Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare

Transcription

1 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-I To, /" ~/s B.L. Lifesciences Pvt. Ltd., A-245, Okhala Industrial Area, Phase-I, New Delhi- 20 SUB: -Registration of MIs Foshan Nanhai Baihe,Medical Technology Co., Ltd, having a factory premises at Technology Garden, Taoyuan West Road, Shishan Nanhai Foshan Guangdong Procvince P.R. China P.c under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application No. BLL/ dated received by this office vide dairy no dated and replies received by this office vide diary nos dated , dated and dated 23/09/2011 on the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is issued herewith for the manufacturing site a10ngwith the name(s) of medical device(s) imported under the said Certificate subject to the following conditions. (', "'.JI 1. The medical device(s) shall conform to t~e,s~dards I specifications mentioned in the Second Schedule of the Drugs a~co;~~etics Act! ISO I MDD I or such other standards or specifications app~~ l5y this Directorate. 2. Dispute, if any, in respect ~~e payment of fees and submission of TR6 challan, shall be settled between.the bank and the applicant. 3, The medical device will be required to bewithdra\\ti from sale from the market in caseanyl.llldesirablereactlons due tofaihirec)(ihe.device or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports on the medical device, if any. 4. This registration in no way relieves you of the responsibility of complying with other provisions of the Drugs & Cosmetics Act and Rules thereunder, and any oilier provisions of any other Acfaiid Rulesa.ppTiCableirifhe matter concerned.

2 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency 'of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. YOlt:ailhfUlIY, M--~~~-, (Dr. Snrinder Singh) Drugs Controller General (India)

3 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv 01 Health & Eamilv Wellare FDA BHAWAN, KOllA ROAD, NEVI DELHI-ll0 002 [INDlAJ Form4J... (See rule 27-A) Registration Certificate issued for import of devices into India Under Drugs and Cosmetics Rules, Mis Foshan Nanhai Baihe Medical Technology Co., Ltd, having a Factory Premises at Technology Garden, Taoyuan West Road, Shishan Nanhai Foshan Guangdong Procvince P.R China P.c has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate. 2. Name(s) of devices(s), which may be imported under this Registration Certificate: Please refer to the enclosed list o~~ 3. This Registration Certificate Shal1!.\~C~fro.m to unless it is sooner (' X ~ suspended or cancelled under~e rules. 4. This Registration Certificate is issued through the office of the manufacturer or his authorised agent in India Mis B.L. Lifesciences Pvt. Ltd., A-245, Okhala Industrial Area, Phase-I, New Delhi- 20. who will be responsible for the business activities ofthe manufacturer in India, in all respects. 5. This Registration Certificate is subject to the conditions stat~d overleafandto such other conditions as may... be~pecifiedintheac:t an(itherules,.froll1_~tt\~wjv~lll~.. ~"s reo ~Q~.:J ~~ f ~ w 0 U Z ~~~ LICENSING AUTHORITY Seal/SUlmp :'.5'1. "r~ ~ :>.,c,-;,,~;f~r SINGH ;'i16ii; '>11;lii:Drugs Controller (India) 'l<lh-lt7.l <leit "Slf.l~ '''(ifq Ole. Ger"o:ai of Health Services FDA Bhawan, Kotla Road, New Delhi

4 1. The Registration Certificate shall be displayed at a prominent place by the authorised agent. 2. The manufacturer or his authorised agent in India shall comply with the conditions of ~ theimport licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any device pertaining to this Registration Certificate declared by the Regulatory Authority. of the country of origin or by any Regulatory Authority of any other country, where the device is marketed/sold or distributed. In such cases, action equivalent to that taken with reference to the concerned device in the country of origin or in the country of marketing shall be followed in India also, in consultation with and as per the directions of the licensing authority. The licensing authority may, however, direct any further modification to this course of action, including the withdrawal of the device from Indian market. 4. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in testing, or in documentation, as the case may be, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separate application along with the registration fee, as specified in clause (ii) of sub rule (3) of rule 24-A. 5. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and /01' address of the registered office! factory premises operating under this Registration Certificate. Where any such change in the constitution of the finnand/or address takes place, the current Registration Certificate shall be deel:ned to be valid for a maximum period ofthree months from the date on which the change has taken place.. ~un]ess,~inthemeantime,.a f. hr~gi?tr9-tioncertificatehas been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises.

5 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv of Health & Familv Welfare FDABHAWAN, KOllA ROAD.NEW DELHI l1NDW NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER.. REGISTRATION CERTIFICATE NO. MD DATED VALID UPTO ce'l:t..ilven~~~~~~rinon(~rile} (All'Sizes: Singt.~~~~~i;.?;tiubleLum~n, Triple Lumen, Q~ildruple Lum.~~if- ;:.:;:.i:; :. ;. 2. Hemadialysis\Callletet,:(Nan Sleri lel (All~izte't:.~i'lg~~~~~:irt~~~i~l~(L~"i'en,Triple Lumen). r:,. "lfem$:z(.... " ty (,\~("C o(>~~ ;( ::;{;'JJ2::[:::!:"c:.~{ LICEN~~~~ s~~s ~. Dt. SURINDER SINGH ~ ~ ('lffii)/oruqs Controller (India) ~ ~ +1t'I~,hmq<l Ole. General of Health services FDA Bhawan, Kotla Road, New Deihi

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