MEDICAL DEVICE REGULATION IN INDONESIA
Medical devices are regulated by the Ministry of Health (MOH) in Indonesia whose objective is to increase the availability, distribution, and affordability of medical devices. They also help to ensure its safety, efficacy, benefits, and quality. Medical devices are regulated under INDONESIA MOH Decree – 1190/2010.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN INDONESIA
The application for the marketing license of Medical Device importation is submitted by:
The Medical Devices Distributor (PAK) that is in possession of the license from the company or business representative and also has the power as a sole agent acknowledged by the local representative of the Republic of Indonesia, with the appointment term of minimum 2 years;
The Medical Devices Distributor that is a non-sole agent should also possess the power of attorney so as to register the medical device from the medical device production company or from the responsible company overseas; or
The company that is in possession of the production certificate to carry out the reassembling/repacking of imported products.
As per the regulation, the medical devices are classified as Class I, IIa, IIb and III (similar to the term used in Europe MDD). Class A, B, C and D (similar to ASEAN MDD is also adapted in the application form).
The documentation requirements incorporate the elements of ASEAN Common Submission Dossier Template (CSDT), administrative legalization documents, and also some test reports to be verified. There are specific requirements in the test report that requires the manufacturers to comply with to meet the evaluation requirements for the product approval in Indonesia.
ASEAN / Asia REP
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.