Alpine Quality Consultants provide Guidance & Support by Highly Qualified, Experienced and Professional (Advisors & Experts) for Export Product Registration and Import Licence in India:
IMPORT LICENCE & REGISTRATIONS
As per D & C Act 1940
- Registration Certificate (Form 41)
- Import Licence on (Form 10)
LICENCE AND PERMISSION AS PER MEDICAL DEVICE RULE 2017 EFFECTIVE FORM 01ST JANUARY 2018
- Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training on Form MD-13
- Licence to Import Medical Device on Form MD-15
- Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training on Form MD-17
- Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients on Form MD-19
- Permission to import of small quantity of medical devices for personal use on Form MD-21
EXPORT PRODUCT REGISTRATIONS
USA
- FDA Establishment Registration
- FDA Device Listing for Class I (510(k) Exempt Devices)
- FDA 510(k) for Medical Devices
- CFG USFDA
EUROPE
- EU FSC
- Product Registrations in EU Countries.
Great Britain (United Kingdom), Ireland, China, Canada.
AFRICAN COUNTRIES: Ghana, Nigeria, Benin, Burkina Faso, Central African Republic, Congo, Egypt, Ethiopia, Gabon, Liberia, Malawi, Morocco, Rwanda, Sierra Leone, Sudan, Tanzania, Togo, Cameroon, Uganda, Kenya, South Africa.
GULF / MIDDLE EAST COUNTRIES: Bahrain, Kuwait, Saudi Arabia, Syria, Qatar, Dubai, Oman.
ASIAN COUNTRIES: Bangladesh, Malaysia, Indonesia, Nepal, Sri Lanka, Philippines, Singapore, Thailand, Vietnam, Korea.
RUSSIA / CIS: Russia, Ukraine, Uzbekistan, Belarus, Azerbaijan, Turkmenistan
