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More Pre-Development Medtech Work Must Be In Singapore’s Sights

 
• By Ashley Yeo

Singapore is already deeply involved in “commercial” regulatory affairs, but it has the potential to increase the volume of “technical” RA work done locally. So says regulatory professional Jing Lim, who explained these definitions to Medtech Insight.

regulatory compliance concept on the gearwheels, 3D rendering

The ASEAN countries, including the regional medtech regulatory hub Singapore, are not yet known globally for medtech innovation manufacturing. While the region does much manufacturing under contract, when it comes to manufacturers as product owners, local examples are few and far between in the ASEAN markets, compared with Europe and the US.

RA And Regulatorism

Typically, successful commercial RA work is aimed at securing rapid file submission and engaging in efficient follow-up ahead of product registration and approval. This is the role of most country RA experts working in multinational companies, says Asia Regulatory Professional Association (ARPA) founder Jack Wong, an early advocate of the concept of "technical RA" and proponent of “regulatorism.” (Also see "‘Regulatorism': A New Terminology For Medtech And Pharmaceutical Leadership Mindsets" - In Vivo, 2 March, 2020.)

That is something that could change, says Jing Lim, chief technology officer at the Singapore regenerative bone products innovator

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