This new draft is a derivative of the Presidential Regulation No. 28 Year 2024 and contains 282 articles which regulates the health supplies. It defines that Health Supplies are all materials and equipment necessary for Health Efforts such as Pharmaceutical Preparations, Medical Devices, and other Health Supplies according to the needs. The scope of this regulation includes the Product Import and Export, Good Distribution Practice, Clinical Test, Production, Distribution, Vigilance, Post-Market, Priority to Use Local Production and certain policies related to Medical Devices.
In Chapter X of the Closing Provisions, article 281, states that several Regulations of the Minister of Health such as Minister of Health Regulations No. 1189 Year 2010, No. 1191 Year 2010, No. 4 Year 2014, No. 51 Year 2014, No. 62 Year 2017, No. 63 Year 2017, No. 60 Year 2017, and No. 7 Year 2020 will be revoked and declared as invalid.
This draft regulation is a combination of a repetition of existing regulations and other related updates. Below are the highlighted information that might impact Andaman clients:
1. Article 69
To increase the use of domestic Pharmaceutical Preparations and Medical Devices, the substitution of Pharmaceutical Preparations in the form of imported Drugs and Medical Devices with domestic Drugs and Medical Devices will be carried out. “Freeze and Unfreeze” method to prioritize the local produced medical devices will be stipulated in this regulation.
2. Articles 201 – 219: Sampling and Testing
Sampling and testing of Medical Devices and Household Health Supplies are carried out to ensure the conformity of quality and safety of products in circulation. The list of certain medical devices that are required to be tested and/or calibrated will be provided in the Appendixes of this regulation. However, the appendix was not released in this draft yet.
3. Articles 221 – 228: Vigilance
Vigilance is carried out to protect the health and safety of Medical Devices and Household Health Supplies users by minimizing the impact of Unwanted Events and preventing similar Unwanted Events from recurring. Periodic Safety Update Report (PSUR) aims to strengthen the effectiveness of vigilance activities carried out by the license holders and should be reported periodically through a health information system that is integrated with the National Health Information System. PSUR for Class Risk B and Implant Medical Devices shall be done every 2 years, and for Class Risk C and D a minimum of once a year. Information that can be reported on PSUR could be Adverse Event and CAPA, Vigilance trend, any information gathered from user, distributor, or importer, and provided information for the public pertaining to similar medical devices. Further provisions for these post-market activities will be provided in the Appendix. Similar as Point (2), the draft of the appendix was not provided yet.
Further information of this regulation can be accessed here (in Bahasa Indonesia, English Translation is not available).
Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.