The ISO 9001:2015, EN ISO 13485:2016, CE Certificate, WHO GMP, Drug License and FDA 510k is must for orthopedic implants manufacturing and import. So we request you to check all the certification before buying anything. There are also some fraud orthopaedic implants manufacturing companies in India who are showing online that they are big Manufacturers but if you visit their register office so you will know that they are doing fraud business. So please be careful while selecting anyone.