Another Milestone in Contract Manufacturing: Our Single-Use Endoscope Sheath Is Expected to Obtain Taiwan Medical Device Registration

Qingdao, September 2026 — After more than one year of close collaboration, the Single-Use Endoscope Sheath manufactured under contract by Qingdao Precision Medical Technology Co., Ltd. is expected to obtain its medical device registration certificate in Taiwan this month.

Following registration, the product is expected to proceed to formal commercial orders, completing the full journey from contract development to compliant market entry.

One Year of Collaboration: From Development to Registration

As a sterile medical consumable, the Single-Use Endoscope Sheath requires strict control over the manufacturing environment, production processes, and supporting registration documentation.

Over the past year, our team has worked closely with the registration holder throughout key stages, including:

• Product structure and design confirmation

• Manufacturing process development and validation

• Pilot production in a controlled cleanroom environment

• Sterilization validation

• Preparation and submission of technical documentation

Through close coordination at every stage, we supported the product in entering the registration review process with a complete and compliant technical package.

For the customer, the registration certificate represents an important step toward legally marketing the product in Taiwan.

For us, it represents another validation of our contract manufacturing capabilities in supporting overseas medical device registration.

Supporting the Medical Device Registration Holder System

Under the medical device registration holder system, the registration holder takes responsibility for the product throughout its lifecycle, while the contract manufacturer focuses on manufacturing and quality-system support.

Effective collaboration between both parties can be critical to registration efficiency and time to market.

Through our long-term contract manufacturing experience, we have developed a structured cooperation model covering:

◆ Registration Documentation Support

Timely preparation of process documents, validation reports, inspection records and other technical documentation required for registration and quality-system review.

◆ Rapid Response & Coordination

Dedicated support for sample preparation, supplementary documentation and on-site inspections, helping each stage move toward timely closure.

◆ Quality-System Collaboration

Effective alignment between the contract manufacturer's quality system and the registration holder's system, with clearly defined responsibilities and complete traceability.

From Endoscope Distal Attachments to Argon Beam Electrodes

The registration of the Single-Use Endoscope Sheath in Taiwan is not an isolated achievement.

Previously, we supported partners as a contract manufacturer in obtaining registration certificates for:

• Endoscope Distal Attachment Cap — Class II medical device

• Single-Use Argon Beam Electrode — active Class III medical device

These projects have allowed us to accumulate experience across different product classifications and registration pathways, from domestic registration to overseas registration.

Behind each successful registration is a reusable manufacturing and compliance capability:

Design Optimization → Manufacturing Process Development → Cleanroom Production → EO Sterilization Validation → Sterility Testing → Technical Documentation

One-Stop ODM/OEM Support for Overseas Medical Device Brands

For medical device companies planning to enter Taiwan or other overseas markets, we provide integrated support from concept development to compliant mass production, including:

• Structural optimization and Design for Manufacturability (DFM) assessment

• Dedicated tooling and fixture development

• Class 100,000 cleanroom production

• Ethylene Oxide (EO) sterilization validation

• In-house sterility and residual testing

• Technical documentation support for registration submissions

Regardless of the customer's registration pathway, we can integrate quickly into the project as a contract manufacturing partner and provide close technical and quality-system cooperation.

From Design to Compliant Market Entry

Behind every registration certificate is more than a document — it represents more than a year of systematic collaboration between the registration holder and the contract manufacturer.

If you are looking for an ODM/OEM partner with experience in the medical device registration holder system, multi-category contract registration projects, and overseas registration support, we welcome the opportunity to work with you.

From design and optimization to compliant market entry — let's complete the final mile together.

Qingdao Precision Medical Technology Co., Ltd.

Precision Manufacturing · Medical Innovation · OEM/ODM