When Chinese lubricating jelly brands aim to go global and expand into vast international markets, they first face complex and stringent regulatory certification barriers from various countries and regions. US FDA, EU CE, ISO 13485... these certifications, which sound daunting, not only have cumbersome application processes and high technical requirements but also lengthy cycles and considerable costs.
Many brands are thus deterred or take many detours on compliance issues, missing valuable market opportunities. "Export compliance too troublesome" is a common sentiment among many export-oriented brands. Pingchuang Medical, with its comprehensive global certification system, provides these brands with a fast and convenient "customs clearance" shortcut.
How does Pingchuang Medical's global certification system simplify the process?
1.Complete Qualifications, Covering Mainstream Markets:
Pingchuang Medical has long prepared and invested heavily to successfully obtain core authoritative certifications required for entry into major global markets, including:
US FDA 510(k) filing: A key pass for medical devices (including some personal lubricants) to enter the US market.
EU CE certification: Complies with relevant EU directives (e.g., MDR medical device regulations), a mark for free circulation of products in the European Economic Area.
ISO 13485 Medical Device Quality Management System Certification: An internationally recognized quality management standard for the medical device industry, a basic requirement for medical device manufacturers in most countries worldwide.
Domestic Class II Medical Device Registration Certificate: Ensures product compliance in the domestic market.
2.Free Authorization, Sharing Certification Achievements:
For cooperative brands, Pingchuang Medical generously offers free authorization to use its acquired global certification qualifications. This means brand owners do not need to start from scratch to apply for these complex and expensive certifications; they can directly "borrow" Pingchuang Medical's qualification endorsement, allowing their products to legitimately meet target market regulatory requirements when exporting.
3.Significantly Shorten Market Launch Cycle, Seizing First-Mover Advantage:
Independently applying for these international certifications typically takes 12-24 months or even longer. By sharing Pingchuang Medical's qualifications, products can achieve "instant" compliance after formula and packaging confirmation, greatly shortening the time to enter international markets and enabling brands to quickly seize overseas market opportunities.
4.Noticeably Reduce Certification Costs, Traveling Light:
A single international certification can cost hundreds of thousands. Pingchuang Medical's free authorization directly saves brands this huge expense, allowing them to invest more funds in product localization, market promotion, and channel construction. On average, it can save about 200,000 RMB in certification-related costs per project.
5.Professional Regulatory Support, Averting Risks:
Pingchuang Medical has rich export experience and a professional regulatory team, capable of providing cooperative brands with target market regulatory consultation, label review, technical document preparation support, etc., helping brands avoid risks that may arise from unfamiliarity with regulations.
If you are troubled by export compliance issues for your lubricating jelly products, Pingchuang Medical's global certification system will be your most effective "customs clearance" assistant. Pingchuang Medical, with its mature qualifications and professional services, helps your brand easily overcome international market entry barriers, quickly achieve global layout, and make "exporting no longer troublesome."
