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REGULATORY UPDATE | Revamped e-Catalog for Indonesian Medical Devices
The Ministry of Health of the Republic of Indonesia has implemented structural and procedural changes to the e-catalog, specifically the sectoral e-catalog, aimed at improving access to medical devices. This initiative is outlined in document KN.01.04/3/630/2022. The Minister of Health has set a target for 20,000 products to be included in the e-catalog by June 2022, in support of presidential reforms.
For the 2022 sectoral catalog registration, 1,482 categories for medical devices, 88 categories for health support equipment, and 1 category for household medical devices have been opened.
One significant change is that all document reviews will now be conducted by staff from the Ministry of Health rather than by the National Public Procurement Agency (LKPP). Users can still access the portal through the existing website: https://e-katalog.lkpp.go.id. The changes have been simplified, with clear designations for 'Sectoral,' 'National,' and 'Local.'
Another key update is regarding pricing. Producers can now set their own product prices without the need for negotiations through the LKPP or the Ministry of Health. This shift aims to alleviate concerns applicants had about price negotiations, allowing them full control over their product pricing.
The sectoral catalog will be open for registration from February 11, 2022, to November 2, 2022.
Source: e-katalog.lkpp.go.id
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Our Services
- License Representative
- Product Registration
- Medical Device Company Establishment Service
- Renewal and License Amendment
- Miscellaneous Certificates
- Post-Marketing Surveillance
- E- Catalogue
- Medical Device Trademark Management
- GDPMD (Good Distribution Practice for Medical Device)
- Regulatory Intelligence
- IDAK (Izin Distributor Alat Kesehatan)