Indonesia Medical Device Update

Author: 
Ames Gross

The Indonesian economy has been strong recently, and its GDP should continue to grow at about 5-7% during the next few years. The economy is bolstered by strong exports and increasing investments. Because of the country’s weak currency and cheap labor costs, Indonesia is an attractive location for device manufacturing. The Indonesian medical device market was worth about $500 million in 2010.

Foreign companies who want to sell their medical devices in Indonesia need to get two licenses, a distributor’s license and a product license, before their products can be imported, sold, and used in Indonesia.

For distribution, foreign companies can set up their own local entities in Indonesia or utilize an Indonesian distributor that has received a medical device distributor’s license from the Ministry of Health (MOH). Application requirements for the distributor’s license include documents such as an inspection report on facilities and an establishment notary document. In addition, the MOH requires the submission of annual reports on distribution and adverse events from the medical device companies or their Indonesian distributors.

Medical device companies apply for product licenses from the MOH after acquiring the distributor’s license. The requirements to apply for a product license for new medical devices include documents such as an application letter to the MOH, a letter of authorization, specifications and quality assurance, labeling and use instructions, etc. Companies should note that re-manufactured, re-conditioned, assembled, or packed products also require product licenses. If all documents are completed and submitted in a timely manner, then the total application process for the product license should take about six months. Medical device product licenses are valid for a maximum of five years but are renewable. On the other hand, the distributor’s license is valid for an indefinite period of time.

Ames Gross is the president and founder of Pacific Bridge Medical. He is recognized nationally and internationally as a leader in Asian medical markets.