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).