REGULATION ON MEDICAL EQUIPMENT AND HOUSEHOLD MEDICAL SUPPLIES

SNI Certification for Medical Equipment will be Mandatory at 2013.

The Minister of Health on 23 August 2010 issued Regulation No. 1189/MENKES/PER/VIII/2010 regarding Production of Medical Equipment and Household Medical Supplies (the “Regulation”). The Regulation was issued with a view to adjusting the previous regulation in light of technological development and the need to protect the public from hazardous misuse and abuse of medical equipment and household medical supplies, and to prevent the use of medical equipment and supplies that do not meet quality and safety standards.

The provisions of the Regulation among others regulate the production method, product certification, quality maintenance, export procedures, product withdrawal and disposal, and production monitoring and supervision.

Medical equipment and household medical supplies may only be produced by certified companies, and they must meet the quality, safety and utilization standards of Farmakope Indonesia, the Indonesian National Standard (SNI), or other standards that are approved by the Minister of Health. Medical equipment and household medical supplies that are produced by small scale industries are regulated separately from this Regulation.

Companies that produce, re-package, manufacture, and re-manufacture medical equipment and/or household medical supplies must submit a production report to the Director General of the Ministry of Health at least once a year in the format provided in the attachment of the Regulation, and send a copy of the report to the Head of the Local Provincial Health Agency and to the Head of the Regency/City Health Agency.

The Regulation revokes the previous Minister of Health’s Regulation No. 1184/MenKes/Per/X/2004 on the same subject matter, and became effective on the day of its issue. (by: Hamu)

List of SNI Standard Medical Device Click here