The South East Asia Medical Device markets including Korea, Indonesia, Thailand, Malaysia, India, Philippines, Singapore, Malaysia and Vietnam have been growing at a higher rate than the developed medical device markets of the Western world. These countries have shown high rate of imports in medical devices, larger expenditure by the private and government sectors and increasing interest in medical device manufacturing. Demands for import and infrastructure in the medical device market in South Korea, Indonesia, Thailand, Malaysia, India, Philippines, Singapore, Malaysia and Vietnam is mainly due to the expansion in the healthcare sectors and increasing priority of the governments to provide high quality of care to its people.

The Indian medical device industry is also primarily run on imports. About 85% of medical devices are imported into the country. In order to address this issue, the Indian Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) conducted a series of meetings to understand the challenges for medical device manufacturers in India and how best to address them. Discussions included the registration of medical devices, IVDs, cosmetics and drugs in India.

Key points discussed include:

• Re-visiting and implementing the Schedule MIII, which is the draft guidance on good manufacturing practices and facility requirements
• Systems for export labeling
• Clarification for clinical evaluation and adverse reporting
• Free Sale Certificate: Manufacturers often require this certificate to export medical devices . It has been agreed that the state licensing authorities extend the Free Sale Certificate validity from 2 years to 5 years to allow manufacturers to export.
• Online Database: to make the list of companies howling export license easily accessible by different regulatory authorities world wide.