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Why Partner With Meilan

Why Partner With Meilan Company Production Quality Technology

ABOUT MEILAN

Founded in 2009, located in the hometown of Mei Lanfang - Taizhou, Jiangsu Province. Jiangsu Meilan Medical Devices Co., Ltd. is one of the earliest Chinese self-heating patch manufacturers and high-tech enterprise that was engaged in research, development, production and sales of heat packs. The company has focused on OEM production for 14 years and has served many important brands and companies around the world.

Meilan has succeeded in cultivating various researchers and developing more than 130 types of heat pads. In particular, the medium and low temperature skin patches, special-shaped function patches,heavy heat packs, that Meilan has independently developed are among the best in China. The annual output of heat packs reaches 200 million pieces, and the daily output can reach more than 600,000 pieces. Products are exported to more than 30 countries and regions, such as Britain, Germany, France, Spain, Singapore, South Korea, the United States. Meilan regards product quality as its lifeline since its establishment and has established a strict production quality management system in every link of production and a complete product quality traceability system. Meilan has always won the reputation of integrity, guaranteed benefits with quality, led the market with new technology, created the market, and served the market.

WHY PARTNER WITH MEILAN

Meilan regards product quality as its lifeline since its establishment and has established a strict production quality management system in every link of production and a complete product quality traceability system.

COMPANY

MEILAN has earned several honors and certifications over the years, which reflect our commitment to quality, safety and responsibility.
Meilan has BSCI, ISO13485, CE,MHRA,domestic second-class medical device production license and registered FDAThese recognise our quality management system and our ability to consistently deliver products and services that meet customer and regulatory requirements.

National High-Tech Enterprise: This honor is granted to companies that demonstrate innovative capabilities, strong research and development activities, and a commitment to technology advancement.

Patent certificates: We have obtained various patent certificates for our unique product design and technological innovation. There are nearly 167 registered trademarks and 97 national patents, including 5 invention patents and 17 utility model patents.

Development prospects of the company:
Our plans for the future include setting clear goals and strategies, keeping up with industry changes and market demands, and utilising innovative technologies to improve product quality and production efficiency. We aim to become the leader in the disposable self-heating heat pack industry and provide the best products and services to our customers.

Our standardized factory campus features complete production facilities and a systematic management system. We maintain strict quality control and standardized operation for stable mass production.

Building

Boasting 26 advanced production lines, we realize standardized mass production and strict quality control in every process.

Work shop

Office

Complete QC system covers raw material inspection, in-process sampling and final product testing. All items comply with international standards to deliver reliable products.

Laboratory

Showroom

Warehouse

HEAT THERAPY PATCH PRODUCTION PRECESS

aw material incoming inspection, core ingredients scientific mixing, quantitative material filling, automatic product molding, strict finished product quality testing, standardized outer packaging, and moisture-proof finished goods warehousing and storage.

Cleanroom heating pad production workshop

This is our standardized heat patch production workshop, designed with a clean and modern environment.
Multiple production lines are running in an orderly manner. Workers are engaged in product sealing, inspection and packaging at their workstations, completing standardized production processes with professional equipment.
With clear station numbers and unified production workflows, the workshop ensures high efficiency and stable quality. As part of our 26 production lines, it supports large-scale and standardized order fulfillment.
Managed in strict accordance with medical device production standards, the clean environment and standardized operations guarantee every heat patch meets international quality requirements.
Thermal pad filled with iron powder

Filling volume determined by heat patch's required duration & temperature.
Filling Accuracy & Mold Compatibility:

1. Filling Volume Consistency: The weight deviation of materials per mold cavity shall be ≤ ±2% (corresponding to each groove in the mold in the figure), to avoid variations in heating duration and temperature.

2. Mold Cleanliness: The mold surface shall be free of residual materials and oil stains, preventing contamination of new materials or groove blockage that may affect product shape precision.
Heat patch assembly line workshop

1. The first flattening machine flattens heat patch to ensure even material distribution.
2. The conveyor belt conveys heat patch to realize adsorption, with quality inspectors carrying out random sampling simultaneously.

3. The second flattening machine, further ensures uniform heating area.

QUALITY

Each heat patch production line shall be staffed with 2 quality control inspectors, responsible for the following inspections:

1. First-off Mold Product Verification

2. Size & weight shall comply with Production Notification requirements

3. Dimension deviation ≤ ±2mm For products with diameter ≤ 2mm

4. Material inclusions ≤ 3 pieces

Check if there are any defects in the heating pad.
Check the weight of the heating pad products

HEAT PATCH CERTIFICATION

CE CE marking (short for Conformité Européenne) is a mandatory EU safety and health compliance mark for products sold in the European Economic Area (EEA: EU 27 + Iceland, Norway, Liechtenstein). For warm patches/heat therapy patches (Class I medical devices), CE certification proves compliance with the Medical Device Regulation (MDR, EU 2017/745)—the strict EU framework for medical device safety, performance, and quality control.

Long-term validity

FDA FDA stands for the U.S. Food and Drug Administration, the federal agency responsible for protecting public health by ensuring the safety, effectiveness, and quality of medical devices, foods, drugs, and cosmetics sold in the United States. For warm patches / heat therapy patches, FDA registration is the legal requirement for U.S. market access.

FDA20230316-20251231

ISO 13485 is the globally recognized quality management system standard specifically for medical devices. For heat patches and warm therapy products, ISO 13485 certification proves our factory follows strict, standardized production, risk control, and quality inspection procedures throughout the whole manufacturing process. This medical-grade quality system ensures stable product performance, safe raw materials, controlled heating temperature, and reliable hygiene standards. Different from ordinary industrial ISO standards, ISO 13485 focuses on medical product safety, traceability and customer health protection. With ISO 13485 certification, our warm patches fully meet international medical device quality requirements, support global market access, and deliver stable, safe and high-quality heat therapy products to worldwide customers.

ISO13485 20240828-20271108-

MSDS, also known as SDS (Safety Data Sheet), is an essential global safety document that details the chemical composition, hazard identification, handling, storage, transportation and emergency measures of products. For warm patches, the MSDS/SDS report fully discloses raw materials such as iron powder, activated carbon, vermiculite and salt. It verifies that our heat patches are non-toxic, non-corrosive, non-flammable and environmentally friendly. This official safety document is required for international shipping, customs clearance and cross-border sales. It guarantees safe transportation and daily use, helping customers and distributors meet import regulations in Europe, America and other global markets. Manufactured with safe raw materials, our warm patches are fully supported by complete MSDS certification, ensuring user safety and global regulatory compliance.

Long-term validity

BSCI 2025-2027

China Class II Medical Device Manufacturing License is the official approval issued by China’s provincial drug regulatory authorities, permitting the legal production of Class II moderate-risk medical devices such as warm patches and heat therapy products中国政府网. This mandatory license verifies that our factory meets strict national standards for production facilities, equipment, quality control, and staff qualification, complying with China’s Medical Device Supervision Regulations and GMP requirements中国政府网. For warm patches, it confirms stable heating performance, skin safety, non-toxic raw materials, and full-process traceability. It is a key qualification for domestic sales, global export, and cross-border e-commerce compliance. Holding this valid license demonstrates our medical-grade manufacturing capability, ensuring consistent quality and regulatory compliance for customers worldwide.）

CLASS II 2022-2027

MHRA (MHRS) Registration for Warm Patches MHRA stands for the Medicines and Healthcare products Regulatory Agency — the UK government body responsible for ensuring the safety, quality, and performance of medical devices sold in the United Kingdom. For warm patches / heat therapy patches, MHRA registration is the mandatory UK market access approval. Warm patches are classified as Class I low‑risk medical devices under UK medical device regulations. What MHRA registered means: The product and manufacturing facility are officially listed with the MHRA. Compliant with UK safety and performance standards (stable heat output, skin safety, non‑toxic materials). Manufactured under ISO 13485 / GMP‑compliant quality control. Supports legal sale and distribution in England, Scotland, and Wales. Why it matters: Proves UK regulatory compliance and builds trust with British buyers. Required for UK customs clearance and retail distribution. Demonstrates medical‑grade safety and consistent quality.

MHRA 2023-2027

TECHNOLOGY

Meilan has two production line inspectors for each production line, and another two inspectors will regularly inspect the product quality of the production line. In addition, every batch of products will be sampled and sent for temperature performance test. Each batch of heat packs undergo rigorous testing to ensure quality.
Once the heat packs have passed quality control, they are packaged for distribution. where they are carefully wrapped and labeled. Our product inspection team then scrutinizes each batch to ensure there are no defects or issues before boxing and warehousing.