For the purpose of import of Medical Devices in India , the procedure for registration and import licence as prescribed under the Drugs and Cosmetics Rules is followed.

REGISTRATION OF MEDICAL DEVICES FOR IMPORT

1.      Application for Registration Certificate in respect of the premises and the devices manufactured by the manufacturer and meant for import into India is required to be made by the manufacturer or importer or his agent in India.

2.      A fee of US$ 1500 or its equivalent shall be paid alongwith the application as registration fee for the premises where the devices, intended to be imported are being manufactured by the manufacturer.

3.      A fee of US$ 1000 or its equivalent shall be paid for registration of single Medical Device (which may include variation in sizes or shape without any change in the material or method of use) and an additional fee US$1000 for each additional device shall be paid.

4.      The fee shall be paid through a challan in the Bank of Baroda as prescribed under the said Rules.

5.      The informations and undertakings required to be furnished under Schedule DI and DII may be modified to suit the requirements of devices in place of normal pharmacological products.

On grant of RC Certificate , import license is applied by the Importer.

(A) Applicant Details

1. Applicant’s company name, address and contact number.

2. Name and address of foreign manufacturer (Manufacturing premises).

3. Copy of the Plant Master File.

4. Name and address of the local authorized representative.

5. Name and address of the importer.

6. Local manufacturer, if any processing is being done in the country.

(B) Product Information

1. Proprietary/Brand name.

2. Brief description of the device.

3. Category of device.

4. Intended use and method of use.

5. Medicals specialty in which the device is used.

6. Qualitative and quantitative particulars of the constituents.

7. Brief description of the method of the manufacture and specification of the materials used.

8. Contraindications, warnings, precautions potential adverse events and alternate therapy, wherever applicable.

9. List of accessories and other devices or equipment to be used in combination with the device. Other descriptive information, including accessories packaged with the product.

10. Variations in shape, style or size of the device, if applicable.

11. Labeling details conforming to Drugs and Cosmetics Rules, 1945.

12. Physician manual and promotional literature (Literature insert) in English.

13. Packaging description including pack sizes.

14. Recommended storage conditions.

15. Summary indications of any reported problems.

16. Details of standards to which the device conform alongwith the copy of the standard

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Introduction

Notarisation is the act of a notary public authenticating by his signature and official seal, certifying the due execution in his presence of a deed, contract or other writing, or verifying some fact or thing about which the notary public has definite knowledge. In India notarisation is performed under Notaries Act, 1952.

Need for Notarisation

Documents are notarized to certify their genuineness and prevent fraud and to make sure they are properly executed.  The Notary is considered as an impartial witness who verifies signers and ensures they have entered into agreements knowingly and willingly. In short, its objective is to determine everything is true and genuine on the document.

Some commercial documents should be attested by certain Chamber of Commerce and Industry before submitting to the Ministry of External Affairs.

Generally, documents required for Notarisation are:

1. A duly-filled Application Form for Notarization/Attestation;

2. Original and photocopy of the legal documents,

3. Signed Covering Letter with attestation purpose and the list of the commercial attestation document from the Company of the applicant;

4. Signed Covering letter with attestation purpose and the list of the attestation document from the applicant himself/herself if it is for civil use;

5. Original and photocopy of applicant’s passport and agent’s passport for civil attestation purpose.

APOSTILLE DOCUMENTS

Introduction

Apostille Certificates are issued by Ministry of External Affairs (MEA), Government of India on birth certificates, death, power attorney, marriage certificates, educational certificates and affidavits. Before getting apostilled all the concerned documents must be authenticated by regional offices located in every state.

An Apostille is granted by apostillisation office of a country which is a member of the Hague Convention, 1961. Apostille is certificate which verifies and confirms the seal and signature of person who authenticated the document. Some people call this ’superlegalisation’.

Need for Apostillization

Sometimes just a simple notarisation is not enough, one might be asked to get one’s documents apostilled, it is known as ‘superlegalisation’ or legalization of documents for overseas use. To bypass it, one has to do is just to get one’s documents apostilled. Once this is done, document is recognised worldwide, such as travel document. Those countries which are signatory to Hague Convention can only issue apostille.

Q1. When did Payment and Settlement Systems Act, 2007 (PSS Act, 2007)  came into effect?

Ans. The PSS Act, 2007 received the assent of the President on 20th December 2007 and it came into force with effect from 12th August 2008.

Q2. What is the objective of the PSS Act, 2007 ?

Ans. The PSS Act, 2007 provides for the regulation and supervision of payment systems in India and designates the Reserve Bank of India (Reserve Bank) as the authority for that purpose and all related matters. The Reserve Bank is authorized under the Act to constitute a Committee of its Central Board known as the Board for Regulation and Supervision of Payment and Settlement Systems (BPSS), to exercise its powers and perform its functions and discharge its duties under this statute.  The Act also provides the legal basis for “netting” and “settlement finality”. This is of great importance, as in India, other than the Real Time Gross Settlement (RTGS) system all other payment systems function on a net settlement basis.

Q3. What are the Reguations made under the PSS Act, 2007 and when did they come into force ?

Ans. Under the PSS Act, 2007,  two Regulations have been made by the Reserve Bank of India, namely,  the Board for Regulation and Supervision of Payment and Settlement Systems Regulation, 2008 and   the Payment and Settlement Systems Regulations, 2008. Both these Regulations came into force along with the PSS Act, 2007 on 12th August 2008.

Q4. What are the objectives of these two Regulations?

Ans. The Board for Regulation and Supervision of Payment and Settlement Systems Regulation, 2008 deals with the constitution of the Board for Regulation and Supervision of Payment and Settlement System (BPSS), a Committee of the Central Board of Directors of the Reserve Bank of India. It also deals with the composition of the BPSS, its powers and functions,  exercising of powers on behalf of BPSS, meetings of the BPSS and quorum, the constitution of Sub-Committees/Advisory Committees by BPSS, etc.,  The BPSS exercises the powers on behalf of the Reserve Bank, for regulation and supervision of the payment and settlement systems under the PSS Act, 2007.

The Payment and Settlement Systems Regulations, 2008 covers matters  like form of application for authorization for commencing/ carrying on a payment system and grant of authorization, payment instructions and determination of standards of payment systems, furnishing of returns/documents/other information, furnishing of accounts and balance sheets by system provider etc., .

Q.5 Are entities operating a payment system or intending to operate a payment system required to get a license, approval or authorization for the purpose?

Ans. In terms of Section 4 of the PSS Act, 2007  no person other than the Reserve Bank can operate or commence a payment system unless authorized by the Reserve Bank. Any person desirous of commencing or operating a payment system needs to apply for authorization under the PSS Act, 2007(Section 5).

Source:RBI