MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION 20. Application for manu ...

4.2 Documentation requirements 4.2.1 General: The quality management system documenta ...

Permission to import or manufacture new in vitro diagnostic medical device (1) An ap ...

The application in Form MD-7 or Form MD-8 referred to in subrule (1) relating to Cla ...

What are the requirements for import of Class-A/B/C/D In Vitro Diagnostic Medical de ...

IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE 63. Permis ...

3. Procedure for audit: The notified body shall carry out the audit in the following ...

(2) Our Authorised agent shall, — (a) act as the official representative for obtainin ...