After attending medical exhibitions at home and abroad and cooperating with numerous overseas buyers, we have long understood an unspoken industry rule: when major global purchasers select dressing manufacturers, ISO medical device quality management system certification is always their primary screening standard. Without this qualification, factories will hardly be shortlisted as cooperative suppliers.

For us, ISO 13485 serves as an indispensable compliance pass that enables our medical dressings to enter global markets.

To Wuhan Hangu, the ISO 13485:2016 certificate is far more than a decorative document locked in our exhibition hall display cabinet. It acts as a unified quality benchmark. Whether we cooperate with European and American clients, Middle Eastern distributors, or local private brands of Southeast Asian clinics, both parties can quickly align quality requirements based on this set of standards.

Our product lineup covers hydrocolloid acne patches, scar sheets, microneedle patches, surgical films, tattoo repair films, as well as functional dressings such as transdermal smoking cessation and alcohol cessation patches. We completed the full system audit and obtained the certification on November 7, 2024, with certificate number 381240274R0S.

• Hydrocolloid acne patches
• Scar sheets
• Microneedle patches
• Surgical films
• Tattoo repair films
• Transdermal smoking cessation patches
• Alcohol cessation patches

The quality improvements brought by the implementation of this system, ranging from cleanroom environmental control and raw material lamination processing to pre-delivery inspection of every batch of finished goods, can be directly witnessed by clients during factory audits and sample testing.

We have repeatedly received feedback from overseas clients that patches tend to lift and fall off easily when sweating. To resolve such end-user pain points, we carried out comprehensive upgrades to our Class 100,000 cleanroom. Below is the comparison of all quality control indicators before and after rectification:

Taking this ISO annual audit as an opportunity, we further refined and optimized the lamination manufacturing process of medical pressure-sensitive adhesives. All finished products off the production line have fully passed the complete test procedures in accordance with EN 13726-1:2023, the European standard for adhesive performance of wound dressings.

All detailed cleanroom control rules are filed into ISO system documents and implemented rigorously on a daily basis. The whole plant undergoes full-range ozone disinfection three times a day; all staff entering the production workshop must complete full secondary gowning and hand sanitization procedures.

The entire workflow, including raw material warehousing, semi-finished product transfer, and ethylene oxide sterilization of finished goods, is fully traceable. Each batch of products is retained for sampling with complete test records archived. When overseas clients conduct on-site factory audits, original documents of any batch can be retrieved and verified at any time.

This quality management system complies with mainstream global medical device regulations. The proportion of compliance across different markets is shown in the chart below:

In terms of regulatory compatibility, our system achieves a 90% alignment rate with the EU MDR medical device regulation, fully meeting the access thresholds for private local brands and clinic OEM manufacturing in the EU. For the US market, we have completed FDA registration, with an 85% matching rate against relevant quality system clauses.

Many manufacturers hold a misconception that obtaining ISO certification and passing a single audit means permanent qualification.

However, ISO 13485 is more like a year-round quality control code of conduct. Every link across the entire industrial chain, from raw material procurement, production processing, sterilization and warehousing to after-sales communication, must be strictly implemented without interruption.

For incoming inspections of raw materials such as PU film rolls, hydrocolloid rolls and medical silicone, as well as the packaging and delivery of finished products including microneedle acne patches, scar rolls, tattoo films and transdermal smoking cessation patches, standardized operation documents and corresponding test data are retained for every single process. This ensures consistent product quality without fluctuations across mass production batches.

We provide long-term OEM and ODM private-label manufacturing services for all types of medical adhesive dressings, alongside bulk supply of hydrocolloid raw material rolls. Supported by our mature ISO 13485 standardized production lines, we deliver one-stop solutions for global purchasers, covering compliant custom development, private-label production and full-container mass supply.

Distributors, medical beauty brands and cross-border purchasers from all over the world may directly contact our business team if you need samples, quotations or on-site factory audits. We offer online virtual factory tours and welcome offline site visits. We will provide customized quotations and a full set of compliance qualification documents based on your specific product demands.