IDN/129
WTO/TBT
ID Indonésie
  • 11 - Technologies de la santé
  • 70 - Verre et ouvrages en verre
2021-04-12
2021-02-12

Ampoules Made of Glass for Injection (HS Ex.7010.10.00); Vials Made of Glass for Injection (HS Ex.7010.90.40); Transfusion, Infusion And Injection Equipment (ICS 11.040.20)

Draft Decree of Minister of Industry on Mandatory Implementation of Indonesian National Standard for Ampoules and Vials Made of Glass for Injection (29 page(s), in Indonesian)

This draft of decree states that all of glass ampoules and vials for injection product produced nationally or imported, distributed, and marketed in the country shall conform to SNI requirements. Conformance SNI requirements are proved by having product certificate for using SNI Marking (SPPT-SNI).

The product certificate on SNI marking shall be issued by a Product Certification Body which has been accredited by KAN and appointed by the Minister of Industry.

Directorate of Cement, Ceramic and Processing of Non-metal Material Industry, Ministry of Industry is the responsible institution for the implementation of this decree and shall provide a technical guidance of the decree, which covers procedure of Product Certification and SNI Marking.

Products which are distributed in domestic market that originated domestically and imported shall meet the requirements in:

·         SNI 8823:2019 Ampoules Made of Glass for Injection – Safety requirements which specifies term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian).

·        SNI 4082:2019 Vials Made of Glass for Injection – Safety requirements which specifies term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian).