The MDRC is working with the Ministry of Health and industry stakeholders and has identified the following MDRC priority areas of work in Indonesia:

Good Regulatory Practices – Implementation and Operationalization
Use of international standards and conformity assessment as essential GRP
Medical Device Regulatory Convergence, Reliance and Recognition

MDRC Outputs

Analysis and comparison of the Indonesian MOH medical device regulatory SOP to international GRP benchmarks

This analysis provides recommendations for the Indonesian MOH to align its SOP with the five common phases regarding GRP: Regulatory Agenda, Regulatory Impact Analysis, Regulation phase, Ex post Evaluation, and finally Public Consultation.

Checklists of Good Regulatory Practices (GRP) on technical regulations and conformity assessment procedures requirements for ideal inclusion within the Indonesia MOH Regulatory SOP and framework

These provide a solid preparation of the technical regulations, based on World Trade Organization rules, international standards and references, as well as provide questions related to transparency, public participation, impact assessment analysis, elaboration, and publication of the technical regulations to control compliance during the regulatory process.

Summary of recommendations for inclusion of GRP elements within the MOH implementation of the Omnibus Health Law

These recommendations allude to specific articles of the Omnibus Health Law related to medical devices, and provide for the possibility of improving and developing the domestic regulation towards the implementation of and compliance with Good Regulatory Practices (GRP).