For many enterprises wishing to enter or expand in the medical lubricant market, product compliance certification is undoubtedly a major hurdle. Especially when it comes to Class II medical device registration, the "high certification standards, long application cycles, and large investment costs" often deter enterprises, causing them to miss market opportunities.
However, by partnering with professional manufacturers like Pingchuang Medical, which already possess complete qualifications, these difficulties can be easily resolved, achieving a "one-time" solution.
Pain Point One: Strict Certification Standards, High Technical Barriers, "Difficult" Independent Application.
As medical devices, the safety and effectiveness of medical lubricants must be rigorously verified. Applying for a Class II medical device registration certificate requires submitting a large amount of professional technical documentation, including product technical requirements, risk analysis materials, clinical evaluation materials (possibly involving clinical trials), instruction and label samples, and quality management system documents. This places extremely high demands on an enterprise's R&D capabilities, quality management level, and understanding of regulations.
Pingchuang Solution: Share a Full Set of Compliance Qualifications, Lowering Entry Barriers.
Pingchuang Medical has successfully obtained a Class II medical device registration certificate for medical lubricants, ISO 13485 medical device quality management system certification, as well as US FDA 510K and EU CE certifications required for export. Cooperative brands can directly share these authoritative qualifications, eliminating the need to overcome complex technical barriers and regulatory challenges themselves, achieving "zero-threshold" compliant market launch for products.
Pain Point Two: Long Application Cycles, Market Opportunities "Cannot Wait."
From material preparation, type testing, technical review to final approval, the application cycle for a Class II medical device registration certificate typically takes 12-24 months, or even longer. Such a long wait often means missing the best market launch timing in a rapidly changing market.
Pingchuang Solution: Significantly Shorten Market Launch Time, Seizing First-Mover Advantage.
By partnering with Pingchuang Medical, brand owners can save this lengthy certification waiting period. After product formulation and packaging are confirmed, relying on Pingchuang's existing qualifications, they can quickly enter production and market promotion stages, shortening the new product launch cycle by an average of 18 months or more.
Pain Point Three: Huge Certification Investment, Financial Pressure "Unbearable."
Various testing fees, clinical evaluation fees (if needed), consulting service fees, and the human and material resources invested during the certification process make the total cost of independently applying for a medical lubricant certification often reach hundreds of thousands or even millions. This is a considerable financial pressure for startups or SMEs.
Pingchuang Solution: Zero-Cost Qualification Authorization, Significantly Reducing Investment.
Pingchuang Medical offers free authorization services for medical device and international certification qualifications, directly saving cooperative brands this substantial certification fee. According to statistics, this saves an average of about 200,000 RMB in R&D, design, and certification-related expenses per project.
Choose Pingchuang Medical to customize medical lubricants, and you will no longer worry about the "difficulty, length, and high cost" of certification. Pingchuang Medical, with its mature global compliance certification system, professional R&D and production capabilities, and one-stop considerate service, will clear these three major pain points for you at once, making your brand journey smoother.
