Standards & Certifications Applicable to Medical Device & Pharma Sector

 

    1: EXCIPACT Certification

    2: EFfCI Certfication

    3: ISO 13485:2015 Quality Management Systems for Medical Devices

    4: GMP Pharma for Good Manufacturing Practices

    5: GDP - Good Distribution Practices

    6: ISO 135378:2017 - Packaging for Medical Devices

    7: CE - Medical Devices including 

    8: Invitro Diagnostic Medical device Regulation (EU) 2017/746 (IVDR)

List of Notified Body registered with CDSCO under MDR,2017 (Dated 23 Feb, 2022)

 

                As per Notice bearing File no. 29/Misc/3/2017-DC (288) by CDSCO dated 23rd Feb, 2022, in extention to MDR, 2017, an updated list has been published about notified bodies who can conduct audit at manufacturing site under provisions of MDR, 2017.

 The list is as follow.

1. Intertek India Pvt. Ltd.

2. M/s TUV Reinland Pvt. Ltd.

3: M/s TUV SUD South Asia Pvt. Ltd.

4: M/s Dnv GI Business Assurance India Private Limited

5: M/s BSCIC Certifications Pvt. Ltd.

6: M/s MTIC INTERCERT India Private Limited

7: M/s Zenith Quality Assesors Pvt. Ltd.

8: M/s International Certification Services Pvt Ltd.

9: M/s TUV India Pvt. Ltd.

10: M/s IRCLASS Systems and Solutions Private Limited