Introduction
The client is a global publicly traded company that manufactures various lines of disposable products. Product in question was a device that was being manufactured and packaged in kits in the UK along with a drug (purchased by a UK company). The client wanted to move the manufacturing from the UK to Malaysia. The kits would be assembled in Malaysia as well along with the drug and would be for export only. The kits would not be sold in Malaysia.

Business Challenge

Client’s overall objective was to understand the impact of moving manufacturing facility from Europe to Asia on import/export requirements. The critical business decision of moving manufacturing facility would be based on the results. One of the big concerns was whether the drug which was being piggybacked on the device would need to be registered in Malaysia. The drug was imported into Malaysia to be assembled into kits. The client had no intention of distributing the drug in the Malaysian market. Drug registration and approval would take over a year. The client also needed to understand the requirements imposed by the Regulatory Authorities in both Malaysia and UK.

Solution
RegDesk utilized expert-sourced intelligence to gather the opinions of multiple thought leaders in both Germany & Malaysia. Specifically, six experts were engaged to investigate the import/export implications as well as regulatory requirements in each country as they pertained to the client’s product and situation. This gave our client access not only to the information but to the validity of the information they received as it came from multiple yet independent sources.

Results

Through RegDesk, the client was able to determine that the drug component of client’s kit was indeed, required to be registered in the country, yet the medical device portion of the product did not need to be registered. RegDesk was also able to provide comprehensive intelligence on the EU & subsequent Malaysian export requirements for the kits. The client has since made RegDesk their go-to platform for regulatory intelligence and insights.

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co.