Little Doctor International (S) Pte. Ltd. supplies goods for treatment, diagnostics and prevention of illness and that is why we responsibly approach the issues of registration and certification according to the declarations of legal rights in each of these countries, where our goods are sold.
The production is certified and passes a periodic audit for compliance with ISO 13485:2003 international standard “Medical products. Quality Management System”. This standard specifies requirements to quality management systems that are responsible for designing, developing, producing and servicing medical products.
CE-mark certification of medical devices – this is a requirement, without which it is currently impossible to sell medical products in Europe and many other countries all around the world. All goods supplied by us have the right to be labeled with the CE mark, as the production meets safety requirements established by the European Union Directive 93/42/EEC about medical products.
Company TUV SUD Product Service GmbH. Germany provides certification to international standards and European Union standards, as well as periodic audits of production.
In most CIS countries, a procedure for registration of medical products is established in the state registers of medical devices which are maintained by the Ministries of Health (Health care). Sometimes special registration is required for measuring instruments, and these include products for measuring blood pressure and pulse. And for these the metrological certificate (certificate of type approval of measuring instrument) are obtained by authorities in the state metrology centres.
Medical products supplied by Little Doctor International (S) Pte. Ltd. brand pass completely all phases of state control, registration and certification established by the legislation of each of the CIS countries.
All parts of the state registration and certification in your country can be obtained from official distributors and partners of the Company.