e., Staphylococcus aureus, Pseudomonas aeruginosa and any bile-tolerant Gram-negative bacteria such as E. coli. The absence of fungal mycotoxins must be confirmed by additional quality control testing. National regulatory frameworks are also complicated and sometimes may present lack of clarity regarding both the details of the various approaches and how they are put into practice. In addition, they evolve over time, and experts sometimes disagree on how such frameworks should be interpreted legally. Regulation varies between states, and usually requires the approval of the department responsible for cannabis in the Ministry of Health.
