Device class estimator
Get a reasoned first estimate of your medical device class.
A guided screen for Singapore and Malaysia that separates general medical-device rules from IVD rules, explains the result, and connects it to Everest Nova's fixed dossier pricing.
Class A
Low risk
Often simple, non-invasive, or non-critical products.
Class B
Low–moderate risk
Often active, short-term invasive, or routine diagnostic products.
Class C
Moderate–high risk
Often higher-impact, implantable, critical monitoring, or higher-risk IVD products.
Class D
High risk
Often the most critical implants, direct central-system contact, or highest public-health-risk IVDs.
Rules-based screen
Plain-language questions, with the reasoning shown.
Classification depends on the intended purpose, design, duration, invasiveness, power source, user, result impact, and special-risk characteristics. If more than one rule applies, the highest class generally controls.
No payment is taken from this estimate. Everest Nova confirms the classification, scope, and exact price before Stripe is enabled.
Official guidance used for this screen
The questionnaire is a simplified educational screen based on broad HSA and ASEAN-style classification principles. It does not replace the complete rule sets, regulator guidance, or a product-specific professional review.