The corrective level of skin contour or wrinkles and the time needed for therapy depend on the property of defect site, the tension, depth of tissue and the technique of injection. The correct technique of injection is important for successful treatment. PavéDerm J-Fill Soft Dermal Fill is only intended to be administrated by authorized personnel in accordance with local legislation. Based on preclinical equivalence evaluations with competitor , the estimated efficacy duration of this product is six months.

MOHW-MD-No. 006932

YUNG SHIN PHARM IND. CO., LTD. (MEDICAL DEVICE FACTORY)

I. Process and Equipment Validation

To ensure mass production stability, validation protocols and acceptance criteria are established for manufacturing processes,production equipment, sterilization, and analytical methods. Execution:Validation is performed per approved protocols,including equipment qualification, process validation,sterilization validation, and analytical method validation. Disposition:Samples are analyzed against acceptance criteria. Conforming results complete validation. Non-conforming results trigger product rejection, deviation investigation,and re-validation until compliance is achieved.

II. Finished Product Testing and Transportation Finished products are transferred to the warehouse after inspection.

Sampling & Testing: Conducted per SOPs to confirm specification compliance. Labeling: Packaging and labeling are verified. Disposition: Conforming products are released, recorded in inventory, and retained as retention samples. Non-conforming products are identified, segregated, and subjected to an Out-of-Specification (OOS) investigation and disposition. Transportation Management: Includes distribution records, vehicle management, and transportation quality control.

III. Third-Party Safety Testing Results The product underwent biocompatibility evaluation, including cytotoxicity, sensitization, irritation, and systemic toxicity, by an OECD GLP-compliant third-party laboratory. Results meet ISO 10993 requirements, supporting clinical safety.

The company policy ensures proper supplier selection through capability verification, source control, and written proof of compliance with quality standards. Raw materials are inspected upon receipt under Receipt and Quarantine procedures, and only those meeting specifications and purchase order requirements are accepted for production.

All manufacturing personnel share responsibility for quality. Inspections and tests follow manufacturing instruction, control procedures, and defined product specifications. Final inspectors must confirm completion of prior inspections and tests before performing finished product inspections. Quality Assurance reviews results and authorizes product release through the product release procedure. At each stage—receiving, in-process, and final inspection—accepted or rejected products are clearly identified, and nonconforming items are segregated.

All procedures and staff comply with electronic data integrity and good documentation practices, ensuring complete records and signatures for every inspection and test. Quality management and product realization processes employs statistical techniques for monitoring and measurement. In the event of abnormalities at any stage, deviation management and corrective/preventive measures are immediately applied to trace root causes, address defective products, complete investigations, and implement improvements. This ensures product conformity and enhances the quality of decision-making.

Risk Management System Per the Medical Devices Act, QMS, and Safety Surveillance Regulations, YUNG SHIN PHARMACEUTICAL maintains a robust quality organization and Total Product Life Cycle (TPLC) risk management system.

I. Design Control The Design and Development Procedure serves as a core QMS sub-system, integrating risk management via:

Cross-Functional Team: Dedicated Risk Management Team oversees risk assessment and control throughout R&D.

Initial Control: Initiates Design Input and Risk Management Files (RMF) early to ensure compliance.

Design Review: Management Representative-designated qualified personnel collaborate with R&D on risk assessments (including V&V risk determination) to mitigate hazards and generate Risk Management Reports.

TPLC Monitoring: Implements Phase IV assessment (post-market/post-production info) to dynamically update risk reports.

II. TPLC Risk Control

IQC: Conducts supplier evaluations, sets material acceptance criteria, and performs sampling per SOPs. Non-conforming items are immediately isolated, labeled, and investigated via OOS/deviation protocols.

IPQC: Monitors process parameters with self-checks. Audits environmental particulates/microbials, equipment, and compliance. Anomalies trigger line stoppage and risk impact assessments.

FQC: Executes final release testing. Conforming products are inventoried and retained, utilizing batch control for end-to-end, two-way traceability.

In compliance with the Medical Devices Act and the Regulations for Medical Device Safety Surveillance enacted by the Ministry of Health and Welfare, quality management organization has been established. The Risk Management Team oversees product design and development, formulating risk management documentation to ensure full compliance with design requirements throughout the lifecycle. A qualified professional designated by the Quality Representative, collaborating with the R&D department, conducts risk assessments under the Medical Device Risk Management Plan prior to design reviews to generate the Medical Device Risk Management Report. Post-market risk assessment and analysis, and reports are continually executed per the plan until the end of the product lifecycle. “PAVEDERM J-Fill Soft Dermal Filler” is included in the medical device safety monitoring list, this product has completed all six Periodic Safety Reports and the final Safety Summary Report. Throughout the 3-year surveillance period, no product-related adverse reactions were reported. Safety data from literature collected during this period have been incorporated into the contraindications and side effects of the product insert, alongside precautions in the warnings. Clinical evidence confirms substantial efficacy with rare risks of adverse events or safety concerns, demonstrating high therapeutic value with no unexpected post-market risks.

Ma SH, Wei YH, Lee DD, Chang YT, Chen CC. Efficacy and safety of PavéDerm J-Fill for nasolabial folds: A phase III randomized, blinded, prospective, and split-faced head-to-head trial. Dermatol Ther. 2022 Jun 1.

Taiwan Patent TWI424007B, Patent Title: Method for Crosslinking a Colloid and Crosslinked Colloid Formed Thereby. US Patent US8946305, Patent Title: Method for Crosslinking a Colloid, and Crosslinked Colloid Therefrom.