Couverture de Unlocking Indonesia: Your MedTech Entry Strategy

Unlocking Indonesia: Your MedTech Entry Strategy

Unlocking Indonesia: Your MedTech Entry Strategy

Écouter gratuitement

Voir les détails

À propos de cette écoute

 This episode delves into the critical factors for introducing medical devices to the Indonesian market. We cover the regulatory framework, including the role of the Ministry of Health and the necessity of a Local Authorized Representative. We also discuss device classification, licensing, extensive documentation requirements like ISO 13485 and CSDT, labeling in Bahasa Indonesia/English, the new Halal certification mandate from January 2023, import restrictions, taxes, post-market surveillance, and license validity. Practical advice is offered to help manufacturers navigate this complex landscape. Key Questions: • What is the role of Indonesia's NADFC/BPOM in medical device registration? • Why is a Local Authorized Representative essential for foreign manufacturers in Indonesia? • How does device classification (Class A-D) impact your market entry strategy? • What are the key documents needed for the CSDT dossier, including ISO 13485? • What are the language and labeling requirements for medical devices in Indonesia? • Is Halal certification now mandatory for medical devices in Indonesia, and since when? • What import restrictions and taxes should manufacturers anticipate? • What are the post-market surveillance obligations in Indonesia? • How long are medical device licenses valid in Indonesia and what's the renewal process? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
Les membres Amazon Prime bénéficient automatiquement de 2 livres audio offerts chez Audible.

Vous êtes membre Amazon Prime ?

Bénéficiez automatiquement de 2 livres audio offerts.
Bonne écoute !

    Ce que les auditeurs disent de Unlocking Indonesia: Your MedTech Entry Strategy

    Moyenne des évaluations utilisateurs. Seuls les utilisateurs ayant écouté le titre peuvent laisser une évaluation.

    Commentaires - Veuillez sélectionner les onglets ci-dessous pour changer la provenance des commentaires.

    Commentaires Audible.fr

    Commentaires Amazon
    Il n'y a pas encore de critique disponible pour ce titre.