Guidelines

Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements

Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements (MDS-G024)

Guidance for Medication Error Reporting

Guidance for Naming of Medicinal Products

Guidance for Orphan Drug Designation

Guidance for Paracetamol-Containing Oral Liquid Dosage Forms Products Intended for Pediatrics

Guidance for Presenting PIL and Labeling Information of Herbal and Health Products

Guidance for Presenting the Labeling Information, SPC and PIL

Guidance for Priority Review of Product Registration

Guidance for Requirements of Surgical and Medical Examination Gloves - Recognized Standards (MDS – G004)

Guidance for sterile single-use hypodermic syringes - recognized standards requirements (MDS – G005)

Guidance for Submission