MD 41 is the application form submitted to the State Licensing Authority to request approval for wholesale distribution of medical devices under MDR 2017.
MD 41 is the application form submitted to the State Licensing Authority to request approval for wholesale distribution of medical devices under MDR 2017.
MD 42 is the final wholesale license issued after MD 41 is approved. It authorises a business to sell, stock, and distribute medical devices legally.
Any distributor, trader, importer, hospital supplier, or online seller dealing in medical devices must obtain the MD 42 wholesale license.
Yes. Businesses handling Class A, B, C, or D medical devices must apply via MD 41 and receive approval through MD 42.
Yes, every applicant must appoint qualified technical staff responsible for compliance and storage oversight.
Most approvals take 30–90 days, depending on documentation quality and inspection timelines.
It remains valid indefinitely with timely payment of retention fees and continued compliance.
Authorities may seize stock, impose penalties, or restrict the business during audits and tenders.
Yes, MD 42 can include Class A, B, C, and D devices if the premises and CTS meet requirements.
Silvereye Certifications provides complete support—from documentation and classification to inspection preparation—making the MD 41 and MD 42 license process faster, accurate, and compliant.