Certifications

1. Product medical industry certificate
The medical industry requires CE, ISO, FDA, GMP, WHO, PNDT, BIS, NABL, and AERB certificates. You can filter the certificate yourself if necessary.

1）CE certification
CE certification means that only the product does not endanger the basic safety requirements of human, animal, and goods safety rather than the general quality requirements. The coordination directive only specifies the main requirements, and the general instruction requirements are standard tasks. Therefore, the exact meaning is that the CE mark is a safety pass mark and not a quality pass mark. It is the “main requirement” that constitutes the core of the European Directive.

2）ISO Certificate 
The full name of ISO is International Organization for Standardization, translated into English is the “International Organization for Standardization.

3）FDA Certificate
The FDA is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, FDA’s role is to ensure the safety of food, cosmetics, pharmaceuticals, biologics, medical devices, and radioactive products produced or imported in the United States. It was one of the first federal agencies to protect consumers as its primary function.

4）PNDT Certificate

PNDT stands for Pre-Natal Diagnostic Techniques, and a PNDT certificate is a registration for a clinical establishment that uses ultrasonography (USG). The PNDT Act was enacted in 1994 to prevent sex selection and female foeticides and was amended in 2003 to become the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act (PCPNDT Act). 

5）GMP Certificate
GMP is the abbreviation of English GOOD MANUFACTURING PRACTICE, meaning “good manufacturing practice”. The World Health Organization defines GMP as a regulation that governs the production and quality management of food, medicine, and medical products.

6）WHO Certificate
World Health Organization Certification. The WHO also provides guidance and standards for the quality, safety, and efficacy of health products. These include the WHO’s Good Manufacturing Practices (GMP) guidelines, which are a quality management system that ensures that products are consistently produced and controlled.

7）BIS Certificate
BIS stands for Bureau of Indian Standards, which is India’s national certification body. The BIS issues certificates to ensure that products sold in India are safe, reliable, and meet quality standards.BIS certification is required for products to be sold in India, and manufacturers must obtain a BIS registration certificate if their products fall under mandatory certification categories.

8）NABL Certificate
NABL stands for National Accreditation Board for Testing and Calibration Laboratories. It is an autonomous body in India that accredits testing and calibration laboratories to ensure they meet international standards. NABL’s accreditation system is based on ISO/IEC 17011. 

9）AERB Certificate
AERB stands for Atomic Energy Regulatory Board. The AERB issues certificates and licenses for facilities and activities that use nuclear energy and ionizing radiation. The AERB’s mission is to ensure that these activities do not pose a risk to the health of the environment and people. The AERB has Regional Regulatory Centers (RRCs) in Chennai, Kolkata, and Delhi. The AERB also has a Safety Research Institute in Kalpakkam to promote and carry out safety-related research.