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Philippines Releases US$9M To Hospitals For COVID-19 Response

The PCSO is a major source of funding for new hospital construction and medical device and equipment purchases and is often overlooked by outside suppliers. Medical device manufacturers should discuss with their Philippines distributors about what opportunities are available through the PCSO.

South Korea Releases Guidance for Software using Big Data, AI, and Machine Learning

The South Korean regulator, the Ministry of Food and Drug Safety (MDFS), recently released multiple guidance documents related to software using AI, Big Data and Machine Learning.

Philippines Proposes New Fees for Medical Device Registration

The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D. 

Indonesia Market Summary and Registered Devices Review

In recent years, the government has made healthcare a priority for the 261 million Indonesians, providing a lot of potential for medical device manufacturers of all technology levels. The government has also taken numerous steps to curb corruption through their online e-catalogue and other methods which has helped bring in more foreign companies and investment.

Voluntary Medical Device Registration in Hong Kong

Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.

Update: India To Require Local Certification of All Power Cords

With effect from December 1, 2020, India power cords, cord sets, plugs and sockets must carry the Mark of Conformity (product approval mark) which has been established by the Central Government of India through the Bureau of Indian Standards (BIS) Act (2016), BIS Rules 2018, and BIS Conformity Assessment Regulations (2018).

INDONESIA E-CATALOGUE MEDICAL DEVICE ENROLLMENT 2020

Medical device manufacturers are advised to prepare e-Catalogue applications early and be vigilant for the enrollment announcement. Implementing an optimal pricing strategy will be critical to successful public hospital sales. ​The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is little room for regional dealer margin under the price scheme.

ARTIFICIAL INTELLIGENCE (AI) SOFTWARE REGISTRATION IN SINGAPORE

In December 2019, the Health Sciences Authority (HSA) of Singapore’s Ministry of Health released guidelines regarding software registration in Singapore, including a major section dedicated to AI software.

U.S. Medical Device Industry – Open for Business

Uncertainty.  If there is one word that best describes the global outlook during the 2020 pandemic this might be one that everyone can agree on. 

VIETNAM: HIGH GROWTH FAST MARKET ACCESS

Vietnam has been quietly transforming their economy of 100 million people into a regional powerhouse. Through a combination of significant private investment, the US-China trade war, and their highly successful handling of the Coronavirus, Vietnam’s economy is expected to rebound quickly, especially with regards to manufacturing.