GOVERNMENT OF PAKISTAN
MODEL CUSTOMS COLLECTORATE OF APPRAISEMENT
CUSTOM HOUSE, KARACHI.
No. CC-35/2012(A) Dated: 30.11.2012
PUBLIC NOTICE NO. 6/2012 (A)
SUB: CLASSIFICATION OF SURIGICAL MESH.
This representation is made by M/s. Masood Aziz & Associates, Karachi on behalf of M/s. Ali Gohar & Company (Pvt.) Ltd., for issuance of advance ruling for classification of surgical mesh under the Pakistan Customs Tariff in terms of Para 2 of Customs General Order No. 12/2002 on following grounds: -
“Our client M/s. Ali Gohar and Company (Pvt.) Limited intend to import Surgical Mesh which is implanted in the body through a surgical procedure (hemioplasty) for treating hernia. Surgical Mesh is classified as a Class 11 Medical Device by FDA in USA and is regulated by Medical Device Directive 93/42 EEC in European Union. In order to have a smooth clearance at the time of import under correct PCT Classification, we request you to kindly issue an advance ruling in terms of the provisions of FBR’s Customs General Order 12/2002 Paragraph No. 2.
2. Surgical Mesh is a sterile material made from various polymers. The most commonly used materials are polypropylene, polyester and ePTFE. It is pliable, non allergic, insert, non-carcinogenic capable of stimulating fibroblastic activity for incorporation in the tissues. Surgical Mesh can be non-absorbable, composite (combination of absorbable and non-absorbable fibers) or with an absorbable and nonabsorbable barrier.
3. Hemia is a protnion of an internal organ or part due to a defect in abdominal wall. It can occur anywhere in the abdomen Hernia are classified according to anatomical location for example Inguinal Hernia, Ventral hernia, Femoral Hernia etc.
4. Literatures published by some of the leading manufacturers of Surgical Mesh are enclosed as Annex-B highlight the description / specification and use of the surgical mashes for the treatment of hernia. It would be useful to reproduce below the definition of Medical Device as defined by the FDA. (Annex-C)
“A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:
· Recognized in the official National Formulary, or the United States pharmapoeia, or any supplement to them.
· Intended for use in the diagnosis of disease or other conditions, or in the cure mitigation treatment, or prevention of disease in man or other animals, or
· Intended to effect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not depended upon being metabolized for the achievement of any of its primary intended purposes.”
In accordance with the above stated definition, DFA regulates and grant permission to Market-Surgical Mesh under 510 (k) Medical Device Submission Requirements, and as issued specific guide lines for this purposes Annex-D. FDA give specific approval with a distinct 510(K) serial number to each manufacturer of surgical mesh indicating its intended use alongwith the product specifications prior to the marketing. It is an official permission to sell the goods in question as a medical device under the relevant regulatory clauses. (Specimen Permission letter of FDA is enclosed at Annex-E).
In order to facilitate the issuance of an appropriate Advance Ruling by the Customs, we would like to indicate four PCT headings along with our comments. The first three headings do not merit consideration due o the reasons explained in detail herein below in the following paragraphs: -
i. 30.05 ii. 39.26
iii. 9018.9090 iv. 9021.9000
It would be useful to reproduce the above mentioned headings for a quick reference:
30.05 Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packing’s for retail sale for medical, surgical, dental or veterinary purposes.
- Adhesive dressings other articles having an adhesive layer:
3005.1010 --- Surgical tape in jumbo rolls
3005.1090 --- Other
- Other;
3005.9010 --- Acrynol pad
3005.9090 --- Other
In our opinion PCT heading 30.05 is not the correct heading for the classification of Surgical Mesh because its function and intended usage is completely distinct from Wadding. Gauza or Bandages which are classified under heading 3005. Such product are meant for facilitating the healing process of the outer layer of the skin after some kind of incision/surgery or for wound management. The surgical Meshes in question do not perform any such function and, therefore, this heading should be ruled out. As is evident from the literature referred to above, the surgical mesh has a very specific use. Treatment of hemia).
39.26 Other articles of plastics and articles of their materials of heading of 39.14
3926.1000 -- Article of apparel and clothing accessories (including gloves, mittens and mitts):
3926.2010 --- Plastic belts
3926.2090 --- Other
3926.3000 - Fittings for furniture, coachwork of the like
- Statutes and other omamental articles:
3926.4010 --- Omamental articles of plastics
3926.4020 --- Plastic bangles
3926.4030 --- Spangles of plastics
3926.4040 --- Plastic beads
3926.4090 --- Other
- Other
3926.9010 --- Synthetic floats for fishing nets
3926.9020 --- Coils of plastics (contraceptives and accessories therefore)
3926.9030 --- Transmission, conveyor or elevator belts
3926.9040 --- Laboratory ware
3926.9050 --- Colostomy bags and urine bags
3926.9060 --- Shoe lasts
3926.9070 --- Design patterns, cards for textile and leather garments
--- Other
3926.9091 --- Plastic tags and staples for garments
3926.9099 --- Other
Heading 39.26 covers articles of Plastics and articles of their materials of heading 39.01 to 39.14, which are not covered specifically by the preceding headings of Chapter-39. Surgical Meshes manufactured from Poly Propylene, Polyester etc., may seem to all under heading 3926.9099 as an article of plastic. However, this heading would be ruled out by virtue of Chapter Note 1 (u) which excludes the article of Chapter 90 from the purview of Chapter 39. Surgical Mesh is not a general purpose plastic product. Being a sterile medical device having a specific use more clearly described in Chapter 90, it cannot be considered for classification under Chapter-39. Attention is also drawn to the provision of Explanatory Notes to heading 90.18 (Annexure-F)which states as follows:
“ This headings covers a very wide range of instruments and appliances which in the vast majority of cases, are used only in professional practice (e.g. by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc. Instruments and appliances for anatomical or autoptic work, dissection, etc., are also included, as are, under certain conditions, instruments and appliances for dental, as are, under certain conditions, instruments and appliances for dental laboratories (see Part (II) below). The instruments of the heading may be made of any material (including precious metals).”
90.18 Instruments and appliances used in medical,
Surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing Instruments.
Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters):
9018.1100 --- Electro-cardiographs
9018.1200 -- Ultrasonic scanning apparatus
9018.1300 -- Magnetic resonance imaging apparatus
9018.1400 -- Scintigraphic apparatus
9018.1900 -- Other
9018.2000 -- Ultra violet or intra-red ray apparatus
- Syringes, needles, catheters, cannulae and the like:
- Syringes, with or without needles:
9018.3110 --- With needles
9018.3120 — Without needles
9018.3200 -- Tubular metal needless and needless for sutures
- Other
9018.3910 — Dextrose and saline infusion
giving sets imported alongwith empty of non toxic bags for infusion solution
9018.3920 — Dextrose and saline infusion giving sets
--- Catheter:
9018.3931 --- Suction
9018.3932 --- Pulmonary artery
9018.3933 --- Poly’s
9018.3939 --- Other
9018.3940 --- Cannula
9018.3950 --- Surgical needles
9018.3960 --- Endo tracheal tube
9018.3970 --- Balloons
9018.3990 --- Other
- Other instruments and appliances, used in dental sciences:
9018.4000 -- Dental drill engines, whether or not combined on a single base with other dental equipment
9018.4900 -- Other
9018.5000 - Other ophthalmic instruments and appliances
- Other instruments and appliances:
9018.9010 --- Anesthesia apparatus
9018.9020 --- Stethoscopes
9018.9030 --- Surgical scissors
9018.9040 --- Surgical knives
9018.9050 --- Sphygmomano-meter
9018.9060 --- Infant incubators
9018.9070 --- Fibro dializers
9018.9090 --- Other
Instruments and appliances used in Medical / Surgical, Dental or Veterinary Sciences fall in the heading 90.18. A careful perusal of the subheadings of PCT heading 9018 as well as the scrutiny of the Explanatory Notes published by the World Customs Organization (WCO) clearly shows that Surgical Mesh do not fall in the category of products as are classified under heading 9018. Since Surgical Mesh is implanted in the body to overcome a defect, it would not fall under 9018, but will fall under 9021.
90.21 Orthopedic appliances, Including crutches, surgical
belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability.
9021.1000 - Orthopedic or fracture appliances
- Artificial teeth and dental fittings
9021.2100 -- Artificial teeth
9021.2900 -- Other
- Other artificial part of the body
9021.3100 -- Artificial joints
9021.3900 - Other
9021.4000 - Hearing aids, excluding parts and accessories
9021.5000 - Pacemakors for stimulating heart muscles, excluding
parts and accessories
9021.9000 - Other
Surgical Mesh being a Medical Device [FDA and EU guidelines] and serves as an appliance, which is implanted in the body to compensate for a defect (hernia is a defect in the muscle or surrounding tissue wall), the PCT heading 9021.9000 is the correct heading for its Classification.
The terms of heading 90.21 as reproduced above clearly answer to the description of the product in question and therefore by applying Rule 1 of General Rules for interpretation of Harmonized Coding System (which states that for legal purposes classification shall be determined according to the terms of the headings and relative Section of Chapter Notes), the product in question would fall for classification under heading 9021.9000.
“8. It is requested that a meeting of the PCT Committee set up in terms of FBR’s CGO referred to above may be summoned at an early date to determine the classification of the product referred to above and an opportunity of hearing may also be provided to our client to further elaborate the products in question intended to be imported in the near future.”
i) In order to appreciate the issue a meeting of the Classification Committee held on 16.08.2012 and 30.08.2012.The following officers/officials were co-opted as members of the Classification Committee.
1. The Principal Appraiser Group-ll, Member PCT Committee
MCC Appraisement, Karachi
2. The Principal Appraiser Group-VII Member PCT Committee
MCC Appraisement, Karachi
3. Mr. Masood-UI-Hassan Member PCT Committee
Principal Appraiser,
MCC PaCCS, Karachi
4. Mr. Abdul Qayyum, Member PCT Committee
Principal Appraiser
MCC PaCCS, Karachi
MCC Appraisement, Karachi
3. Preliminary scrutiny of the case reveals that following are the PCTs to be considered for classification of the subject goods.
a) 9018
b) 9020
c) 3005
4. The Principal Appraiser of the concerned Groups were requested to offer comments and accordingly the Principal Appraiser-ll contended as under:-
“9018. Covers instrument and appliances. The goods do not cover surgical
mesh.
9020. (i) Covers breathing appliances / orthopedic appliances. It is not of that nature.
(ii) Covers artificial parts of body such as dentures (teeth), artificial of body, pacemakers etc.
These are all artificial parts but the gauze under discussion is a sterile surgical mesh to be used as abdominal support and placed inside the abdomen to avoid abdomen stretching after Hernia operation. It is neither a body part nor an artificial part but sterile inner abdominal support.
Heading 9021 covers outer body supports such as crunches etc., and no abdominal support.
3005. The product details match with the details given in the Explanatory Note of heading 3005.
Group is of the opinion that PCT 3005 would be most suitable for the goods under reference i.e. surgical mesh."
5. The matter was discussed in detail. The learned representative of the importer produced sufficient material in support of their contention. As per the literature provided by the importer it is observed that subject goods are non absorbable inert sterile pc mesh knitted from multifilament yarn of polypropylene polymer. The mesh is intended assist in the repair and for reinforcement of hernia and other facial defects required support of a non absorbable mesh. The muscle and tendon send out fibrous which grows around and through the mesh, incorporating the mesh permanently tissue. Therefore, the Committee is of the view that these sort of goods may be as a device to permanently implant the body as such are correctly classifiable under HS code 9021.3900.
6. The Committee therefore concluded that the instant goods will fall for classification under heading 9021.3900 which is more relevant with description of the goods in this case.
Signed by
Additional Collector-ll
Chairman PCT Committee
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