By Ames Gross, Pacific Bridge Medical
Indonesia has introduced updates to its electronic registration platform for medical devices, in preparation for its integration with the regulatory system of the Association of Southeast Asian Nations (ASEAN) in January 2015. It has also clarified rules for customs integration and declaring medical device accessories and spare parts.
Since January 2013, medical device manufacturers and distributors have been able to apply for production and distribution licenses and register products in Indonesia through the country’s online portal.
That portal is now integrated with Indonesian customs through the Indonesia Nasional Single Window (INSW) database. Information such as the name of a product, its registration number, tax number, HS code number and country of origin are all transmitted to the INSW. This allows for the faster release of cargo or the re-export of medical devices.
In addition to the two databases, Indonesia has also set up an online pricing catalog for medical devices. The prices of all medical devices sold in Indonesia will go into the catalogue, which will then serve as a method of controlling medical device prices, according to a spokesperson for Indonesia’s Ministry of Health (MOH).
The spokesperson also clarified rules for declaring medical device accessories and spare parts. Such accessories do not need to be registered as separate products, but must be included as an attachment to the product registration of the associated medical device. If a new accessory or spare part is addedafter the medical device is registered, manufacturers must notify the MOH and allow one month for processing before the accessory or spare part may be sold with the original product.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at email@example.com.