Tag Archive for: Archive

Know Your Market Price in Japan

Japan should be the second largest national market for your medical device after the United States and maximizing sales performance in Japan should be critical to your overall corporate success. Yet, many manufacturers are frustrated by their results in Japan or struggle to attract the interest of leading distributors. Follow these steps to create a winning market strategy in Japan that will wow investors and leapfrog the competition.

India Moves to Online Application Submission System for Medical Device Registration

The Drugs Controller General of India (DCGI) announced on May 1, 2016 that the SUGAM online application submission system, in use since November 2015 for pharmaceutical registration, would be extended to medical device and IVD device submissions (e.g., registration and import license applications).

Increase in Independent License Holder Option in India

More companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.

Ablation Devices Now Require Registration in India

The India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.

Thailand to Implement New Medical Device Classification System

The Thai Food and Drug Administration (FDA) has announced its intentions to implement a risk-based medical and IVD device classification system toward harmonization with ASEAN MDD guidelines.

New Office Space for Asia Actual India

Asia Actual is excited to announce the dedication of our new office space in the Delhi area.  

Medical Device Pricing Controls May Be Coming to India

The National Pharmaceutical Pricing Authority (NPPA) in India is considering applying the Drug Price Control Order (DPCO) to medical devices. Importers of notified cardiovascular and orthopedic devices have been put on notice to control mark ups, or the NPPA will intercede. If so, limits will be applied to the difference between landed cost and the Maximum Retail Price (MRP) anticipated to be around 35%.

Medical Device Re-Registration in Hong Kong

A large number of medical device listings in Hong Kong are coming to the end of their 5-year validity period and must undergo a re-registration process in order to maintain an active Medical Device Listing.

India Publishes New Medical Device Regulations

On July 12, the Ministry of Health and Family Welfare published a draft of new medical device regulations (Medical Device Rules, 2016) which will require registration for all medium to high risk medical and IVD devices. Implementation could happen as early as year end.

Philippines FDA Moves to Streamline Submission Systems for Device Registration and Licensing

This month, the Center for Device Regulation, Radiological Health and Research (CDRRHR) has relocated from the Department of Health in Manila to new facilities within the FDA central compound in Alabang.