Apakah keperluan dokumentasi yang membolehkan permohonan Surat Sokongan produk kombinasi ubat-peranti perubatan layak di bawah laluan penilaian ringkas? | What are the documentation requirements that qualify an Endorsment Letter application for drug-medical device combination product to be eligible under the abridged evaluation route?

Dokumen yang diperlukan untuk permohonan agar layak di bawah laluan penilaian ringkas adalah seperti yang digambarkan dalam Table 3: Recognised regulatory agencies approval / clearance yang terdapat di dalam Guideline For Drug-Medical Device And Medical Device-Drug Combination Products.

 

The documents that qualify for the application to be eligible under the abridged evaluation route are as depicted in Table 3: Recognised regulatory agencies approval / clearance of the Guideline For Drug-Medical Device And Medical Device-Drug Combination Products.