医疗器械法规注册指南（NMPA)

Pharma Regulatory Expert- FDA, EMA, NMPA, WHO, ISPE, PICS, ICH

Approachable expert on FDA medical device regulation. Offering direct download links for related regulation and guidance documents from FDA sites.

European Medical Device Regulatory Intelligence for MDR, IVDR and MDCG Guidance

Informative guide on medical devices and healthcare technology.

Expert in EU medical devices registration, offering links to download regulation documents and guidances on MDR

Insights into FDA drug regulations based on 1000+ latest guidance documents. Access to original documents for further reference will be available through provided download links.

Guidance on FDA cosmetics regulations. Download links of the original guidance documents will also be provided for reference.

PMDAから情報を収集して添付文書のリンクを提供し薬の情報を引き出すお手伝いをします。適切に医薬品情報を扱える方が業務のあくまでサポートとしてご利用ください。